Ciprofloxacin versus Aminoglycoside-Ciprofloxacin for Bubonic Plague
Abstract
Background: Plague is a high-consequence infectious disease with epidemic potential. Current treatment guidelines are based on weak evidence.
Methods: We enrolled persons (excluding pregnant persons) in Madagascar who had clinically suspected bubonic plague during 2020-2024. Using an open-label noninferiority design, we compared two treatments included in the national plague guidelines: oral ciprofloxacin for 10 days (ciprofloxacin monotherapy) or injectable aminoglycoside for 3 days followed by oral ciprofloxacin for 7 days (aminoglycoside-ciprofloxacin). The primary end point was treatment failure on day 11, with treatment failure defined as death, fever, secondary pneumonic plague, or alternative or prolonged plague treatment. To show noninferiority of ciprofloxacin monotherapy among patients with laboratory-confirmed or probable infections, the upper boundary of the 95% confidence interval around the risk difference had to be less than 15 percentage points.
Results: A total of 933 patients underwent screening; 450 patients with suspected bubonic plague were enrolled and underwent randomization. A total of 220 patients (110 per group) had confirmed infection, and 2 (1 per group) had probable infection. Of the patients who underwent randomization, 53.2% were male, and the median age was 14 years (range, 2 to 72). Ciprofloxacin monotherapy was noninferior to aminoglycoside-ciprofloxacin therapy: among the patients with confirmed or probable infection, treatment failure…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 933 participants or records.
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