Associated organisationsCentre d'Infectiologie Charles Mérieux · Centre Hospitalier Universitaire Tambohobe · Institut Pasteur de Madagascar · London School of Hygiene & Tropical Medicine · University Hospital Joseph Raseta Befelatanana · University of OxfordEurope PMC affiliations are not treated as award recipients or mapped locations.
Funding£1.7M
PeriodApr 2019 — Sept 2022
In plain English
AI plain-English summary
A 10-day course of the common antibiotic ciprofloxacin alone may be just as effective as the current standard treatment for plague, which combines two different drugs. This matters because the current first-line treatment for plague—streptomycin injections followed by oral ciprofloxacin—is difficult to deliver in remote areas, requires cold storage, and can cause side effects. A simpler, all-oral regimen would be far easier to stockpile and administer during outbreaks, especially in resource-limited settings like Madagascar, which experienced a large pneumonic plague outbreak in 2017. The trial will randomise 190 patients with confirmed or probable bubonic plague to receive either ciprofloxacin alone for 10 days or the standard streptomycin-plus-ciprofloxacin schedule, with the primary outcome measured at day 10. If ciprofloxacin alone proves non-inferior, it could become the new standard of care, simplifying treatment protocols and reducing the logistical burden on health systems during future plague outbreaks. This is a pragmatic, directly applicable clinical trial with no fundamental science component—its success would change how plague is treated in the field.
View original technical description
Background: In 2017 Madagascar experienced a large outbreak of pneumonic plague, with cases being treated with the national recommended schedule of streptomycin. Two seperate post-outbreak technical workshops in 2018 (Pasteur Institute, 9-10 July; and joint Madagascar Ministry of Public Health and WHO meeting, July 17-20), which together convened around 100 plague experts, recommended a clinical trial of alternative treatments for plague. Aim: To test the hypothesis that ciprofloxacin monotherapy (orally, intravenously, or combination) for 10 days is non-inferior to streptomycin (given on days 1-3) followed by ciprofloxacin (given on days 4-10) in the treatment of bubonic plague. Methods: An open-label, individually randomised, non-inferiority trial of the efficacy and safety of ciprofloxacin versus active control for the treatment of bubonic plague in Madagascar. Primary outcome: Therapeutic response assessed at day 10 after randomisation Duration: Three years Sample size: 190 confirmed/probable bubonic plague patients (95 per group) will provide 90% power to demonstrate non-inferiority of treatment success of ciprofloxacin compared to streptomycin plus ciprofloxacin, within a non-inferiority margin of 15% and based on a 2.5% one-sided confidence interval. Calculations assume 10% loss to follow up of patients before the endpoint assessment on day 10.
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