Dose Selection for Ceftibuten Combined with Avibactam Tomilopil, a Potential Oral Alternative to Carbapenems for Patients with Complicated Urinary Tract Infections.
Siddhee A Sahasrabudhe, Satoshi Shoji, Abhijeet S Jakate et al.
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In 30 seconds
This Phase I randomized controlled trial evaluated the safety, tolerability, and pharmacokinetics of avibactam tomilopil combined with ceftibuten in healthy participants. The study found that plasma avibactam exposure increased proportionately with dose, leading to the recommendation of a fixed-dose combination of ceftibuten 400 mg and avibactam tomilopil 1200 mg for further evaluation in patients with complicated urinary tract infections.
Key findings
- Plasma avibactam exposure increased proportionately with doses of 900 to 1350 mg.
- Ceftibuten 400 mg combined with avibactam tomilopil 1200 mg is proposed for Phase 3 evaluation.
- Both avibactam and cis-ceftibuten had similar plasma half-lives.
- Negligible food effect on ceftibuten exposures was observed.
Why it matters
The development of effective oral treatments for complicated urinary tract infections caused by resistant bacteria is crucial, especially given the lack of current options. This study provides a potential new therapeutic strategy.