Ciprofloxacin Versus Streptomycin and Ciprofloxacin for Bubonic Plague
Status:
Recruiting
Trial end date:
2021-03-31
Target enrollment:
Participant gender:
Summary
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 streptomycin
(given on days 1-3) followed by ciprofloxacin (given on days 4-10) in the treatment of
bubonic plague.
Secondary objectives are:
-to collect data on the effectiveness of ciprofloxacin in the treatment of pneumonic plague,
although the trial is not able to formally assess the non-inferiority of ciprofloxacin
monotherapy compared to streptomycin and ciprofloxacin combination therapy in pneumonic
plague.
--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 and M3 for
patients who are positive at D21.
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 and M3 for patients positive at
D21.
- to evaluate the extent to which qPCR is positive in the blood of confirmed patients on
D1.
- to evaluate the performance of new rapid tests that may be made available to the Plague
Unit of the Institut Pasteur de Madagascar.
Phase:
Phase 3
Details
Lead Sponsor:
University of Oxford
Collaborators:
Hôpital Universitaire Joseph Raseta Befelatanana CHU d'Antananarivo Institut Pasteur de Madagascar