Ciprofloxacin Versus Streptomycin and Ciprofloxacin for Bubonic Plague

• Status: Recruiting
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborators: Hôpital Universitaire Joseph Raseta Befelatanana CHU d'Antananarivo; Institut Pasteur de Madagascar
• Treatments: Ciprofloxacin; Streptomycin

Criteria

Inclusion Criteria:

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)

Pneumonic plague

• Patients of any age AND

• Recent onset (< 7 days) of fever (uncorrected axillary temperature ≥ 37.5C) or history of fever AND

• Cough AND

• Tachypnoea (respiratory rate > 24 in adults and age specific in children) AND

• Epidemiological link to a confirmed or probable case of primary or secondary pneumonic plague within 7 days of symptom onset

Exclusion Criteria:

• 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