Ciprofloxacin Versus an Aminoglycoside Followed by Ciprofloxacin for Bubonic Plague (NCT04110340) | Clinical Trial Compass
CompletedPhase 3
Ciprofloxacin Versus an Aminoglycoside Followed by Ciprofloxacin for Bubonic Plague
Madagascar222 participantsStarted 2020-02-15
Plain-language 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 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with bubonic plague with a therapeutic response (assessed on day 11).Therapeutic response is defined as follows for subjects with a visible bubo: