Moxifloxacin vs amoxicillin/clavulanate in the treatment of acute sinusitis

Arrieta, José; Galgano, Alejandro S.; Sakano, Eulália; Fonseca, Ximena; Amábile-Cuevas, Carlos F.; Hernández-Oliva, Gerardo; Vivar, Raúl; González, Gerardo; Torres, Arturo Manuel Fraile

doi:10.1016/j.amjoto.2006.06.016

Cited by 19 publications

(13 citation statements)

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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%

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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Section: Discussionmentioning

confidence: 99%

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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“…In all of the 5 trials that assessed the bacteriologic efficacy of the treatments, 21,23,26,29,31 bacteriologic success for patients with no clinical manifestation of persistent infection corresponded mainly to presumed rather than microbiologically documented eradication of the pathogens that had been isolated before treatment. As for the methods used for bacteriologic sampling, specimens for culture were obtained exclusively by sinus puncture and aspiration in 2 trials; 21,29 in the remaining 3 trials, sinus puncture was just one of the methods used, along with aspiration from the middle meatus or endoscopic sampling.…”

Section: Evaluation Of Outcomesmentioning

confidence: 99%

“…For example, in 6 of the 11 trials, the resolution of signs and symptoms of acute sinusitis had to be accompanied by resolution of the radiographic findings. [21][22][23][27][28][29] Two of the studies provided no data on the combined outcome of cure or improvement but did report data on the complete resolution of signs and symptoms. 21,31 Despite these differences, we entered all available relevant data in the analysis of the primary outcome.…”

Section: Evaluation Of Outcomesmentioning

confidence: 99%

“…Two additional trials eligible for inclusion were detected after a secondary search on the Scopus database, but no additional trials were identified in the Cochrane Central Register of Controlled Trials. A total of 11 trials [21][22][23][24][25][26][27][28][29][30][31] were included in the meta-analysis ( Figure 1). The 2 reviewers independently reached the same conclusions regarding studies to be included.…”

Section: Selected Trialsmentioning

confidence: 99%

“…Although serious complications of sinusitis are rare among patients who receive appropriate treatment, 13 the lack of such complications in the populations evaluated in this metaanalysis could be attributed to the fact that patients with a greater likelihood of a complicated course of disease (e.g., those with a history of chronic sinusitis or recurrent acute sinusitis) were excluded from a considerable number of the trials, 21,25,26,[28][29][30]34 even though they are frequently encountered in routine clinical practice. In addition, in all but one of the included studies, 25 the duration of follow-up was limited to no more than 1 month after the end of therapy, which may have been inadequate for accurate estimation of the rates of recurrence and progression to chronic sinusitis.…”

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confidence: 99%

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