Reporting of antibiotic resistance in randomized controlled trials of new antibiotics: a systematic review.
Itay Zahavi, Amir Tafesh, Nimrod Puri et al.
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In 30 seconds
This systematic review evaluated the planning and reporting of antibiotic susceptibility testing (AST) in randomized controlled trials (RCTs) of new antibiotics. It included 57 RCTs involving adults and children with bacterial infections. The study found that only 29.8% of trials reported real-time baseline AST, highlighting inconsistencies in resistance assessment in recent antibiotic trials.
Key findings
- Real-time baseline AST was reported in 17 of 57 (29.8%) trials.
- Central-laboratory baseline AST was reported in 48 of 57 (84.2%) trials.
- Resistance acquisition was reported in 22 of 57 (38.6%) trials.
- Only 2 of 57 trials planned to assess all four resistance domains.
Why it matters
Understanding the planning and reporting of antibiotic resistance in clinical trials is crucial for interpreting the efficacy and safety of new antibiotics. Inconsistent reporting may hinder the assessment of resistance trends and impact clinical decision-making.