At a glance
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A Randomized, Non-inferiority, Active Controlled Clinical Trial to Evaluate the Safety and Efficacy of Ciprofloxacin Versus Doxycycline in the Treatment of Plague in Humans
In Brief
A Phase 2 clinical trial evaluating ciprofloxacin and doxyxcycline for Plague. Completed, enrolled 5 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
* For adults and children aged \> 15 years: 500 mg orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer; * For children aged 8-15 years: 15 mg/kg (maximum 500 mg per dose) orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer.
* For adults and children weighing 45 kg or more: 200 mg orally one time as an initial loading dose, followed by 100 mg orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer; * For children weighing less than 45 kg: 4.4 mg/kg orally one time as an initial loading dose, followed by 2.2 mg/kg orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer.