The Efficacy and Safety of Omadacycline plus β-Lactam versus Moxifloxacin plus β-Lactam for the treatment of Severe Community-Acquired Pneumonia: A Multicenter, Prospective, Randomized Controlled Trial
Abstract
Abstract Background: Severe community-acquired pneumonia (sCAP) is associated with high morbidity and mortality. Current empirical antimicrobial regimens are increasingly challenged by rising antimicrobial resistance and safety concerns (e.g., fluoroquinolone-related adverse events). Omadacycline, a novel aminomethylcycline antibiotic, exhibits broad-spectrum activity against common respiratory pathogens (including drug-resistant strains) and a favorable safety profile. However, its efficacy and safety when combined with β-lactams for the treatment of sCAP remain insufficiently explored.
Methods:: This is a multicenter, prospective, randomized, open-label, active-controlled, non-inferiority trial conducted across 8 tertiary hospitals in China. Eligible participants are adult patients (≥18 years old) who meet the IDSA/ATS 2019 diagnostic criteria for sCAP, with no contraindications to the study drugs (omadacycline, β-lactams, or moxifloxacin) and able to complete follow-up. A total of 248 patients will be recruited and randomized in a 1:1 allocation ratio to either of the two arms. The experimental arm will receive omadacycline (200mg iv once daily for the first day , then 100mg iv q24h) plus β-lactam therapy (piperacillin-tazobactam 4.5g iv q8h or meropenem 1g iv q8h). The control arm will receive moxifloxacin (400mg iv q24h) plus the same β-lactam regimen. The treatment duration for both groups will be 7–14 days, adjusted based on clinical response. The primary endpoint is…
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: 248 participants or records.
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