Use Of Fluoroquinolone Antibiotics Research Articles

Infection risk reduction with povidone-iodine rectal disinfection prior to transrectal prostate biopsy: an updated systematic review and meta-analysis

BackgroundTo prevent infectious complications after transrectal ultrasound-guided prostate biopsy (TRUS-PB), some studies have investigated the efficacy of rectal disinfection using povidone-iodine (PI) and antibiotic prophylaxis (AP).ObjectiveTo summarize available data and compare the efficacy of rectal disinfection using PI with non-PI methods prior to TRUS-PB.Evidence acquisitionThree databases were queried through November 2023 for randomized controlled trials (RCTs) analyzing patients who underwent TRUS-PB. We compared the effectiveness of rectal disinfection between PI groups and non-PI groups with or without AP. The primary outcomes of interest were the rates of overall infectious complications, fever, and sepsis. Subgroups analyses were conducted to assess the differential outcomes in patients using fluoroquinolone groups compared to those using other antibiotics groups.Evidence synthesisWe included ten RCTs in the meta-analyses. The overall rates of infectious complications were significantly lower when rectal disinfection with PI was performed (RR 0.56, 95% CI 0.42–0.74, p < 0.001). Compared to AP monotherapy, the combination of AP and PI was associated with significantly lower risk of infectious complications (RR 0.54, 95% CI 0.40–0.73, p < 0.001) and fever (RR 0.47, 95% CI 0.30–0.75, p = 0.001), but not with sepsis (RR 0.49, 95% CI 0.23–1.04, p = 0.06). The use of fluoroquinolone antibiotics was associated with a lower risk of infectious complications and fever compared to non-FQ antibiotics.ConclusionRectal disinfection with PI significantly reduces the rates of infectious complications and fever in patients undergoing TRUS-PB. However, this approach does not show a significant impact on reducing the rate of sepsis following the procedure.

Pros and cons of the use of fluoroquinolone antibiotics in patients with kidney disease.

Pros and cons of the use of fluoroquinolone antibiotics in patients with kidney disease.

Antimicrobials in a rabbit semen extender: effects on reproduction

The use of fluoroquinolone antibiotics was legally restricted by the European Commission in March 2019. Since the extender for rabbit semen Galap® contained this antibiotic, it became necessary to modify it. The purpose of this study was to search for another molecule, based on its antimicrobial activity and also on the conservation, motility and fertility of semen diluted with the new extender. Several bacterial strains were isolated from 10 poor-quality ejaculates, including Enterococcus spp., Staphylococcus aureus and Proteus spp. They were then tested for antimicrobial susceptibility. Out of 15 antibiotics evaluated, gentamicin was the one targeting such bacteria. In vivo tests were then carried out to assess the effects of this antibiotic change on sperm parameters. Up to 26 pools of good quality semen (total motility &gt;70%) were diluted in original Galap® or in this extender with gentamicin. Ejaculates were analysed on the day (D) of collection and up to 6 d of storage at +17°C. After 24 h storage, the motility in the new extender was reduced by 7.7% compared to the original; this decrease did not worsen by storing. After 6 d of storage, no difference between the two media was detected. A total of 360 females were then inseminated with pools of 4 to 5 good quality semen diluted 1:10 in both extenders, following the routine protocol of rabbit semen processing centres. There was no difference in female fertility or prolificacy between both formulations. In conclusion, these preliminary results suggest that the addition of gentamicin to this extender is useful and also has no adverse effect on fertility or prolificacy.

Enhanced electron transfer for activation of peroxymonosulfate via MoS2 modified iron-based perovskite

ABSTRACT The increasing use of fluoroquinolone antibiotics, which are found in various environmental media, is a constant threat to ecological safety and human health. In this paper, SrFeO3@MoS2 heterogeneous catalyst was prepared to activate peroxymonosulfate (PMS) for the degradation of levofloxacin (LVO). The characteristics of SrFeO3@MoS2 samples were studied and the optimum conditions for the removal of LVO by SrFeO3@MoS2/PMS system were investigated. The removal of LVO by the SrFeO3@MoS2-0.3/PMS system could reach 96.06% within 20 min of reaction. The effect of inorganic anions (SO4 2−, Cl−, NO3 − and H2PO4 −) commonly found in actual water bodies on catalytic reaction was explored. The reusability investigation revealed that the catalyst could still remove 88.06% of LVO within 20 min after four cycles. Moreover, SO4 •−, •OH and 1O2 were identified by Electron Paramagnetic Resonance (EPR) tests and scavenger experiments, where the SO4 •− and •OH were dominant reactive species. Combining with the XPS characterisation, the activation mechanism of SrFeO3@MoS2-0.3/PMS was proposed, and the oxygen vacancies and transition metals on the sample surface were active sites of PMS activation. Furthermore, the possible degradation pathways of LVO were well-established based on the detected intermediates.

Antibiotic prophylaxis for transrectal prostate biopsy : In the context of restricted indications for fluoroquinolones and antibiotic stewardship

HintergrundDie transrektale Prostatastanzbiopsie (TRPB) gehört zu den häufigsten interventionell-urologischen Eingriffen in Deutschland. Es wird leitliniengerecht eine kurzeitige periprozedurale Antibiotikaprophylaxe (PAP) empfohlen. Die Indikationsrücknahme von Fluorchinolonen als PAP-Substanz durch das Bundesinstitut für Arzneimittel und Medizinprodukte macht die Verwendung alternativer Substanzen notwendig.ZieleIm Rahmen der Studie wurde die klinische Praxis der PAP bei TRPB mit Fokus auf infektiöse Komplikationen im Vergleich zwischen Fluorchinolon- und Cotrimoxazol-PAP evaluiert.MethodikEs handelt sich um eine retrospektive monozentrische Auswertung klinischer Routinedaten von Patienten mit TRPB zwischen 03.01.2019 und 28.01.2021.ErgebnisseEs wurden 508 erwachsene männliche Patienten eingeschlossen, das mediane Alter betrug 68 Jahre. 55,9 % erhielten eine Cotrimoxazol-PAP, 40,0 % eine Fluorchinolon-PAP. Insgesamt traten in 5,5 % postinterventionelle Komplikationen auf, davon 50,0 % infektiöse Komplikationen. Der Vergleich von Cotrimoxazol- und Fluorchinolon-PAP ergab keinen Unterschied der Komplikationsraten. Bei aufgrund von Komplikationen durchgeführten mikrobiologischen Urinuntersuchungen zeigten sich Erregernachweise mit Resistenz gegenüber der zuvor eingesetzten PAP im Sinne einer Selektion.SchlussfolgerungEine Cotrimoxazol-PAP für TRPB ist verglichen mit dem bisherigen Standard einer Fluorchinolon-PAP nicht mit vermehrt infektiösen Komplikationen assoziiert. Die präinterventionelle Analyse von Keimspektrum und Resistenz ermöglicht den Einsatz einer gezielten Prophylaxe und kann somit Komplikationen reduzieren.

Fluoroquinolone-Induced Aortic Injury

According to clinical studies, the use of fluoroquinolone antibacterial agents is associated with such rare, but serious adverse reactions as aortic injuries. The aim of the study was to analyse scientific literature data on the risk of aortic injury during fluoroquinolone treatment. The analytical review showed that the risk factors for fluoroquinolone-induced aortic injury are male gender, age over 45 years, underlying aortic disease, as well as smoking and associated atherosclerosis. Clinical and morphological forms of fluoroquinolone-associated aortic injuries include dilatation (aneurysm development), dissection, and rupture. The analysis of data on the association between aortic injuries and the use of most common fluoroquinolones (ciprofloxacin, levofloxacin, and moxifloxacin) showed that development of aneurysm and dissection was most often observed for levofloxacin, and least often for ciprofloxacin. The mechanism of aortic injury is due to fluoroquinolone-mediated activation of matrix metalloproteinases which damage elastic components of vascular walls, as well as reduction in lysyl oxidase expression and collagen synthesis. The ability of fluoroquinolones to form complexes with magnesium ions reduces the availability of magnesium to the cell enzyme systems, which delays synthesis of extracellular matrix structural proteins, leads to metalloproteinase activation and calcification of the vascular walls. Prevention, early detection, and timely management of the above-mentioned issues depend on the awareness of different medical specialists about the risks of aortic injury associated with the use of fluoroquinolone antibiotics.

Comparative neurological safety of fluoroquinolones versus therapeutic alternatives.

Fluoroquinolones, one of the most commonly prescribed antibiotic classes, have been implicated in cases of central nervous system (CNS) and peripheral nervous system (PNS) adverse events, which highlights the need for epidemiologic studies of the neurological safety of fluoroquinolones. To evaluate the safety of fluoroquinolones with regard to risk of diagnosed neurological dysfunction. We conducted a propensity score-matched inception cohort study using claims data from a commercially insured population. Our study included adults prescribed an oral fluoroquinolone or comparator antibiotic between January 2000 and September 2015 for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, uncomplicated urinary tract infection, or acute bronchitis. Our outcomes were CNS dysfunction, and four separate but complementary PNS dysfunction outcomes. Cox proportional hazards models were estimated after matching on propensity scores fitted using the variables age, sex, epilepsy, hereditary peripheral neuropathy, renal dysfunction, diabetes, gabapentinoid use, statin use, isoniazid use, and chemotherapy use. Our cohort contained 976 568 individuals exposed to a fluoroquinolone antibiotic matched 1:1 with a comparator. Matching produced balance (standardized mean difference <0.1) on all variables included in the propensity score. The hazard ratio associated with fluoroquinolone exposure was 1.08 (95% confidence interval 1.05-1.11) for CNS dysfunction, and 1.09 (95% CI 1.07-1.11) for the most commonly occurring PNS dysfunction outcome. Fluoroquinolone antibiotic use was associated with the development of neurological dysfunction versus comparator antibiotic use in the adult population.

Fluoroquinolones: Blessings Or Curses.

Fluoroquinolones are one of the world's most valuable and popularly used categories of antimicrobial agents. This paper attempts to review the substantial progress of fluoroquinolones from their discovery to black box warning. Antibiotic drug choice will remain difficult in the presence of increasing resistance, but the introduction of fluoroquinolones has created a new and exciting era in antimicrobial treatment. These are a synthetic heterogeneous group of compounds used in both hospital and community practices to treat numerous severe infections. The era of quinolone antibiotics began with the serendipitous discovery of the quinolone prototype in 1962. The chronological development of fluoroquinolone reported that nalidixic acid was the first quinolone that gained popular choice for the treatment of urinary tract infection. The subsequent agents like levofloxacin, ofloxacin, norfloxacin, gatifloxacin, moxifloxacin, clinafloxacin, sparfloxacin, and ciprofloxacin were derived through side chain and nuclear manipulation from basic pharmacophore. The fluoroquinolone motifs have been found as a milestone, effective in certain infections that are respiratory tract infection, urinary tract infection, bone disorders, meningococcal and mycobacterial infections, sexually transmitted diseases, skin infections, etc. Fluoroquinolones are first entirely man-made antibiotics that exhibit antibacterial activity through the inhibition of topoisomerase II, topoisomerase IV and deoxyribonucleic acid gyrase, which is vital for chromosome replication and function. The post-marketing surveillance pointed out the favorable side effects associated with fluoroquinolones such as phototoxicity, QT interval prolongation and anaphylaxis. The discovery, development and clinical use of fluoroquinolone antibiotics in the last century contributed to a decline in morbidity and mortality rates.

Inpatient fluoroquinolone use in Veterans' Affairs hospitals is a predictor of Clostridioides difficile infection due to fluoroquinolone-resistant ribotype 027 strains.

Reduction in the use of fluoroquinolone antibiotics has been associated with reductions in Clostridioides difficile infections (CDIs) due to fluoroquinolone-resistant strains. To determine whether facility-level fluoroquinolone use predicts healthcare facility-associated (HCFA) CDI due to fluoroquinolone-resistant 027 strains. Using a nationwide cohort of hospitalized patients in the Veterans' Affairs Healthcare System, we identified hospitals that categorized >80% of CDI cases as positive or negative for the 027 strain for at least one-quarter of fiscal years 2011-2018. Within these facilities, we used visual summaries and multilevel logistic regression models to assess the association between facility-level fluoroquinolone use and rates of HCFA-CDI due to 027 strains, controlling for time and facility complexity level, and adjusting for correlated outcomes within facilities. Between 2011 and 2018, 55 hospitals met criteria for reporting 027 results, including a total of 5,091 HCFA-CDI cases, with 1,017 infections (20.0%) due to 027 strains. Across these facilities, the use of fluoroquinolones decreased by 52% from 2011 to 2018, with concurrent reductions in the overall HCFA-CDI rate and the proportion of HCFA-CDI cases due to the 027 strain of 13% and 55%, respectively. A multilevel logistic model demonstrated a significant effect of facility-level fluoroquinolone use on the proportion of infections in the facility due to the 027 strain, most noticeably in low-complexity facilities. Our findings provide support for interventions to reduce use of fluroquinolones as a control measure for CDI, particularly in settings where fluoroquinolone use is high and fluoroquinolone-resistant strains are common causes of infection.

Assessment of the risk of musculoskeletal adverse events associated with fluoroquinolone use in children: A meta-analysis.

The use of fluoroquinolone antibiotics has been restricted in children because of their potential to cause adverse musculoskeletal events. This study was performed to systematically evaluate whether there is a difference between fluoroquinolone and non-fluoroquinolone antibiotics in terms of their associated risk of adverse musculoskeletal events in children. Cochrane Library, Embase, and PubMed databases were used to retrieve studies related to fluoroquinolone and non-fluoroquinolone-induced musculoskeletal adverse events in children. A meta-analysis was performed using Stata 11. A total of 10 studies were included in the analysis. The combined results showed that there was no statistical difference between fluoroquinolone and non-fluoroquinolone groups in terms of musculoskeletal adverse events in children (risk ratio = 1.145, 95% confidence interval = 0.974 - 1.345, P = .101). Subgroup analysis was performed using a random-effects model. Here, the effects on the trovafloxacin and levofloxacin groups were significantly different from that of the control group. However, musculoskeletal adverse events due to either drug was not reported after long-term follow-up. The results showed that fluoroquinolone and non-fluoroquinolone antibiotics were not different in terms of their ability to cause musculoskeletal adverse events in children. For this reason, fluoroquinolone antibiotics can be used in children as appropriate. CRD42019133900.

Antimicrobial resistance and novel mutations detected in the gyrA and parC genes of Pseudomonas aeruginosa strains isolated from companion dogs

BackgroundFluoroquinolone agents, such as enrofloxacin and marbofloxacin, are commonly used for pseudomonal infection in veterinary medicine. However, the rate of resistance to fluoroquinolones is rapidly increasing, according to multiple studies in various countries. Point mutations in the quinolone resistance-determining region (QRDR) are closely related to the increased fluoroquinolone resistance of Pseudomonas aeruginosa. The aim of this study was to investigate current antimicrobial susceptibility and fluoroquinolone resistance in P. aeruginosa strains isolated from dogs. The presence of point mutations in the QRDR was confirmed by gyrA and parC polymerase chain reaction and nucleotide sequencing analysis.ResultsA total of 84 nonduplicated P. aeruginosa strains were obtained from 228 healthy dogs (healthy group) and 260 dogs with clinical signs (infected group). Among these isolates, 38 strains from the healthy group were detected in several sample types, whereas 46 strains from the infected group were obtained mostly from dogs’ ears with otitis externa (41/260, 15.8%). All strains were resistant to nalidixic acid, while some were also resistant to enrofloxacin (23/84, 27.4%), marbofloxacin (17/84, 20.2%), levofloxacin (12/84, 14.3%), or ciprofloxacin (11/84, 13.1%). Enrofloxacin resistance was significantly higher in strains from the infected group than in those from the healthy group (p < 0.05). Among the 23 fluoroquinolone-resistant strains, 8 and 4 different mutations were detected in the gyrA and parC genes, respectively. Mutations in gyrA were significantly common in the infected group (p < 0.05). Hotspots for the gyrA and parC mutations were Thr83 (34.8%, 8/23) and Pro116 (91.3%, 21/23), respectively. Double and triple mutations were also found in 5 of the strains.ConclusionNovel mutations in the gyrA and parC genes were first found in P. aeruginosa isolated from companion dogs in South Korea. These findings suggest that it is important to encourage prudent use of fluoroquinolone antibiotics in canine pseudomonal infection treatment.

FDA collaboration to improve safe use of fluoroquinolone antibiotics: an ex post facto matched control study of targeted short-form messaging and online education served to high prescribers.

Objective:This ex post facto matched control study was conducted to evaluate the effect of targeted short-form messages or continuing medical education (CME) on fluoroquinolone prescribing among high prescribers.Methods:A total of 11,774 Medscape healthcare provider (HCP) members prescribing high volumes of fluoroquinolones were randomized into three segments to receive one of three unique targeted short-form messages, each delivered via email, web alerts, and mobile alerts. Some HCPs receiving targeted short-form messages also participated in CME on fluoroquinolone prescribing. A fourth segment of HCPs participated in CME only. Test HCPs were matched to third-party-provider prescriber data to identify control HCPs. We used prescriber data to determine new prescription volume; percentage (%) of HCPs with reduced prescribing; new prescription volume for acute bacterial sinusitis (ABS), uncomplicated urinary tract infection (uUTI), and acute bacterial exacerbations of chronic bronchitis in those with chronic obstructive pulmonary disease (ABECB-COPD). Open rates for emailed targeted short-form messages were also measured.Results:Targeted short-form messages and CME each resulted in significant new prescription volume reduction versus control. Combining targeted short-form messages with CME yielded the greatest percentage of test HCPs with reduced prescribing (80.1%) versus controls (76.2%; p<0.0001). New prescription volume decreased significantly for uUTI and ABS following exposure to targeted short-form messages, CME, or both. Targeted short-form messages containing comparative prescribing information with or without clinical context were opened at slightly higher rates (10.8% and 10.6%, respectively) than targeted short-form messages containing clinical context alone (9.1%).Conclusions:Targeted short-form messages and CME, alone and in combination, are associated with reduced oral fluoroquinolone prescribing among high prescribers.

TL 18094 - Fluorquinolones and the risk of Achilles tendon disorders

Introduction: Achilles FQ-associated tendinopathy was first reported by Bailey et al. in 1983. Since then, nearly 200 case reports related to FQ-associated tendon injury have been published, as well as some case control and cohort studies. Today, drug-induced tendinopathy is accepted as a class effect of FQ. The Achilles tendon is affected in 90% of cases of FQ-related tendinopathy and rupture. Objective: To evaluate current evidence for the association between fluoroquinolones and Achilles tendinopathy and to identify associated risk factors that increase the incidence of this complication. Methods: We conducted a computerized search of the relevant scientific literature from 1988 to 2018 using electronic databases, including PubMed, Medline and Scopus. The search terms were fluoroquinolone-related tendinopathy. Eligible studies were any available reports of fluoroquinolone-related tendinopathy (tendinitis, tendon pain, or rupture); animal and human histologic studies were included. Data collected included any cases of fluoroquinolone-related tendinopathy, the particular tendon affected, type of FQ, dosage, and concomitant risk factors. Results: The references selected were reviewed by all authors and judged based on their contribution to the body of knowledge on this topic. The conduct and validity of any clinical studies were carefully considered, and the outcomes of management protocols were carefully scrutinized. Case reports mentioning a specific association with the condition that were thought to be relevant to the discussion were included. Only papers that made a significant contribution to understanding of this condition were included in the review. Thus, a total of 560 abstracts were screened, 79 of which were directly related to FQ-associated Achilles tendinopathy or tendon rupture. Conclusion: The association between the use of fluoroquinolone antibiotics and Achilles tendon disorders is well-established in the medical literature. We found that male gender, advanced age, normal BMI, chronic renal failure and concurrent use of corticosteroids increases the risk of Achilles tendon pathology. Caution should be exercised during the utilization of this antibiotic class in patients with these characteristics

Antibiotic side‐effects: from the anticipated to the bizarre

In light of the recent MHRA restrictions on the use of fluoroquinolone antibiotics, this article provides an overview of the adverse reactions associated with all classes of antibiotic ‐ from the most common side‐effects such as gastrointestinal disturbance to rare, idiosyncratic reactions.

2096. System-Wide Multi-Pronged Approach Leads to Successful Reduction of Fluoroquinolone Use Across a Large Health System

BackgroundOveruse of fluoroquinolones has been associated with increased rates of Clostridioides difficile infections, MRSA, and resistant Gram-negative infections due to selective pressure on normal flora. In addition, the FDA has issued several safety alerts regarding systemic use of fluoroquinolone antibiotics due to concerns for serious adverse events and antimicrobial resistance. Considerable variability in the utilization of this antibiotic class across the system resulted in a system-wide initiative to reduce inappropriate prescribing.MethodsA national initiative included the integration of system-wide approved adult criteria for use into electronic health record order sets and pharmacy clinical decision support systems. System-wide education on the initiative involved learning modules, education toolkits and webinars. Fluoroquinolone utilization rates were reported monthly to help facilities determine the success of initiatives to improve performance.ResultsThe fluoroquinolone criteria for use were integrated into several disease-specific order sets system-wide to include: pneumonia, acute exacerbation of COPD, chronic bronchitis, sepsis, acute pyelonephritis, and skin and soft-tissue infection. The learning modules were assigned to all acute care pharmacists resulting in 1,783 completions. Education toolkits were utilized by antimicrobial stewardship teams for provider education. A significant reduction in fluoroquinolone utilization rates, defined by days of therapy (DOT) per 1000 patient-days, was seen across 94 facilities (Figure 1). This resulted in a 45.84% reduction in fluoroquinolone rates from 2017 (56.96, 95% CI 56.72, 57.21) to 2018 (30.85, 95% CI 30.66, 31.04).ConclusionDeveloping and implementing a multi-pronged approach to maximize the effective use of fluoroquinolones can result in significant reductions in utilization across a diverse health system. Disclosures All authors: No reported disclosures.

Demographic Factors Associated with Insertional and Noninsertional Achilles Tendinopathy

Category:SportsIntroduction/Purpose:Achilles tendinopathy is a common clinical entity encountered by orthopaedic surgeons, although the demographics of patients that suffer from this pathology are incompletely understood. It has been suggested that there may be differences in patients that get insertional (IAT) and noninsertional Achilles tendinopathy (NIAT), and our clinical experience has been that older, less active patients tend to get insertional tendinopathy. The goal of this study is to further investigate the features of patients in a single institution who presented with Achilles tendinopathy.Methods:We used ICD-9 and ICD-10 codes to find patients who presented with Achilles tendinopathy to two foot and ankle surgeons at one academic medical center from 2007-2018. We made note of patient characteristics such as age, gender, BMI, medical comorbidities, and level of activity. Physical examination, including the presence of a gastrocnemius equinus, was noted as well. Characteristics of insertional and non-insertional tendinopathy subgroups were compared using Student’s T-tests and chi- squared tests.Results:The characteristics of 948 consecutive patients were analyzed. The mean age was 55 years and 50.5% of the patients were male. Patients with IAT had significantly higher BMIs than did those with NIAT (30.5 compared to 28.0, p < .05). The mean age was 54.5 years in the IAT group compared to 55.8 years in the NIAT group (p>.05). Patients with NIAT self-identified as active a greater percentage of the time (63% vs 45%, p<0.5). 76% of the IAT group had a gastrocnemius equinus on physical examination, compared to 67% of the non-insertional group. Antecedent fluoroquinolone antibiotic use was only reported in 10% of patients, and all of these patients presented with NIAT.Conclusion:The age at which patients present with insertional and noninsertional Achilles tendinopathy is not significantly different, although patients with NIAT had a lower BMI and self-identified as active a greater percentage of the time. A gastrocnemius equinus was present in a high percentage of patients with both IAT and NIAT. Fluoroquinolone use was not involved in most cases, although, when it was, patients presented with NIAT.

Synergistic Effects of Anionic/Cationic Dendrimers and Levofloxacin on Antibacterial Activities.

Despite the numerous studies on dendrimers for biomedical applications, the antibacterial activity of anionic phosphorus dendrimers has not been explored. In our research, we evaluated the antibacterial activity of modified polycationic and polyanionic dendrimers in combination with levofloxacin (LVFX) against Gram-negative (Escherichia coli ATCC 25922, Proteus hauseri ATCC 15442) and Gram-positive (Staphylococcus aureus ATCC 6538) bacteria. In the case of Gram-negative bacteria, we concluded that a combination of dendrimers and antibiotic gave satisfactory results due to a synergistic effect. The use of fluoroquinolone antibiotics, such as LVFX, not only caused resistance in disease-causing microorganisms but also increased environmental pollution. Therefore, reduction of drug dosage is of general interest.

Fluoroquinolone antibiotics: safety of use by the example of ciprofloxacin

Due to repeated reports of adverse effects with the use of fluoroquinolone antibiotics, these drugs become over and over again the object of the close attention of pharmacovigilance specialists and health care specialists. The aim : to study the frequency and the nature of adverse reactions associated with the use of ciprofloxacin, based on the analysis of the spontaneous reports received by the Russian pharmacovigilance service. Materials and Methods : A retrospective analysis of the spontaneous reports of ciprofloxacin was conducted on the data-base «Pharmacovigilance» of the automated information system of Roszdravnadzor from 2008 to 2018. Results : 3403 adverse reactions that occurred in 2083 patients using ciprofloxacin were recorded. The most frequently developed reactions were from skin and subcutaneous tissues (37.3 %), general disorders and disorders at the injection site (21.1 %), gastrointestinal tract reactions (14.9 %). More than a one third of the reports contained information about serious adverse reactions. Unexpected reactions were identified as not recorded in the instructions for the medical use of ciprofloxacin: bradycardia, atrial arrhythmia, cyanosis, increased blood pressure. Conclusions : fluoroquinolone antibiotics with proven efficacy and years of experience in clinical use, continue to be drugs whose safety requires constant monitoring. The results of the study confirmed the possibility of detecting a wide range of the adverse reactions using the method of spontaneous reports. Regulatory authorities of the Russian Federation should recommend to registration certificate holders to include the information of adverse reactions of ciprofloxacin that were registered in the post-marketing period in the instructions for medical use.

Persistence of the Fluoroquinolone Antibiotic Difloxacin in Soil and Lacking Effects on Nitrogen Turnover

The environmental risks caused by the use of fluoroquinolone antibiotics in human therapeutics and animal husbandry are associated with their persistence and (bio)accessibility in soil. To assess these aspects, we administered difloxacin to pigs and applied the contaminated manure to soil. We then evaluated the dissipation and sequestration of difloxacin in soil in the absence and presence of plants within a laboratory trial, a mesocosm trial, and a field trial. A sequential extraction yielded antibiotic fractions of differing binding strength. We also assessed the antibiotic's effects on nitrogen turnover in soil (potential nitrification and denitrification). Difloxacin was hardly (bio)accessible and was very persistent under all conditions studied (dissipation half-life in bulk soil, >217 d), rapidly forming nonextractable residues. Although varying environmental conditions did not affect persistence, dissipation was accelerated in soil surrounding plant roots. Effects on nitrogen turnover were limited due to the compound's strong binding and small (bio)accessibility despite its persistence.

Successful Outcomes with Oral Fluoroquinolones Combined with Rifampicin in the Treatment of Mycobacterium ulcerans: An Observational Cohort Study

BackgroundThe World Health Organization currently recommends combined streptomycin and rifampicin antibiotic treatment as first-line therapy for Mycobacterium ulcerans infections. Alternatives are needed when these are not tolerated or accepted by patients, contraindicated, or neither accessible nor affordable. Despite in vitro effectiveness, clinical evidence for fluoroquinolone antibiotic use against Mycobacterium ulcerans is lacking. We describe outcomes and tolerability of fluoroquinolone-containing antibiotic regimens for Mycobacterium ulcerans in south-eastern Australia.Methodology/Principal FindingsAnalysis was performed of prospectively collected data including all primary Mycobacterium ulcerans infections treated at Barwon Health between 1998 and 2010. Medical treatment involved antibiotic use for more than 7 days; surgical treatment involved surgical excision of a lesion. Treatment success was defined as complete lesion healing without recurrence at 12 months follow-up. A complication was defined as an adverse event attributed to an antibiotic that required its cessation. A total of 133 patients with 137 lesions were studied. Median age was 62 years (range 3–94 years). 47 (34%) had surgical treatment alone, and 90 (66%) had combined surgical and medical treatment. Rifampicin and ciprofloxacin comprised 61% and rifampicin and clarithromycin 23% of first-line antibiotic regimens. 13/47 (30%) treated with surgery alone failed treatment compared to 0/90 (0%) of those treated with combination medical and surgical treatment (p<0.0001). There was no difference in treatment success rate for antibiotic combinations containing a fluoroquinolone (61/61 cases; 100%) compared with those not containing a fluoroquinolone (29/29 cases; 100%). Complication rates were similar between ciprofloxacin and rifampicin (31%) and rifampicin and clarithromycin (33%) regimens (OR 0.89, 95% CI 0.27–2.99). Paradoxical reactions during treatment were observed in 8 (9%) of antibiotic treated cases.ConclusionsAntibiotics combined with surgery may significantly increase treatment success for Mycobacterium ulcerans infections, and fluoroquinolone combined with rifampicin-containing antibiotic regimens can provide an effective and safe oral treatment option.