Treatment Of Acute Bacterial Sinusitis Research Articles

Modern pharmacotherapy of acute bacterial sinusitis: results of an open randomized clinical trial of the therapeutic equivalence of Cefixime EXPRESS and Suprax Solutab

Acute bacterial sinusitis is one of the most common causes of prescribing systemic antibacterial drugs in otorhinolaryngology. With bacterial etiology of the disease, beta-lactam antibiotics are prescribed, in particular cefixim. Cefixim in the form of dispersible tablets has high clinical and bacteriological efficiency, as well as good tolerability in patients with acute sinusitis. To study the therapeutic equivalence of two drugs of cefixim (reproduced drug Cefixim Express and reference drug Suprax Solutab) in patients with acute bacterial sinusitis. 60 adult patients with a diagnosis of acute bacterial sinusitis took part in a randomized open comparative clinical study. Patients of group 1 (n=30) received the drug Cefixim Express in the form of dispersible tablets 400 mg once a day. Group 2 (n=30) received Suprax Solutab in the form of dispersible tablets 400 mg once a day. The duration of treatment course was 7 days. All patients conducted general clinical and otorhinolaryngological examinations, assessment of symptoms of acute sinusitis, assessment of the general clinical impression of the therapy, tolerance of treatment, analysis of the frequency of unwanted phenomena before treatment, 3 days after the beginning of therapy and after the course completion (7 days). Recovery occurred in 63.3% of patients in group 1 according to the inspection on the 7th day of treatment and in 66.67% of patients in group 2. The rate of clinical symptoms regression by the end of therapy was comparable in the comparison groups. Hyperemia of the nasal mucosa, purulent nasal discharge and difficulty in nasal breathing (p<0.01) regressed by the 7th day in patients of both treatment groups. The incidence of adverse reactions on the 7th day of treatment in group 1 was 10%, in group 2 - 6.7% (p>0.05). The drug Cefixim Express has high therapeutic effectiveness in the treatment of acute bacterial sinusitis, comparable to Suprax Solutab. Cefixime EXPRESS has demonstrated a good tolerability and a favorable safety profile.

Do Oral Challenges Alter Prescribing Practices? A MarketScan Study Evaluating Use of First-Line Antibiotics for Sinus Infections

Patients with drug allergy labels have increased length of hospitalizations, healthcare costs, multidrug-resistant organisms, and surgical site infections. Oral challenges can be used to remove drug allergy labels in patients that are not truly allergic or that have outgrown their allergy. No prior studies to our knowledge have evaluated the effects of challenges on prescribing practices. We aimed to determine the effect of oral challenges on use of beta-lactam antibiotics, which are the first-line antibiotics for treatment of acute bacterial sinusitis.

The use of fluoroquinolones and macrolides for sinusitis: a retrospective cross-sectional study

β-Lactam antibiotics are the recommended first-line treatment for acute bacterial sinusitis. Fluoroquinolones are recommended in patients with hypersensitivity reactions to penicillins, and macrolide antibiotics are no longer recommended. The objectives of this study were to understand whether outpatient antibiotic prescribing practices adhere to treatment guidelines and to describe rates of fluoroquinolone and macrolide antibiotic prescribing for the treatment of sinusitis. This was a retrospective cross-sectional study using US National Ambulatory Medical Care Survey (NAMCS) data. The prevalence of antibiotic prescribing for sinusitis was estimated, and the antibiotic prescribing pattern was measured. Additionally, significant factors associated with various antibiotic prescribing during the visits related to sinusitis were identified. Among physician visits related to sinusitis from 2013 to 2016 (n = 2739), 66.4% involved antibiotic prescribing. Visits with antibiotic prescribing showed greater proportions of patients aged < 18 years (21.7 vs 11.1%, p < 0.001), patients reporting fever (79.8 vs 50.7%, p < 0.001), and patients seeing family physicians or internal medicine specialists (68.4 vs 44.8%, p < 0.001) than those without antibiotic prescribing. Penicillins, macrolides, cephalosporins, and fluoroquinolones were prescribed in 42.2%, 30.6%, 15.2%, and 9.5% of the visits involving antibiotic prescribing for sinusitis, respectively. The odds of fluoroquinolone/macrolide prescribing were reduced by 73% if patients visited pediatricians and by 59% with otolaryngologists. Macrolides were the most common inappropriate antibiotic class prescribed for sinusitis. This study identifies a need for more focused attention to improve prescribing for sinusitis and adherence to the treatment guidelines.

Sinusitis in Children.

Acute bacterial sinusitis (ABS) mostly occurs as a complication of acute viral upper respiratory tract infection (URI), which is a common condition encountered in an outpatient setting. ABS manifests with three different presentations, most commonly as persistent symptoms of viral URI (nasal drainage and or cough) for more than 10 days. ABS is also diagnosed when the patient presents with severe symptoms of a URI accompanied by fever >102.2°F and purulent nasal drainage for at least 3 days. Lastly, ABS can complicate viral URI around day 6 or 7 of illness after initial improvement in the symptoms of URI. Imaging studies are not recommended for diagnosing ABS, unless intracranial or orbital complications are suspected. Signs of proptosis, restriction of eye movements, ophthalmoplegia, and visual impairment are very specific for orbital involvement. Treatment of ABS with antibiotics is recommended based on the clinical scenario and has been shown to have higher cure rates as compared to placebo. [Pediatr Ann. 2018;47(10):e396-e401.].

Effect of Ceftriaxone versus Amoxicillin + Clavulanic Acid for Treatment of Acute Bacterial Rhino Sinusitis: Short Course Therapy

BACKGROUND:Acute bacterial rhinosinusitis is one of upper respiratory tract infection that disturbs patient life and requires special consideration.AIM:To evaluate the efficiency of Ceftriaxone versus a high dose of Amoxicillin-clavulanic acid for the treatment of acute bacterial rhinosinusitis.PATIENTS AND METHOD:Observational retrospective study include120 patients of both sex classified into two groups equally conducted. G1 treated with Ceftriaxone 1 g intramuscular injection once daily while, G2 treated with oral Amoxicillin-clavulanic acid (875 mg/125 mg) twice daily for 3-4 days then, the outcome of treatment evaluated as a cure or failed at the fifth or fourth day of treatment.RESULTS:Significant cure response observed in Ceftriaxone treated patient’s P ≤ 0.05 and significant failure response observed in Amoxicillin-clavulanic acid-treated patients when groups compared with each other. About gender and age groups, no significant differences in number between group 1 and 2 P ≥ 0.05.CONCLUSION:Ceftriaxone found more effective in the treatment of acute bacterial sinusitis than Amoxicillin+ clavulanic acid. Amoxicillin+clavulanic acid associated with more male failure cases recorded than female.

NICHE OF THIRD GENERATION CEPHALOSPORINS IN TREATMENT OF ACUTE BACTERIAL UPPER RESPIRATORY TRACT AND EAR INFECTIONS

The vast majority of acute respiratory infections have a viral etiology. Streptococcus pneumoniae, Hemophilus influenza and Moraxella catarrhalis are the major bacterial pathogens responsible for the development of acute sinusitis and acute otitis media. The article presents clinical signs of bacterial paranasal sinuses and ear infections and indications for systemic antibacterial therapy. The issues of choice of antibacterial drugs for the treatment of acute bacterial sinusitis and acute otitis media are reviewed. The niche of third generation cephalosporins in the treatment of this pathology is also examined in this article. The article provides an overview of clinical trials of the efficacy and safety of cefixime in patients with URT and ear diseases.

The clinical effectiveness of azithromycin antimicrobial therapy used for the treatment of acute bacterial sinusitis in the patients presenting with concomitant pathology

The objective of the present publication was to report the result of the evaluation of the clinical effectiveness of azithromycin (Sumamed) antimicrobial therapy used for the treatment of bacterial acute rhinsinusitis (ARS) in the patients presenting with concomitant pathology of the respiratory and cardiovascular systems. Dynamics of the reversal of the clinical symptoms of bacterial ARS in the patients of the study group is described. Neither adverse side effects nor complications in response to the treatment were documented. 98.6% of the patients recovered from the disease within 7 days after the onset of the treatment. It is concluded that antimicrobial therapy with the use of azithromycin (Sumamed) based at the outpatient settings provides a highly efficient tool for the treatment of the patients presenting with concomitant pathology of the respiratory and cardiovascular systems

The clinical effectiveness of azithromycin antimicrobial therapy used for the treatment of acute bacterial sinusitis in the patients presenting with concomitant pathology

The objective of the present publication was to report the result of the evaluation of the clinical effectiveness of azithromycin (Sumamed) antimicrobial therapy used for the treatment of bacterial acute rhinsinusitis (ARS) in the patients presenting with concomitant pathology of the respiratory and cardiovascular systems. Dynamics of the reversal of the clinical symptoms of bacterial ARS in the patients of the study group is described. Neither adverse side effects nor complications in response to the treatment were documented. 98.6% of the patients recovered from the disease within 7 days after the onset of the treatment. It is concluded that antimicrobial therapy with the use of azithromycin (Sumamed) based at the outpatient settings provides a highly efficient tool for the treatment of the patients presenting with concomitant pathology of the respiratory and cardiovascular systems.

Clinical Practice Guideline for the Diagnosis and Management of Acute Bacterial Sinusitis in Children Aged 1 to 18 Years

To update the American Academy of Pediatrics clinical practice guideline regarding the diagnosis and management of acute bacterial sinusitis in children and adolescents. Analysis of the medical literature published since the last version of the guideline (2001). The diagnosis of acute bacterial sinusitis is made when a child with an acute upper respiratory tract infection (URI) presents with (1) persistent illness (nasal discharge [of any quality] or daytime cough or both lasting more than 10 days without improvement), (2) a worsening course (worsening or new onset of nasal discharge, daytime cough, or fever after initial improvement), or (3) severe onset (concurrent fever[temperature ≥39°C/102.2°F] and purulent nasal discharge for at least 3 consecutive days). Clinicians should not obtain imaging studies of any kind to distinguish acute bacterial sinusitis from viral URI, because they do not contribute to the diagnosis; however, a contrast-enhanced computed tomography scan of the paranasal sinuses should be obtained whenever a child is suspected of having orbital or central nervous system complications. The clinician should prescribe antibiotic therapy for acute bacterial sinusitis in children with severe onset or worsening course. The clinician should either prescribe antibiotic therapy or offer additional observation for 3 days to children with persistent illness. Amoxicillin with or without clavulanate is the firstline treatment of acute bacterial sinusitis. Clinicians should reassess initial management if there is either a caregiver report of worsening(progression of initial signs/symptoms or appearance of new signs/symptoms) or failure to improve within 72 hours of initial management.If the diagnosis of acute bacterial sinusitis is confirmed in a child with worsening symptoms or failure to improve, then clinicians may change the antibiotic therapy for the child initially managed with antibiotic or initiate antibiotic treatment of the child initially managed with observation. Changes in this revision include the addition of a clinical presentation designated as “worsening course,” an option to treat immediately or observe children with persistent symptoms for 3 days before treating, and a review of evidence indicating that imaging is not necessary in children with uncomplicated acute bacterial sinusitis.

Psychometric Evaluation of the Sinonasal Outcome Test‐16 and Activity Impairment Assessment in Acute Bacterial Sinusitis

To validate the Sinonasal Outcome Test-16 and Activity Impairment Assessment in patients with acute bacterial sinusitis. Data were used from a phase III clinical trial designed to evaluate the efficacy and safety of moxifloxacin 400 mg once daily for 5 consecutive days in the treatment of acute bacterial sinusitis. The psychometric properties and factor structure of the 2 measures were assessed. Participants were given the measures to self-complete using either a telephone voice response system or a paper-and-pencil format. Three hundred seventy-four patients with acute bacterial sinusitis were used in the analysis. Patients received either a placebo or 400 mg moxifloxacin once daily. Patients were then reviewed at test of cure and follow-up. All analyses were conducted on a combined sample of placebo and active treatment patients. The Sinonasal Outcome Test-16 was associated with minimal missing data at baseline but a higher proportion by test of cure. There was no evidence of floor or ceiling effects and no significant skew. The Activity Impairment Assessment also had low missing data at baseline and no obvious floor or ceiling effects, but the data were not normally distributed. Both measures had good internal consistency. Convergent and divergent validity as well as sensitivity and the minimally important difference are also reported. The measures both have good psychometric properties and are suitable for use with patients with acute bacterial sinusitis. Both instruments are sensitive. The minimal important difference estimates for the Sinonasal Outcome Test-16 are quite high but are similar to estimates reported previously.

El papel de la antibioterapia en la sinusitis aguda: revisión sistemática y metaanálisis

Introduction The aim of this systematic review is to assess whether antibacterial agents are more effective than either placebo or no intervention at all in the treatment of acute bacterial sinusitis. Patients and methods We reviewed the databases and search engines: PubMed, EMBASE, Cochrane Central Register of Controlled Trials and Google Scholar to identify randomized clinical trials (RCTs) in children comparing antibiotics versus placebo. Sinusitis was considered as the persistence of clinically compatible symptoms for at least 10 days. The methodological quality was assessed using the Jadad scale. Four RCTs were selected. We studied the following variables: cure, clinical improvement (on days 10 to 14), relapse-recurrence (from day 14 to day 60) and presence of adverse effects. The results were combined using meta-analysis. We used the fixed effects model or random model depending on whether or not there was heterogeneity. We estimated the combined relative risk (RR) and 95% confidence interval. Results Only two RCTs had a Jadad scale score ≥3. Variable cure-improvement (4 RCTs): RR 1.11 (95% CI: 0.9 to 1.3). Variable relapse-recurrence (3 RCTs): RR 0.9 (95% CI: 0.6 to 1.5). Adverse effects (4 RCTs): 2.01 (95% CI 1.1 to 3.8). Conclusions In children with acute sinusitis, antibacterial agents at the studied doses did not appear to provide benefit in terms of cure and improvement, assessed at 10 to 14 days of follow up. Similarly, the percentage of relapse-recurrence was not lower among children who received antibiotics. Antibiotics are associated more frequently with adverse effects.

Effectiveness of Amoxicillin/Clavulanate Potassium in the Treatment of Acute Bacterial Sinusitis in Children

Effectiveness of Amoxicillin/Clavulanate Potassium in the Treatment of Acute Bacterial Sinusitis in Children

Effectiveness of antibiotics for acute sinusitis in real‐life medical practice

Determining bacterial aetiology of acute sinusitis is difficult without employing invasive procedures. Most episodes of acute sinusitis resolve spontaneously. Antibiotics have demonstrated efficacy for the treatment of acute bacterial sinusitis in clinical trials yet little is known of their effectiveness in real-life treatment settings. Most cases of untreated acute sinusitis resolved spontaneously. Antibiotics were more effective when given within the first 10 days of treatment. This had no effect on later recurrence. Patients with poor oro-dental condition or recent antibiotic use may derive the most benefit from an antibiotic prescription and this should be considered by prescribers. The antibiotics used were found to be equally effective. Existing recommendations to identify acute sinusitis with high probability of bacterial origin, such as the French recommendations, fever or duration of symptoms fail to identify patients in whom antibiotics are more effective. To assess the effectiveness of antibiotics in acute bacterial sinusitis. This was a prospective cohort study with 2 months follow-up of 5640 patients with acute sinusitis included by a random sample from 1174 GPs and 120 ENT specialists. Main outcomes were short-term initial success, defined as the absence of prescription of (another) antibiotic or sinus lavage within 10 days, and lack of recurrence between the 11th and 60th day, after initial success. Initial success was found in 88.7% (95% CI 85.1, 91.4%) of patients without antibiotic prescription at inclusion and 96.2% (95% CI 95.7, 96.7%) of patients prescribed antibiotics. The 10 day adjusted hazard ratio (HR) for treatment failure (new antibiotic prescription or sinus drainage) with initial antibiotics compared with no antibiotics was 0.30 (95% CI 0.21, 0.42) with no difference between antibiotics. Antibiotics were more effective in patients with poor oro-dental condition (HR 0.04, 95% CI 0.01, 0.20) and in patients who had already used antibiotics during the previous 2 months (HR 0.09, 95% CI 0.03, 0.28). For patients without failure at 10 days, recurrence between the 11th and 60th day was similar whether or not they had initially been prescribed an antibiotic, 94.1% (95% CI 93.4, 94.7%) and 93.4% (95%CI 90.3, 95.5%), respectively. Most acute sinusitis cases not prescribed antibiotics resolve spontaneously. Antibiotics reduced by 3.3-fold the risk of failure within 10 days, without impact on later recurrence. The greatest benefit of antibiotics was found for patients with poor oro-dental condition or with antibiotic use within the previous 2 months.

Amoxicillin/potassium clavulanate is effective treatment for acute bacterial sinusitis in children

Amoxicillin/potassium clavulanate is effective treatment for acute bacterial sinusitis in children

Effectiveness of Amoxicillin/Clavulanate Potassium in the Treatment of Acute Bacterial Sinusitis in Children

The role of antibiotic therapy in managing acute bacterial sinusitis (ABS) in children is controversial. The purpose of this study was to determine the effectiveness of high-dose amoxicillin/potassium clavulanate in the treatment of children diagnosed with ABS. This was a randomized, double-blind, placebo-controlled study. Children 1 to 10 years of age with a clinical presentation compatible with ABS were eligible for participation. Patients were stratified according to age (<6 or >or=6 years) and clinical severity and randomly assigned to receive either amoxicillin (90 mg/kg) with potassium clavulanate (6.4 mg/kg) or placebo. A symptom survey was performed on days 0, 1, 2, 3, 5, 7, 10, 20, and 30. Patients were examined on day 14. Children's conditions were rated as cured, improved, or failed according to scoring rules. Two thousand one hundred thirty-five children with respiratory complaints were screened for enrollment; 139 (6.5%) had ABS. Fifty-eight patients were enrolled, and 56 were randomly assigned. The mean age was 66 +/- 30 months. Fifty (89%) patients presented with persistent symptoms, and 6 (11%) presented with nonpersistent symptoms. In 24 (43%) children, the illness was classified as mild, whereas in the remaining 32 (57%) children it was severe. Of the 28 children who received the antibiotic, 14 (50%) were cured, 4 (14%) were improved, 4 (14%) experienced treatment failure, and 6 (21%) withdrew. Of the 28 children who received placebo, 4 (14%) were cured, 5 (18%) improved, and 19 (68%) experienced treatment failure. Children receiving the antibiotic were more likely to be cured (50% vs 14%) and less likely to have treatment failure (14% vs 68%) than children receiving the placebo. ABS is a common complication of viral upper respiratory infections. Amoxicillin/potassium clavulanate results in significantly more cures and fewer failures than placebo, according to parental report of time to resolution of clinical symptoms.

Effectiveness and safety of short vs. long duration of antibiotic therapy for acute bacterial sinusitis: a meta‐analysis of randomized trials

Treatment guidelines generally support that a 10-14-day antibiotic regimen should be administered to uncomplicated acute bacterial sinusitis patients. However, the level of evidence for such a recommendation is rather weak. Treatment of such duration may have disadvantages compared with a shorter duration but equally effective regimen, including the promotion of bacterial drug resistance, poorest patient compliance, higher toxicity, and a greater overall economic burden. The findings of this meta-analysis suggest that short-course antibiotic treatment has similar effectiveness to longer-course treatment for patients with acute uncomplicated bacterial sinusitis, when treatment is warranted. However, we should underscore the importance of the clinician's own assessment, so that antimicrobial therapy should not inappropriately be curtailed in a patient not adequately responding to the regimen administered. We sought to evaluate the effectiveness and safety of short-course antibiotic treatment for acute bacterial sinusitis (ABS) compared with longer duration treatment. We performed a meta-analysis of randomized controlled trials (RCTs), identified by searching PubMed and the Cochrane Central Register of Controlled Trials. We included RCTs that compared short-course (up to 7 days) vs. long-course therapy (> or =2 days longer than short-course), with the same antimicrobial agent, in the same daily dosage, for patients with ABS. Twelve RCTs (10 double-blinded) involving adult patients with radiologically confirmed ABS were included. There was no difference in the comparison of short-course (3-7 days) with long-course treatment (6-10 days) regarding clinical success [12 RCTs, 4430 patients, fixed effect model (FEM), odds ratio (OR) 0.95, 95% confidence interval (CI) 0.81, 1.12]; microbiological efficacy; relapses; adverse events (10 RCTs, 4172 patients, random effects model, OR 0.88, 95% CI 0.71, 1.09); or withdrawals due to adverse events. In the sensitivity analysis comparing 5- vs. 10-day regimens, clinical success was similar, although adverse events were fewer with short-course treatment (5 RCTs, 2151 patients, FEM, OR 0.79, 95% CI 0.63, 0.98). Although antibiotics for acute sinusitis should be reserved for select patients with substantial probability of bacterial disease, accurate clinical diagnosis is often difficult to attain. Short-course antibiotic treatment had comparable effectiveness to a longer course of therapy for ABS. Shortened treatment, particularly for patients without severe disease and complicating factors, might lead to fewer adverse events, better patient compliance, lower rates of resistance development and fewer costs.

Safety Profile of the Respiratory Fluoroquinolone Moxifloxacin

Moxifloxacin, a fluoroquinolone with potent activity against respiratory pathogens, is approved and considered as an alternative to beta-lactams and macrolides for the treatment of acute bacterial sinusitis and lower respiratory tract infections. In this review, we critically examine its safety profile in comparison with other fluoroquinolones and other antibacterial classes sharing similar indications. Data were extracted from published clinical trials, meta-analyses, postmarketing studies, spontaneous report systems and case reports for rare effects. Global analysis did not reveal significantly higher incidences of drug-related adverse effects than for comparators. Tendon rupture was infrequent with moxifloxacin, including when used in elderly patients with chronic obstructive pulmonary disease. Severe toxic cutaneous reactions and allergies were very rare. Phototoxicity and CNS adverse effects were less common than with other fluoroquinolones. Although causing a 4-7 msec corrected QT interval prolongation, severe cardiac toxicity was neither seen in large cohorts or clinical trials nor reported to pharmacovigilance systems. Hepatotoxicity was not different from what was observed for other fluoroquinolones (excluding trovafloxacin) and less frequent than reported for amoxicillin-clavulanic acid or telithromycin. The data show that using moxifloxacin, in its accepted indications and following the corresponding guidelines, should not be associated with an excessive incidence of drug-related adverse reactions, provided the clinician takes care in identifying patients with known risk factors and pays due attention to the contraindications and warnings mentioned in the labelling.

Moxifloxacin induced fatal hepatotoxicity in a 72-year-old man: a case report

Moxifloxacin is a newer-generation synthetic fluoroquinolone that is used for treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community acquired pneumonia, intra-abdominal infections and skin/skin structure infections. We describe a case of fatal hepatotoxicity caused by Moxifloxacin in a 72-year-old man. He presented with jaundice and epigastric tenderness that started one week after being treated for acute exacerbation of his chronic bronchitis with Moxifloxacin by his primary care physician. He was admitted to intensive care unit for close monitoring. His labs showed marked elevation in liver enzymes and bilirubin. His condition continued to deteriorate in intensive care unit despite supportive care. Acute hepatic failure which resulted in his death was attributed to idiosyncratic reaction to Moxifloxacin.

Gemifloxacin: A new treatment option in acute bacterial sinusitis

Treatment choices for acute bacterial sinusitis (ABS) are challenging and undeniably controversial. Current guidelines reflect the impact of bacterial resistance and therefore differ between, and within countries. β-lactams, macrolides and cephalosporins are widely used, although more potent alternatives are still needed. A new fluoroquinolone gemifloxacin, a new potent fluoroquinolone, exhibits excellent activity against the key ABS pathogens Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. In clinical studies, gemifloxacin has been highly effective in the short course treatment of adults with ABS and has been generally well-tolerated. Treatment of ABS with 320 mg gemifloxacin once daily for seven days is as effective as 250 mg cefuroxime axetil twice daily or 200 mg trovafloxacin once daily for 10 days. Furthermore, treatment with once daily gemifloxacin for five days was as effective as treatment for seven days. Of particular note has been the demonstrated success of 5-day treatment against ABS patients with risk factors such as allergic rhinitis, asthma and acute exacerbation of chronic bronchitis. Gemifloxacin is a promising new agent for short-course treatment of inflammation of the sinuses caused by a bacterial infection which over time could lower associated health costs and patient morbidity, increase patient compliance and reduce the potential for resistance development. Le traitement de choix dans la sinusite aiguë bactérienne (SAB) est un défi, incontestablement controversé. Les recommandations officielles reflètent la question de la résistance qui varie selon les pays. Les β-lactamines, macrolides, céphalosporines sont largement utilisées mais des alternatives thérapeutiques doivent être disponibles. La gémifloxacine est une nouvelle fluoroquinolone, efficace, témoignant d’une excellente activité vis-à-vis des pathogènes les plus fréquents dans les SAB, tels que Sreptococcus pneumoniae, Haemophilus influenzae et Moraxella catarrhalis. Dans les études cliniques, la gémifloxacine a été efficace en traitement court chez l’adulte présentant une sinusite bactérienne aiguë et a été généralement bien tolérée. Le traitement à 320 mg de gémofloxacine en dose quotidienne unique en sept jours a été aussi efficace que 250 mg de cefuroxime-axetil deux fois par jour ou 200 mg de trovafloxacine dose unique par jour pendant dix jours. De plus un traitement de gémifloxacine (dose unique) pendant cinq jours a été aussi efficace qu’un traitement de sept jours. Il est à noter tout particulièrement le succès d’un traitement de cinq jours chez des patients atteints de sinusite aiguë bactérienne avec des facteurs de risque tels que rhinite allergique, asthme, exacerbations aiguës de bronchite chronique. La gémifloxacine est donc un nouveau produit prometteur pour le traitement court de l’inflammation associée aux sinusites bactériennes, ce qui à terme pourrait s’accompagner d’une diminution des coûts de santé et de la morbidité, augmenter l’observance du patient et réduire le développement potentiel de la résistance.

Clinical efficacy and time to symptom resolution of 5-day telithromycin versus 10-day amoxicillin–clavulanate in the treatment of acute bacterial sinusitis

ABSTRACTObjective: This study compared the clinical efficacy, time to symptom resolution, and tolerability of a 5-day regimen of telithromycin with a 10-day regimen of high-dose amoxicillin–clavulanate in acute bacterial sinusitis (ABS).Research design and methods: In this multinational (41 centers in Canada, Germany, Greece, Portugal, and Turkey), open-label, noninferiority study, patients ≥18 years old (n = 298) with a clinical ( > 7 days' symptoms) and radiological (air/fluid level, total opacification, mucosal thickening ≥10 mm) diagnosis of ABS were randomized to receive telithromycin 800 mg once daily for 5 days or amoxicillin–clavulanate 875/125 mg twice daily for 10 days. Clinical efficacy and tolerability were assessed at the test-of-cure visit (days 17–21). Time to symptom resolution was based on patients' daily diary assessment of individual symptoms.Results: The per-protocol clinical success rate (primary endpoint) with telithromycin (88.6 % (109/123)) was noninferior to that with amoxicillin–clavulanate (88.8 % (111/125)) (95 % confidence interval: –8.9 to 8.5). In the modified intention-to-treat (mITT) population, the median time for 50 % reduction of total symptom scores was significantly shorter for telithromycin (4 days) vs. amoxicillin–clavulanate (5 days; p = 0.044); median times for 75 % reduction of total symptom scores were: telithromycin, 7 days; amoxicillin–clavulanate, 8 days (p = 0.115). The median time for reduction of total symptom scores to the absent/very mild category (mITT population) was 6 days for telithromycin vs. 8 days for amoxicillin–clavulanate (p = 0.04). All treatment-emergent adverse events (TEAEs) were mostly gastrointestinal and occurred in 20.7 % (30/145) of telithromycin-treated patients vs. 31.8 % (47/148) of amoxicillin–clavulanate-treated patients (p = 0.034). One serious AE was reported in the telithromycin group, but it was considered not to be related to treatment.Conclusions: This open-label, randomized study demonstrated that treatment of ABS with telithromycin resulted in comparable clinical efficacy, shorter times to symptom resolution, and fewer total TEAEs than treatment with amoxicillin–clavulanate.