Status:
COMPLETED
Ciprofloxacin Versus an Aminoglycoside Followed by Ciprofloxacin for Bubonic Plague
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Hôpital Universitaire Joseph Raseta Befelatanana CHU d'Antananarivo
Institut Pasteur de Madagascar
Conditions:
Plague, Bubonic
Plague, Pneumonic
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 an aminoglycoside (given on da...
Detailed Description
An individually randomised, open label, non-inferiority trial of ciprofloxacin versus an aminoglycoside and ciprofloxacin in patients with bubonic plague. We are using a non-inferiority design since t...
Eligibility Criteria
Inclusion
- Inclusion Criteria for randomisation to the bubonic plague treatment trial:
- 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)
- Exclusion Criteria to the bubonic plague treatment trial:
- Known allergy to aminoglycosides or fluoroquinolones
- Tendinitis
- Myasthenia gravis
- Theophylline or warfarin use
- Already treated for bubonic or pneumonic plague in the preceeding 3 months
- Women who report being pregnant
- Inclusion of patients to the pneumonic plague observational cohort:
- • Suspected, probable and confirmed cases of pneumonic plague
Exclusion
Key Trial Info
Start Date :
February 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2025
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT04110340
Start Date
February 15 2020
End Date
February 5 2025
Last Update
March 6 2025
Active Locations (1)
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1
Professor Mamy Randria
Antananarivo, Madagascar