The efficacy and safety of omadacycline plus β-lactam versus moxifloxacin plus β-lactam for the treatment of severe community-acquired pneumonia: study protocol of a multicenter, prospective, randomized controlled non-inferiority trial
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, has demonstrated broad-spectrum activity against common respiratory pathogens (including drug-resistant strains) and a favorable safety profile. However, direct comparative evidence to support its use in combination with β-lactams in this setting is lacking. Therefore, the primary objective of this trial is to evaluate whether omadacycline combined with a β-lactam is non-inferior to the standard β-lactam plus moxifloxacin regimen for the treatment of sCAP in adults.
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 (200 mg iv once daily for the first day, then 100 mg iv q24h) plus β-lactam therapy (piperacillin-tazobactam 4.5 g iv q8h or meropenem 1 g iv q8h).…
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.
Read the paper
Related studies
- Structural and topological analysis of thiosemicarbazone-based metal complexes: computational and experimental study of bacterial biofilm inhibition and antioxidant activity
- Toward better cures for Mycobacterium abscessus lung disease
- Challenges for global antibiotic regimen planning and establishing antimicrobial resistance targets: implications for the WHO Essential Medicines List and AWaRe antibiotic book dosing
- Design, Synthesis and In vitro Antitubercular Effect of New Chalcone Derivatives Coupled with 1,2,3‐Triazoles: A Computational Docking Techniques
- Upregulation of pmrA, pmrB, pmrC, phoQ, phoP, and arnT genes contributing to resistance to colistin in superbug Klebsiella pneumoniae isolates from human clinical samples in Tehran, Iran
- Whole-genome sequencing of clinical isolates of Citrobacter Europaeus in China carrying blaOXA−48 and blaNDM−1
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.