Moxifloxacin in the treatment of acute bacterial rhinosinusitis: Results of a multicenter, non-interventional study

Zhou, Bing; Jiang, Xuejun; Zhai, Lijie; Xiao, Shuifang; Wang, Jiadong; Xiao, Gensheng; Ruan, Banpu; Liang, Chuanyu; Ye, Qing; Hu, Baohua; Wang, Haibo

doi:10.3109/00016481003629036

Cited by 5 publications

(5 citation statements)

References 5 publications

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“…Many clinical studies have shown the efficacy of moxifloxacin in the treatment of acute maxillary sinusitis (Arrieta et al, 2007;Gehanno et al, 2003;Johnson et al, 2008;Rakkar et al, 2001;Zhou et al, 2010). In our opinion, the microbiological results of this study suggest that clinical trials should be designed to investigate the clinical usefulness of moxifloxacin in the treatment of chronic maxillary sinusitis also.…”

Section: Discussionmentioning

confidence: 91%

Bacteriological findings and antimicrobial resistance in odontogenic and non-odontogenic chronic maxillary sinusitis

Puglisi

Privitera

Maiolino

et al. 2011

Journal of Medical Microbiology

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The main objectives of this study were to estimate the frequency of chronic maxillary sinusitis of dental origin, and to evaluate the microbiology of odontogenic and non-odontogenic chronic maxillary sinusitis. Aspirates from 59 patients with chronic maxillary sinusitis (47 non-odontogenic, 12 odontogenic), collected during a 3-year period, were microbiologically processed for aerobic and anaerobic bacteria. Moreover, antimicrobial susceptibility was evaluated in the isolated bacteria. In this study, 20 % of chronic maxillary sinusitis cases were associated with a dental origin, and sinus lift procedures were the main aetiological factor. Our microbiological findings showed that all specimens from chronic maxillary sinusitis were polymicrobial. Sixty aerobes and 75 anaerobes were recovered from the 47 cases of non-odontogenic sinusitis (2.9 bacteria per specimen); 15 aerobes and 25 anaerobes were isolated from the 12 patients with odontogenic sinusitis (3.3 bacteria per specimen). The predominant aerobes were Staphylococcus aureus (27) and Streptococcus pneumoniae (16), while the more frequent anaerobes were Peptostreptococcus species (31) and Prevotella species (30). Haemophilus influenzae and Moraxella catarrhalis were absent in sinusitis associated with a dental origin. Overall, 22 % of Staphylococcus aureus isolates were oxacillin-resistant, and 75 % of Streptococcus pneumoniae isolates were penicillin-resistant and/or erythromycin-resistant; 21 % of anaerobic Gram-positive bacteria were penicillin-resistant, and 44 % of anaerobic Gram-negative bacteria were blactamase-positive. Vancomycin and quinopristin-dalfopristin had the highest in vitro activity against Staphylococcus aureus and Streptococcus species, respectively; amoxicillin-clavulanate and cefotaxime showed the highest in vitro activity against aerobic Gram-negative bacteria; and moxifloxacin, metronidazole and clindamycin were the most active against anaerobic bacteria.

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Section: Discussionmentioning

confidence: 91%

Bacteriological findings and antimicrobial resistance in odontogenic and non-odontogenic chronic maxillary sinusitis

Puglisi

Privitera

Maiolino

et al. 2011

Journal of Medical Microbiology

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“…[37,40] These data did not show significantly higher toxicity of moxifloxacin compared with commonly used antibiotics if the contraindications and precautions of use mentioned in the Summary of Product Characteristics[41–43] are taken into account. Post-marketing studies[44–53] have confirmed that moxifloxacin is generally well tolerated in medical practice, without new or unanticipated serious adverse events (SAEs) beyond those already established from controlled clinical studies.…”

Section: Introductionmentioning

confidence: 99%

Moxifloxacin Safety

2012

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BackgroundMoxifloxacin, a fluoroquinolone antibiotic, is used for the treatment of respiratory tract, pelvic inflammatory disease, skin, and intra-abdominal infections. Its safety profile is considered favorable in most reviews but has been challenged with respect to rare but potentially fatal toxicities (e.g. hepatic, cardiac, or skin reactions).ObjectiveTo analyze and compare the safety profile of moxifloxacin versus comparators in the entire clinical database of the manufacturer.SettingData on the valid-for-safety population from phase II–IV actively controlled studies (performed between 1996 and 2010) were analyzed. Studies were either double blind (n = 22 369) or open label (n = 7635) and included patients with indications that have been approved in at least one country [acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia, uncomplicated pelvic inflammatory disease, complicated and uncomplicated skin and skin structure infections, and complicated intra-abdominal infections] (n = 27 824) and patients with other indications (n = 2180), using the recommended daily dose (400 mg) and route of administration (oral, intravenous/oral, intravenous only). The analysis included patients at risk (age ≥65 years, diabetes mellitus, renal impairment, hepatic impairment, cardiac disorders, or body mass index <18 kg/m2). Patients with known contraindications were excluded from enrollment by study protocol design, but any patient having entered a study, even if inappropriately, was included in the analysis.Main Outcome MeasureCrude incidences and relative risk estimates (Mantel-Haenszel analysis) of patients with any adverse event (AE), adverse drug reaction (ADR), serious AE (SAE), serious ADR (SADR), treatment discontinuation due to an AE or ADR, and fatal outcomes related to an AE or ADR.ResultsOverall incidence rates of AEs were globally similar in the moxifloxacin and comparator groups. By filtering the data for differences in disfavor of moxifloxacin (i) at ≥2.5% for events with an incidence ≥2.5% or at ≥2-fold for events with an incidence <2.5% in one or both groups and (ii) affecting ≥10 patients in either group, we observed slightly more (i) AEs in double-blind intravenous-only and open-label oral studies, (ii) SAEs in double-blind intravenous-only studies, (iii) ADRs and SADRs in open-label oral studies, (iv) SADRs in open-label intravenous/oral studies, and (v) premature discontinuation due to AEs in open-label intravenous-only studies. The actual numbers of SADRs (in all studies) were small, with clinically relevant differences noted only in intravenous/oral studies and mainly driven by ‘gastrointestinal disorders’ (15 versus 7 patients) and ‘changes observed during investigations’ (23 versus 7 patients [asymptomatic QT prolongation: 11 versus 4 patients in double-blind studies]). Analysis by comparator (including another fluoroquinolone) did not reveal medically relevant differences, even in patients at risk. Incidence rates of hepatic disorders, tendon disorders, clin...

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“…Previous studies have shown that moxifloxacin treatment of acute bacterial rhinosinusitis produces rapid symptom improvement with good tolerability [25], [26], and is at least effective as comparator antibiotics [32]–[35]. Numerous variables may affect the relevance of the results from randomised controlled trials to everyday clinical practice.…”

Section: Discussionmentioning

confidence: 99%

“…The pharmacokinetic and antibacterial characteristics of moxifloxacin support its use in acute bacterial rhinosinusitis [22], [24] and previous studies have shown that treatment with moxifloxacin rapidly improves the signs and symptoms of affected patients [25], [26]. According to several clinical guidelines, this respiratory fluoroquinolone is an appropriate choice of antibiotic in selected cases, such as those with more severe disease, those with a history of β-lactam allergy, where first-line antibiotic treatment has failed, where resistance to first-line antibiotics is suspected or in patients for whom the consequences of treatment failure could be serious [9], [10], [27].…”

Section: Introductionmentioning

confidence: 91%

Characterisation of Patients Receiving Moxifloxacin for Acute Bacterial Rhinosinusitis in Clinical Practice: Results from an International, Observational Cohort Study

et al. 2013

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We conducted a prospective, non-controlled, multi-centre Phase IV observational cohort study of patients with acute bacterial rhinosinusitis who were treated with moxifloxacin in clinical practice in 19 countries in Asia Pacific, Europe and the Middle East. With the data collected we evaluated the presentation and course of the current disease episode, particularly in terms of the principal clinical signs and symptoms of acute rhinosinusitis and diagnostic procedures. A final assessment of moxifloxacin therapy was made to evaluate the impact of the sinusitis episode on activities of daily life and on sleep disturbance, and to evaluate the clinical outcome of treatment. A total of 7,090 patients were enrolled, of whom 3909 (57.6%) were included in the valid for clinical outcome and safety population. Regional differences were observed in the main symptoms of acute rhinosinusitis and, according to several characteristics, disease episodes appeared to be more severe in patients in Europe than in the Asia Pacific or Middle East regions. The sinusitis episode impacted on daily living for mean (SD) periods of 3.6 (3.2), 4.6 (3.9) and 3.1 (3.0) days and disturbed sleep for 3.6 (3.2), 4.6 (3.9) and 3.1 (3.0) nights in the Asia Pacific, Europe and Middle East regions, respectively. With moxifloxacin treatment, the mean (SD) time to improvement of symptoms was 3.0 (1.5), 3.4 (1.6) and 3.2 (1.5) days, and the time to resolution of symptoms was 4.8 (2.6) days, 5.7 (2.4) days and 5.5 (2.5) days, in the Asia Pacific, Europe and Middle East regions, respectively. In conclusion, acute rhinosinusitis remains a substantial health burden with significant impact on patients’ quality of life, and there are differences between global regions in the clinical presentation, diagnosis and clinical course of disease episodes. Moxifloxacin was an effective and well-tolerated treatment option in the overall population. Registration: ClinicalTrials.gov Identifier: NCT00930488

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Moxifloxacin in the treatment of acute bacterial rhinosinusitis: Results of a multicenter, non-interventional study

Cited by 5 publications

References 5 publications

Bacteriological findings and antimicrobial resistance in odontogenic and non-odontogenic chronic maxillary sinusitis

Bacteriological findings and antimicrobial resistance in odontogenic and non-odontogenic chronic maxillary sinusitis

Moxifloxacin Safety

Characterisation of Patients Receiving Moxifloxacin for Acute Bacterial Rhinosinusitis in Clinical Practice: Results from an International, Observational Cohort Study

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