Bacterial Eradication Rates Research Articles

Efficacy of 1.5% levofloxacin otic solution in treating acute otitis externa: A post hoc analysis of ENT103-3001, a multicenter randomized double-blind parallel-group placebo-controlled phase III study in otitis media with persistent otorrhea

ObjectiveIn this post hoc analysis, we aimed to evaluate the efficacy of 1.5% levofloxacin (LVFX) otic solution for the treatment of acute otitis externa (AOE) in patients with nonintact tympanic membrane (NTM) accompanied by chronic suppurative and acute otitis media. MethodsDigital endoscopic images of the tympanic membrane and cavity were evaluated. In addition, the full analysis set from the original ENT103-3001 study was analyzed to determine the efficacy of the 1.5% LVFX otic solution in treating patients with otitis media with persistent otorrhea. AOE was diagnosed by a study-specific blinded independent review committee (BIRC) in the present study, which reviewed the presence of inflammatory findings, such as edema, erosion, and/or erythema (redness), in the external ear canal on the digital endoscopic images acquired at screening. The improvement in the inflammatory findings in each diseased ear was evaluated by examining the digital endoscopic images acquired at the end of treatment (EOT; including study discontinuation) and follow-up (F/U) visits. Data regarding residual purulent otorrhea at EOT and F/U visits were assessed by the BIRC of the ENT103-3001 study. Similarly, otological symptoms at EOT were recorded in the patients’ diaries, and the bacterial eradication rates were used from the ENT103-3001 study. Improvement was defined as the resolution of the inflammatory findings and purulent otorrhea. ResultsAmong the 201 patients with otitis media, 161 patients had AOE (LVFX group, 82; placebo group, 79). The difference (95% confidence interval) between the groups at EOT was 27.3% (12.7, 40.3), and the proportion of patients showing improvement in all inflammatory findings in the external ear canal in the LVFX group (47.6%, 39/82) was significantly higher than that in the placebo group (20.3%, 16/79; Fisher's exact test, p < 0.001). Similarly, the bacterial eradication rate in the LVFX group (94.3%, 66/70) was also significantly higher than that in the placebo group (10.3%, 7/68; Fisher's exact test, p < 0.001). ConclusionThe use of 1.5% LVFX otic solution resulted in a significantly higher rate of improvement in inflammatory findings in the external ear canal and bacterial eradication rate, indicating its efficacy. Thus, 1.5% LVFX otic solution may be an effective treatment for chronic suppurative otitis media and acute otitis media, as well as AOE with NTM.

Outcome of Levofloxacin in the Treatment of Lower Respiratory Tract Infection

Background: Levofloxacin, a broad-spectrum fluoroquinolone antibiotic, is commonly used in treating lower respiratory tract infections (LRTIs) like pneumonia and chronic bronchitis. Its effectiveness lies in its ability to inhibit bacterial DNA gyrase, leading to bacterial cell death. Clinical outcomes of levofloxacin in LRTI treatment have generally been positive, with high rates of bacterial eradication and symptom resolution. Objective: The present research aimed to determine whether levofloxacin is an effective and safe option for treating lower respiratory tract infections. Method: From January 2022 to January 2023, researchers analyzed data from 120 patients with a lower respiratory tract infection at a tertiary hospital. Sixty patients were split evenly between a control group and an observation group. Levofloxacin was administered at the standard dosage to the control group and at a significantly higher dose to the observation group. Both the clinical efficacy and adverse reaction rates were compared and contrasted between the two groups statistically. Results: The cure rate in the observation group was 53.33 percent, which was substantially greater than the cure rate in the control group, which was 36.67 percent. There is a statistically significant difference between them (P 0.05). The overall efficacy rate of the observation group was 93.33%, significantly higher than that of the control group (73.33%). There is a statistically significant difference between them (P 0.05). There was no statistically significant difference (P&gt;0.05) between the two groups due to the low incidence of adverse responses in both the observation and control groups. Conclusion: This research demonstrates that large dosages of levofloxacin have a stronger clinical curative impact on treating lower respiratory infections than lesser doses. It is worthwhile to promote the widespread adoption of this technique since it has the potential to greatly enhance the quality of patient care

Efficient water disinfection against antibiotic-resistant bacteria by visible-light heterogeneous photo-Fenton-like process with atomically dispersed Cu on graphitic carbon nitride as the catalyst

Waterborne microbial contamination poses significant environmental and health risks. Photocatalytic heterogeneous Fenton and Fenton-like processes can offer efficient pathogen removal, with benefits in recycling, solid–liquid separation, and byproduct avoidance. However, their low reaction efficiency and slow kinetics for low-valence metal regeneration are limitations. This study addresses these challenges by incorporating atomically dispersed Cu onto graphitic carbon nitride (g-CN) as a single-atom catalyst (SAC). The Cu atoms are stabilized by pyridinic N atoms through coordination, forming Cu-N4 catalytic sites that enhance photogenerated charge carrier transfer. This leads to a more efficient synergistic photocatalytic-Fenton-like reaction, generating more hydroxyl radicals and achieving effective water disinfection. Results show a 7-log bacterial inactivation of antibiotic-resistant Acinetobacter baumannii within 8 min, surpassing prior photocatalytic-Fenton-like disinfection systems. Density functional theory calculations confirm improved hydrogen peroxide adsorption, electron transport, and electron-hole separation in the Cu-N4 structure. The catalyst’s durability and stability were demonstrated through extensive cycling experiments, ion interference tests, and disinfection trials in various water matrices. Additionally, the Cu-SAC@CN catalyst, loaded onto a polytetrafluoroethylene membrane, achieved a 99% bacterial eradication rate within 20 min. This study provides valuable insights into the potential applications of heterogeneous photocatalytic-Fenton-like systems for efficient eradication of waterborne bacteria.

Photothermal Antibacterial and Osteoinductive Polypyrrole@Cu Implants for Biological Tissue Replacement.

The treatment of bone defects caused by disease or accidents through the use of implants presents significant clinical challenges. After clinical implantation, these materials attract and accumulate bacteria and hinder the integration of the implant with bone tissue due to the lack of osteoinductive properties, both of which can cause postoperative infection and even lead to the eventual failure of the operation. This work successfully prepared a novel biomaterial coating with multiple antibacterial mechanisms for potent and durable and osteoinductive biological tissue replacement by pulsed PED (electrochemical deposition). By effectively regulating PPy (polypyrrole), the uniform composite coating achieved sound physiological stability. Furthermore, the photothermal analysis showcased exceptional potent photothermal antibacterial activity. The antibacterial assessments revealed a bacterial eradication rate of 100% for the PPy@Cu/PD composite coating following a 24 h incubation. Upon the introduction of NIR (near-infrared) irradiation, the combined effects of multiple antibacterial mechanisms led to bacterial reduction rates of 99% for E. coli and 98% for S. aureus after a 6 h incubation. Additionally, the successful promotion of osteoblast proliferation was confirmed through the application of the osteoinductive drug PD (pamidronate disodium) on the composite coating's surface. Therefore, the antimicrobial Ti-based coatings with osteoinductive properties and potent and durable antibacterial properties could serve as ideal bone implants.

Fenton chemistry activation in metal-organic frameworks for synergistic bacteria eradication

The development of novel antibacterial strategies as alternatives to antibiotics is of great significance but remains considerable challenges due to the lack of safe, effective, and broad-spectrum agents. Here, we explored the potential of a biocompatible metal–organic framework Fe-MIL-53-NH2 (FM) for reactive oxygen species (ROS)-based antibacterial applications. However, FM was found to be catalytically inert due to the very weak reducibility of Fe3+ toward H2O2. To address this challenge, we incorporated a small amount of Co2+ (0.98 %) into FM (CFM), successfully activating Fenton chemistry and achieving a notable 5.5-fold improvement in Fenton activity. Density functional theory (DFT) calculations revealed that a very small amount of Co2+ doping significantly reduces the energy barrier of the Fenton reaction by shifting the d-band center to the Fermi level and optimizing the charge density of active Co atoms. We further enhanced the antibacterial properties of CFM by modifying it with the photothermal agent polydopamine (PDA), resulting in CFMP. Through the synergistic effects of ROS and photothermal properties, CFMP exhibited remarkable antibacterial activity, with bacterial eradication rates exceeding 99 % against both E. coli and S. aureus. Moreover, in vivo experiments demonstrated the exceptional efficacy of CFMP in sterilizing S. aureus-infected wounds, while causing negligible damage to other major organs. This study not only highlights the role of atom engineering in activating Fenton reaction, but also provides rational designs for a synergistic antibacterial strategy via powerful MOFs chemistry.

COMPARISON OF ANTIBACTERIAL AND SOME PHYSICAL PROPERTIES OF KNITTED FABRICS PRODUCED FROM BAMBOO, COTTON AND VISCOSE FIBER

Cotton, bamboo, and viscose fibers were examined in this study for their suitability in textile production. Bamboo, being a regenerated cellulosic fiber, has gained popularity in the industry due to its ecological properties. Fabrics made from bamboo exhibit comfort, wrinkle resistance, and thermal regulation. Additionally, they possess natural antibacterial, hypoallergenic, and biodegradable properties, along with high moisture absorption, shine, softness, and UV protection. The study compared knitted fabrics from these fibers, evaluating their water vapor permeability, air permeability, burst strength, water absorbency, abrasion resistance, and antibacterial properties according to international standards. Results showed that bamboo and cotton fibers have similar water vapor permeability, both higher than viscose fibers. Bamboo fiber's air permeability is notably higher than cotton and viscose fibers. Moreover, bamboo's water absorption surpasses cotton and viscose, leading to better sweat absorption. Bamboo fiber also demonstrated superior antibacterial properties compared to cotton and viscose, with higher bacterial eradication rates. Fabrics made from bamboo exhibited higher bursting strength and comparable pilling values to cotton, outperforming viscose. Overall, bamboo fiber demonstrated better air permeability, water absorbency, antibacterial properties, abrasion resistance, and bursting strength compared to cotton and viscose, making it a desirable choice for cool and comfortable textiles.

Clinical efficacy and safety of tigecycline based on therapeutic drug monitoring for carbapenem-resistant Gram-negative bacterium pneumonia in intensive care units

BackgroundWe investigated the associations between the different doses of tigecycline, its efficacy and safety, and the role of tigecycline therapeutic drug monitoring for patients in the intensive care unit.MethodsThis study was a single-center cohort including patients infected with multidrug-resistant Acinetobacter baumannii (MDR-AB) and multidrug-resistant Klebsiella pneumoniae (MDR-KP) causing pulmonary infections. The steady-state plasma concentration after tigecycline administration was determined by High-Performance Liquid Chromatography (HPLC) in patients admitted to the ICU between October 2020 and December 2021. Multivariate analyses of tigecycline’s clinical efficacy and safety were performed to control confounding factors.ResultsFor this study, we included 45 patients and 45 blood samples to determine steady-state trough concentrations of tigecycline. All patients were divided into the High Dose (HD) and Standard Dose (SD) groups. The median trough concentration of tigecycline was 0.56 μg/mL in the HD group, which was higher than in the SD group (0,21 μg/mL), p = 0.000. There was no significant difference between the two groups of patients in terms of bacterial eradication rate, mortality rate, and clinical efficacy. Multiple regression analysis showed that the ICU days were correlated with mortality OR 1.030(1.005–1.056), p = 0.017. APACHE II was significantly associated with clinical efficacy OR 0.870(0.755–1.002), p = 0.045. The level of fibrinogen decline in the HD group was significantly higher than in the SD group (-3.05 ± 1.67 vs -1.75 ± 1.90), p = 0.038. We identified that age and tigecycline treatment duration influenced fibrinogen decline.ConclusionsTigecycline plasma concentrations are significantly increased when using a high dose. However, the plasma concentration of tigecycline is not correlated with clinical efficacy and adverse reactions. Fibrinogen decline appears to be related to the patient’s age and days of tigecycline. Large sample data are still needed to confirm the clinical guidance significance of tigecycline TDM.

Evaluating the efficacy of inhaled amikacin as an adjunct to intravenous combination therapy (ceftazidime and amikacin) in pediatric cystic fibrosis pulmonary exacerbation.

Background: Pseudomonas aeruginosa is the most common microorganism found in the sputum culture of Cystic fibrosis (CF) patients causing the pulmonary destruction. Aminoglycosides have a low diffuse rate from lipid membranes, and respiratory system secretions. Regarding the burden of pulmonary exacerbation caused by the pseudomonas aeruginosa in cystic fibrosis patients in the long term and the limited number of clinical trials focused on appropriate treatment strategies, the present study evaluated the concurrent inhaled and intravenous aminoglycoside antibiotics for pulmonary exacerbation caused by the pseudomonas aeruginosa as a safe and effective treatment in children. Method: This study was a blinded, randomized clinical trial phase conducted in a tertiary referral pediatric teaching hospital from May 2021 to May 2022. The patients were randomly allocated to receive intravenously administered ceftazidime and Amikacin alone or with inhaled Amikacin. Forced expiratory volume (FEV1), Amikacin via the level, kidney function tests, audiometry, inflammatory markers (erythrocyte sedimentation rate and C-reactive protein), hospital stay, and bacterial eradication rate were compared in two therapy groups. Results: the average FEV1 has increased by 47% in Neb + group compared to Neb- group following treatment. Hospital stay was lower in Neb + group. No renal toxicity or ototoxicity was observed in both therapy groups. Pseudomonas aeruginosa eradication rate Neb- and Neb + groups were 44% and 69%, respectively (p-value = 0.15). Conclusion: Concurrent inhaled and intravenous Amikacin is safe and effective to treat Pseudomonas aeruginosa exacerbation in CF patients. Moreover, co-delivery antibiotics' route treatment increased the eradication rate. Although not statistically significant, never the less, it is clinically relevant. The intervention reduced the length of hospitalization in this group. Clinical Trial Registration: clinicaltrials.gov, identifier [IRCT20120415009475N10].

Efficacy and safety of 1.5% levofloxacin otic solution for the treatment of otitis media in a multicenter, randomized, double-blind, parallel-group, placebo-controlled, phase III study

ObjectiveThe present study aimed to evaluate the efficacy and safety of 1.5% levofloxacin (LVFX) otic solution for the treatment of patients with otitis media. MethodsThis multicenter, randomized, double-blind, parallel-group, placebo-controlled phase 3 trial was conducted at 34 institutions in Japan. A total of 202 patients with chronic suppurative otitis media (CSOM) or acute otitis media (AOM) were randomized into either the LVFX group or placebo group. A total of 6–10 drops of 1.5% otic solution of LVFX or its matching placebo were administered in the diseased ear twice daily, in the morning and evening for up to 10 days. Images corresponding to three clinical findings—purulent otorrhea, hyperemia (redness), and granulation tissue formation in the middle ear and tympanic membrane—for each diseased ear were evaluated using digital endoscopy by a blinded central independent review committee (BICRC) at each visit after treatment administration. ResultsIn total, the data of 201 participants (LVFX group, 99; placebo group, 102) were analyzed. The proportion of patients with disappearance (improvement rate) of all three clinical findings at the end of treatment or discontinuation by the BICRC was 46.5% (46/99) in the LVFX group and 23.5% (24/102) in the placebo group, and the difference (95% confidence interval) between the groups was 22.0% (8.7, 34.2), with a significantly higher improvement rate in the LVFX group than in the placebo group (p = 0.001; Cochran–Mantel–Haenszel test), demonstrating the efficacy of LVFX. The bacterial eradication rates were 93.9% (77/82) and 12.5% (11/88) in the LVFX and placebo groups, respectively, and the rate was significantly higher in the LVFX group than in the placebo group (p < 0.001). Treatment-related adverse events (AEs) occurred in 5.1% (5/99) and 7.8% (8/102) of the patients in the LVFX and placebo groups, respectively, and no significant difference was noted in incidence rate between the groups. ConclusionThe clinical efficacy of 1.5% LVFX otic solution for CSOM and AOM was demonstrated by the resolution of inflammation in the middle ear and tympanic membrane as well as through the high bacterial eradication rate observed. No deaths or serious treatment-related AEs were observed. The study provided confirmation that 1.5% LVFX otic solution is a safe, well-tolerated, and effective treatment for CSOM and AOM.

Six-Month Doxycycline Is Safe and Effective As Upfront Monotherapy for Stage-I Malt Lymphoma of the Ocular Adnexae: Primary Endpoint Results of the IELSG39 Trial

Background: Overall survival of patients with limited-stage ocular adnexa MALT lymphoma (OAML) is favorable, with a few lymphoma-related deaths. In geographical areas where OAML is frequently associated with Chlamydia psittaci (Cp) infection, bacterial eradication with doxycycline monotherapy is associated with good disease control. In the IELSG27 trial (Ferreri, et al. JCO 2012), a 3-week regimen of doxycycline has been associated with an overall response rate (ORR) of 65% and a 2-year progression-free survival (PFS) of 60%. However, successful Cp eradication has been achieved only in half of patients, which strongly conditioned therapeutic results. This phenomenon is explained by the fact that, during its biological cycle, Cp often persists within macrophages under the form of elementary bodies, which is a metabolically inert condition, refractory to antibiotics. An extended exposure to effective antibiotics could result in a higher bacterial eradication rate and better lymphoma control. This hypothesis was tested in an international phase II trial (IELSG39), where patients with limited-stage OAML were treated with a six-month regimen of doxycycline. Herein, we report primary endpoint results. Methods: HIV-negative adults with newly diagnosed stage IEA OAML, ECOG-PS 0-2 and measurable disease were enrolled and treated with doxycycline 100 mg twice daily for four weeks followed by four weeks rest, repeated for three times (treatment duration: six months). Patients with HBV or HCV seropositivity, myasthenia gravis or systemic lupus erythematous were excluded. Cp infection was assessed by TETR-PCR analysis on tumor tissue at diagnosis and monitored on conjunctival swabs and PBMC every six months. Tumor response was assessed by orbit MRI and ophthalmologist evaluation every six months. The primary endpoint was the 2-year PFS, a Fleming phase 2 design was used. The main goal of this experimental treatment was to improve the efficacy of antibiotic therapy reported in the IELSG27 trial (2-year PFS= 60%; P0) to a 2-year PFS of 75% (P1). To detect such a difference, a total number of 30 patients with Cp-positive OAML was required (one-sided test, type I error 5% and power 80%); whenever ≥17 patients with Cp-positive OAMZL were progression-free at 2 years, the experimental therapy would be considered effective. Results: 44 patients (median age 58 yo, range 31-85; male:female ratio 0.63) were enrolled in eight participating centres, between March 2013 and May 2016. Lymphoma site was conjunctiva in 27 (61%) patients, orbit soft tissues in 10 (23%), lachrymal gland in 6 (14%), and eyelid in one (2%). Cp DNA was detected in 20 (71%) of 28 assessed patients; TETR-PCR analysis is ongoing in 16. Treatment was well tolerated; all patients completed the treatment in the planned time. Grade 1-2 nausea was complained by 8 (18%) patients. The best objective response was complete in 14 patients and partial in 14, with an ORR of 64% (95% CI= 50-78), 11 patients had stable disease, and five experienced progressive disease. The time to the best response was longer than one year in 11 (46%) of 24 patients with responsive disease (median 9 months; range 3-34). At two years from enrolment (primary endpoint), 30 patients remain relapse-free; 17 of them had a Cp-positive OAML. At a median follow-up of 79 months (range 33-112), 23 patients remain relapse-free, with a 2- and 5-year PFS of 72% (95%CI= 71-73) and 53% (95%CI= 47-58), respectively; all patients are alive. Patients with Cp-positive lymphoma had a better PFS (5-year: 60% and 37%; p= 0.14). A post-hoc explorative analysis showed that this six-month doxycycline treatment was associated with a trend towards better PFS in comparison with the shorter regimen used in the IELSG27 trial (median follow-up 75 months; range 5-155), both when whole populations (upper figure) and Cp-positive subgroups (lower figure) were considered. Conclusions: The assessed six-month administration regimen of doxycycline was safe and effective in patients with stage-I OAML. This experimental treatment achieved the predetermined efficacy threshold and compares favorably with the 3-week regimen used in the IELSG27 trial, suggesting that a prolonged exposure to antibiotics improves lymphoma control. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

DNase inhibits early biofilm formation in Pseudomonas aeruginosa- or Staphylococcus aureus-induced empyema models.

Anti-infection strategies against pleural empyema include the use of antibiotics and drainage treatments, but bacterial eradication rates remain low. A major challenge is the formation of biofilms in the pleural cavity. DNase has antibiofilm efficacy in vitro, and intrapleural therapy with DNase is recommended to treat pleural empyema, but the relevant mechanisms remain limited. Our aim was to investigate whether DNase I inhibit the early biofilm formation in Pseudomonas aeruginosa- or Staphylococcus aureus-induced empyema models. We used various assays, such as crystal violet staining, confocal laser scanning microscopy (CLSM) analysis, peptide nucleic acid-fluorescence in situ hybridization (PNA-FISH), and scanning electron microscopy (SEM) analysis. Our results suggested that DNase I significantly inhibited early biofilm formation in a dose-dependent manner, without affecting the growth of P. aeruginosa or S. aureus in vitro. CLSM analysis confirmed that DNase I decreased the biomass and thickness of both bacterial biofilms. The PNA-FISH and SEM analyses also revealed that DNase I inhibited early (24h) biofilm formation in two empyema models. Thus, the results indicated that DNase inhibited early (24h) biofilm formation in P. aeruginosa- or S. aureus-induced rabbit empyema models and showed its therapeutic potential against empyema biofilms.

Exploring microwave irradiation as a method to disinfect contact lens cases

PurposeBiofilm formation caused by infrequent contact lens case replacement and the ineffectiveness of multi-purpose solutions (MPS) on biofilm removal is associated with high rates of bacterial keratitis infections. This study demonstrated biofilm elimination from the contact lens case by microwave irradiation. MethodsStaphylococcus aureus biofilms indicative of 3–9 months of contact wear were cultured in contact lens cases and visualized with crystal violet (CV) staining. Biofilms in contact cases were then exposed to four treatment regimens: No treatment (n = 8), 45 s microwave irradiation (n = 8), tap water (n = 6), and MPS (n = 9). Bacterial survival was assessed by colony forming unit (CFU) assay using streak dilutions. ResultsVisualization of the biofilms through CV staining revealed that biofilms coalesce between ribs of the contact case. In 5/8 cases no CFU were cultivated from the case after treatment with microwave irradiation. In tap water and MPS the first dilution averaged 6 ± 2 and 31 ± 13 CFUs per plate, respectively, while microwave irradiation averaged < 1 CFU per plate. In Dilution 2, the average reduced to 0.7 ± 0.7 and 6 ± 5 CFUs per plate for tap water and MPS, respectively, while microwave irradiation had 0 CFUs in Dilution 2. ConclusionBiofilms that coalesce between the ribs of the contact case pose a threat because this area is difficult to thoroughly scrub and could act as a basis for infection through fouling of contact lenses. Of the four treatment regimens, microwave irradiation displayed the most consistent and highest rate of bacterial eradication. Tap water was less effective compared to microwave irradiation, and poses other harmful side effects, but greatly reduced CFU count compared to no treatment. MPS displayed the poorest bacterial eradication of the treatments. Thus, microwave irradiation is worth further investigation as a viable in-home disinfecting option.

Hematologic Malignancies and Carbapenem Resistance: A Multicentre Retrospective Study from Chinese People

Background: Tigecycline has broad spectrum activity against multidrug-resistant (MDR) bacteria, but few investigations of tigecycline in febrile neutropenic (FN) patients with malignancy are available. This study attempts to investigate the efficacy and safety of tigecycline in FN and carbapenem resisant patients with hematologic malignancies.Methods: The study of 109 patients with hematologic diseases and FN were retrospectively analyzed. They are unresponsive to carbapenems for 3~5 days before receiving tigecycline (loading dose 100 mg; then 50 mg every 12 hours). Clinical response to treatment was defined as clinical cure, improvement or failure. Meanwhile, the adverse events were documented.Results: The median duration of neutropenia was 15 days (ranged from 1 to 83d). Out of 109 patients, 96 (88.1%) had respiratory infection, while 33 (30.3%) had bloodstream infection. The total response rate of tigecycline was 65.1%. The bacterial eradication rates and bacterial hypothetical eradication were 25.9% and 24.1%, respectively. The clinical effective rate was 85.7% when tigecycline was administered for more than 9 days, while just 48.3% when administered for less than 9 days (p< 0.001). Patients with bloodstream infection got a worse efficacy than those without (41.2% vs 69.6%, p=0.024). For patients whose absolute neutrophil counts were less than 0.1×109/L, the clinical effective rate decreased obviously (59.8%, vs.86.4%, p=0.019). The side-effects were well tolerated. No lethal adverse events were observed.Conclusions: Our results demonstrated tigecycline was effective and safe for patients unresponsive to carbapenems with FN, combination and prolonged duration of tigecycline is recommended, and these results need to be further studied. DisclosuresNo relevant conflicts of interest to declare.

Clarithromycin versus Amoxicillin alone or with Clavulanate in Acute Maxillary Sinusitis: A Meta-analysis of Clinical Trials

Objective: A meta-analysis was performed to explore the relative effects of clarithromycin and amoxicillin (with or without clavulanate potassium) in the treatment of acute maxillary sinusitis. Methods: Six studies were identified in the peer-reviewed literature. All were randomized single-blind (investigator-blind) or open-label trials in outpatients diagnosed with acute maxillary sinusitis. A total of 1580 patients were enrolled, of whom 1194 were clinically evaluable. The total daily dose of clarithromycin was 1000 mg; the total daily dose of amoxicillin (with or without clavulanate potassium) was either 1500 or 2000 mg. The duration of study drug treatment varied from 8 to 14 days. Endpoints comprised clinical and radiological success within 48 h of the end of study drug treatment plus bacteriologic cure and eradication. Success and cure rate differences were analyzed using fixed- and random-effect models. The absence of between-study heterogeneity was tested using Cochran’s Q-test. Results: Clinical success rates varied between 85.8% and 97.9% for clarithromycin and between 84.2% and 96.8% for amoxicillin. The combined rate difference in clinical success rates between clarithromycin and amoxicillin was +1.9% (P=0.14). Radiological success rates (four studies) varied from 78.2% to 94.0% for clarithromycin and 79.7% to 95.0% for amoxicillin, with a combined rate difference of zero (P=1.00). Bacteriologic cure rates (four studies) were 87.1–94.6% for clarithromycin, compared with 89.8–98.1% for amoxicillin, with a combined difference in cure rates of –3.2% (P=0.16). Overall bacterial eradication rates were comparable between the two treatments (clarithromycin, 89.3%; amoxicillin, 92.1%). Conclusion: These data, with their limitations properly acknowledged, identify clarithromycin as a valid and viable alternative to amoxicillin for the treatment of acute maxillary sinusitis in adults.

A randomized, active-controlled, multicentre clinical trial to evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated or complicated urinary tract infection

Purpose To evaluate the efficacy and safety of oral sitafloxacin versus levofloxacin in Chinese adults with acute uncomplicated urinary tract infection (UTI) or complicated UTI. Methods In this randomized, active-controlled clinical trial, the patients with acute uncomplicated UTI were randomized to receive sitafloxacin 100-mg once-daily (qd) or levofloxacin 500-mg qd orally for 3–5 days. The patients with complicated UTI were randomized to receive sitafloxacin 100-mg twice daily or levofloxacin 500-mg qd orally for 10–14 days. The primary endpoint was the clinical efficacy at test-of-cure (TOC) visit. Results At TOC visit, the clinical cure rate was 89.2% (58/65) in sitafloxacin group and 97.1% (68/70) in levofloxacin group for the patients with acute uncomplicated UTI corresponding to the bacterial eradication rate of 97.1% (34/35) and 97.6% (41/42) (all p > .05), respectively. For the patients with complicated UTI, the clinical cure rate was 81.8% (27/33) in sitafloxacin group and 76.9% (20/26) in levofloxacin group corresponding to the bacterial eradication rate of 93.3% (14/15) and 63.6% (7/11) (all p > .05), respectively. Sitafloxacin and levofloxacin showed similar incidence of drug-related adverse events. Conclusions Oral sitafloxacin is as effective and safe as levofloxacin in treating acute uncomplicated and complicated UTI. KEY MESSAGE: Oral sitafloxacin showed similar clinical cure rate and bacterial eradication rate as levofloxacin for treatment of complicated and uncomplicated urinary tract infections (UTIs) in a randomized, active-controlled, multicentre clinical trial. Oral sitafloxacin is safe and well-tolerated in treating acute uncomplicated and complicated UTIs in Chinese adults. Sitafloxacin is a promising alternative treatment option for UTIs in adults.

PIN52 CAN BESIFLOXACIN USE DECREASE BACTERIAL CONJUNCTIVITIS BURDEN? - AN ESTIMATION VIA DYNAMIC TRANSMISSION MODELLING

Bacterial conjunctivitis is a common ocular infection associated with contagious spread and outbreaks. Besifloxacin is a topical ophthalmic fluoroquinolone indicated for bacterial conjunctivitis. We have developed a dynamic transmission model which produced a country level estimate for the decrease in case numbers during an outbreak. A simple epidemic Sensitive-Infectious-Sensitive (SIS) model was used to estimate case numbers during an outbreak over a 30-day period. Model parameters were based on published in-vivo and in-vitro data of bacterial eradication rates and shorter time-to-bactericidal activity (2-8 times shorter than moxifloxacin and ciprofloxacin). Two scenarios were used for this estimation: 1) Besifloxacin was assumed to stop contagious spread 0.6 days earlier than comparative antibiotics, and 2) Besifloxacin was assumed to prevent contagious spread 0.5 days earlier than comparative antibiotics. Under the baseline assumptions, the number of new cases were estimated as 3 new cases/1,000 persons over 30 days. In Scenario 1, the number of new cases was found to decrease to 1.8 cases/1,000 persons over 30 days. In Scenario 2, the number of new cases decreased to 1.5/1,000 persons in 30 days. When these estimates were applied to the total number of bacterial conjunctivitis cases over 1 year in Turkey, even if besifloxacin was assumed to be used in only 1% of cases, it was found that 34,518 and 39,368 of bacterial conjunctivitis cases would be prevented according to Scenario 1 and 2, respectively. The SIS model showed besifloxacin could prevent a significant number of new bacterial conjunctivitis cases in Turkey by potentially eradicating bacteria faster compared to other antibiotics which could potentially lead to savings in healthcare resource utilization.

Ozenoxacin, a New Effective and Safe Topical Treatment for Impetigo in Children and Adolescents

Background: Ozenoxacin is a topical antibiotic approved in Europe to treat non-bullous impetigo in adults and children aged ≥6 months. This analysis evaluated the efficacy and safety of ozenoxacin in paediatric patients by age group. Methods: Pooled data for patients aged 6 months to <18 years who had participated in a phase I or in two phase III clinical trials of ozenoxacin 1% cream were analysed by age group: 0.5–<2, 2–<6, 6–<12, and 12–<18 years. Results: The combined population comprised 529 patients with non-bullous impetigo treated with ozenoxacin (n = 239), vehicle (n = 201), or retapamulin as internal validation control (n = 89). Studies were well matched for extent and severity of impetigo and therapeutic schedule (twice daily application for 5 days). The clinical success rate after 5 days’ treatment (day 6–7, end of therapy), and microbiological success rates after 3–4 days’ treatment and at the end of therapy, were significantly higher with ozenoxacin than vehicle (p < 0.0001 for all comparisons). Clinical and bacterial eradication rates were higher with ozenoxacin than vehicle in each age group. No safety concerns were identified with ozenoxacin. One (0.3%) of 327 plasma samples exceeded the lower limit of quantification for ozenoxacin, but the low concentration indicated negligible systemic absorption. Conclusion: This combined analysis supports the efficacy and safety of ozenoxacin administered twice daily for 5 days. Ozenoxacin 1% cream is a new option to consider for treatment of non-bullous impetigo in children aged 6 months to <18 years.

Treating with besifloxacin for acute bacterial conjunctivitis: a Meta-analysis.

To evaluate the relative efficacy and safety of besifloxacin for treatment of acute bacterial conjunctivitis. A comprehensive search in PubMed, EMBASE Web of Science, Cochrane Central Database and CNKI was undertaken for randomized controlled trials (RCTs) comparing besifloxacin with other treatments or placebo. The primary outcome measures were clinical resolution, rates of bacterial eradication, individual clinical outcomes, cure rates, and bacterial eradication rates of different kinds of pathogens. Safety outcomes were the number of adverse effects (AEs). The final search was performed on August 2018. Six RCTs were included. Four studies compared the efficacy and safety of besifloxacin with placebo, 1 study compared besifloxacin with moxifloxacin, and 1 study compared besifloxacin with gatifloxacin. A total of 2780 patients met the inclusion criteria. Besifloxacin presented higher efficacy and safety than did placebo in clinical resolution, rates of bacterial eradication, individual clinical outcomes, cure rates, bacterial eradication rates of different kinds of pathogens and the number of AEs. There was no significant difference between besifloxacin and moxifloxacin or gatifloxacin in the comparison items mentioned above. Besifloxacin is highly effective and safe for treatment of acute bacterial conjunctivitis. Further comparative trials regarding the effect of besifloxacin for treatment of acute bacterial conjunctivitis will aid in treatment decisions.

Safety and efficacy profile of ozenoxacin 1% cream in pediatric patients with impetigo.

BackgroundOzenoxacin is a topical antibiotic approved in the United States for treatment of impetigo in adults and children age ≥2 months. This analysis evaluated the efficacy and safety of ozenoxacin in specific pediatric age groups.MethodsData for children aged 2 months to <18 years recruited from eight countries who had participated in phase 1 and 3 trials of ozenoxacin were extracted and analyzed by age range.ResultsAcross studies, 644 pediatric patients with impetigo received ozenoxacin 1% cream (n = 287) or vehicle (n = 247). One study included retapamulin 1% ointment as the internal validity control (n = 110). The clinical success rate at the end of treatment and bacterial eradication rates after 3 to 4 days of treatment and at the end of treatment were significantly higher with ozenoxacin than vehicle (all p < .0001). The clinical and microbiologic success rates were higher with ozenoxacin than vehicle in the age groups of 0.5 to <2 years, 2 to <6 years, 6 to <12 years, and 12 to <18 years and were comparable to vehicle in the 2 to <6 months age group, although patient numbers were low (≤5 per treatment arm). No safety concerns with ozenoxacin were identified. Of the 362 plasma samples derived from 38 patients, four slightly exceeded the lower limit of quantification, indicating negligible systemic absorption.ConclusionThe results of this analysis suggest that ozenoxacin 1% cream is an effective and safe treatment for impetigo in pediatric patients aged 2 months to <18 years.

Efficacy and safety of pazufloxacin mesylate eye drops for bacterial conjunctivitis: a multicenter randomized, double-masked, parallel controlled clinical trial

Objective To compare the clinical efficacy and safety following the topical application of pazufloxacin mesylate eye drops with levofloxacin eye drops (LOFX) for bacterial conjunctivitis. Methods A multicenter, randomized, investigator-masked, parallel-controlled clinical trial was performed.Five hundred and twenty eyes of 520 patients with bacterial conjunctivitis were enrolled from March to October 2008 in seven ophthalmic centers in China.The patients were randomized into trial group and control group in 3∶1 ratio with the 390 eyes in the trial group and 130 eyes in the control group.Pazufloxacin mesylate eye drops was topically used 4 times per day for consecutively 7-14 days in the trial group, and levofloxacin eye drops was used in the same way in the control group.Microbiological cultures for conjunctiva sac secretions and drug sensitive test were carried out before and at the end of the administration of eye drops.The signs and symptoms were observed and scored before treatment and 0, 3, 7 and 14 days after treatment.The adverse events following the administration of the eye drops were evaluated and compared. Results The intention to treat analysis (ITT) showed that the cure rate was 59.38% in the trial group and 60.47% in the control group, with the effective rate 88.80% and 86.05%, respectively, with an insignificant difference between the two groups (χ2=0.12, P=0.72). The clinically evaluable analysis (CE) exhibited that the cure rates were 63.48% in the trial group and 63.87% in the control group, with the effective rate 92.46% and 88.24%, which was not significantly different between them (χ2=0.54, P=0.46). The modified-ITT analysis (mITT) showed that the cure rates were 60.57% in the trial group and 62.07% in the control group, with the effective rate 90.32% and 88.51%, without significant difference between the two groups (P>0.05). Based on microbiologically evaluable analysis (ME), the clinical cure rates were 63.71% and 63.41% in the trial group and control group, and the effective rates were 93.44% and 90.24%, respectively.There was no significantly difference between the both groups (P>0.05). In the trial group and control group, the bacterial eradication rate was 89.42% and 90.80% based on ITT, 90.11% and 92.77% based on CE, respectively.There was no significant difference in incidences of adverse events following the administration of the drug between the trial group and control group, including ocular tolerance, burning sensation, pricking and itching (P=0.34). Conclusions The effectiveness and adverse response were resemble between Pazufloxacin mesylate eye drops and LOFV following the topical application for bacterial conjunctivitis, which indicate that Pazufloxacin mesylate eye drops is effective and safe. Key words: Pazufloxacin mesylate eye drops; Conjunctivitis, bacterial; Multicenter randomized double-blind controlled clinical trial; Treatment outcome; Safety