PID5: moxifloxacin vs amoxicillin/clavulanate in the treatment of acute maxillary sinusitis (AMS): efficacy, safety and patient-reported outcomes in primary care
Abstract
OBJECTIVE: This study was designed to reflect real-world experience in the treatment of patients with AMS. Efficacy, safety, and patient-reported outcomes variables were compared between moxifloxacin (MXF) and amoxicillin/clavulanate (AC) for the management of AMS in a primary care setting. METHODS: In this prospective, multicenter, non-blinded phase IIIb trial, 475 adult patients with symptoms of AMS were randomized to receive a 10-day oral regimen of either MXF (400mg once-daily) or AC (875mg twice-daily). Clinical success at the test-of-cure (TOC) visit (post-therapy days 14–21) was the primary efficacy measure. Secondary outcomes included rate of clinical relapse at follow-up (post-therapy days 26–46) and exploratory evaluation of patient-reported outcomes variables. Safety data was also tabulated from intent-to-treat (ITT) patients. RESULTS: Of 471 adults comprising the ITT population (234 MXF, 237 AC), MXF treatment was statistically equivalent to AC at the TOC visit (85.2% vs 81.8%; 95%CI = −6%,13%). Per-protocol analysis also confirmed statistical equivalence between MXF and AC (86.5% vs 83.6%; 95%CI = −7%,13%). Rates of relapse were similar for the ITT (4% MXF, 5% AC) and the per-protocol (4% both) populations. The frequency of drug-related adverse events were similar between MXF (30%) and AC (25%) and were primarily gastrointestinal-related: nausea (11% MXF, 5% AC) and diarrhea (3% MXF, 10% AC). At the TOC visit, significantly more MXF-treated patients (n = 47;…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 475 participants or records.
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