This study is a randomized, open-label, non-inferiority clinical trial evaluating the safety and efficacy of oral ciprofloxacin compared to oral doxycycline for the treatment of plague in humans. Participants aged 8 years and older with suspected plague presenting to health facilities in Uganda will be enrolled and randomized to receive either ciprofloxacin or doxycycline. Plague is a severe, potentially fatal infectious disease caused by Yersinia pestis, with high case fatality rates if not promptly treated. Current treatment options include aminoglycosides and tetracyclines such as doxycycline; however, limitations include availability, route of administration, and safety concerns in certain populations. Ciprofloxacin is a widely available fluoroquinolone with favorable pharmacokinetics and demonstrated activity against Y. pestis in vitro and in animal models, but clinical data in humans are limited. The primary outcome is all-cause mortality within 14 days of enrollment among participants with laboratory-confirmed plague. Secondary outcomes include time to defervescence and antimicrobial-associated adverse events. This study aims to determine whether ciprofloxacin is non-inferior to doxycycline and to inform treatment guidelines for plague, particularly in resource-limited settings.
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all cause mortality
Timeframe: 14 days