An Open-label, Randomised, Non-inferiority Trial of the Efficacy and Safety of Ciprofloxacin Versus an Aminoglycoside Followed by Ciprofloxacin in the Treatment of Bubonic Plague
The primary objective of this trial is to test the hypothesis that ciprofloxacin monotherapy given (orally, intravenously, or combination) for 10 days is non-inferior to an aminoglycoside (given on days 1-3) followed by ciprofloxacin (given on days 4-10) in the treatment of bubonic plague. Secondary objectives are: \- to evaluate the level and kinetics of anti-Y. pestis antibodies of patients (bubonic and pneumonic plague) included in the study (anti-F1 ELISA techniques) at D1, D11, D21, M3 for patients who are positive at D21, and M12 for patients who are positive at M3. The tertiary objectives are: \- to evaluate the level and kinetics of the levels of anti-Y. pestis antibodies and circulating F1 antigen of the patients (bubonic and pneumonic plague) included in the study (Luminex MagPix techniques with a Multiplex containing anti-F1 and rLcrV antigens and an F1 antigen capture multiplex) at D1, D11, D21, M3 for patients positive at D21, and M12 for patients who are positive at M3. Observational non-comparative study of pneumonic plague * The primary objective is to document the efficacy and safety of the currently recommended combination therapy treatment of pneumonic plague - an aminoglycoside (streptomycin or gentamicin) and ciprofloxacin combination therapy. * The secondary and tertiary objectives of the bubonic plague trial also apply to the pneumonic plague cohort.
⁃ Bubonic plague
• Patients of any age AND
• Recent onset (\< 10 days) of fever (uncorrected axillary temperature ≥ 37.5C) or history of fever AND
• One or more buboes (tender lymph node swelling) AND
• Residence or travel to a plague endemic area in Madagascar within 14 days of the onset of symptoms AND
• Patients identified as clinically suspected of plague by health personnel (doctors or paramedics)