Ciprofloxacin Versus an Aminoglycoside Followed by Ciprofloxacin for Bubonic Plague (IMASOY)
Plague, Bubonic, Plague, Pneumonic
About this trial
This is an interventional treatment trial for Plague, Bubonic
Eligibility Criteria
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
Sites / Locations
- Professor Mamy RandriaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Other
Ciprofloxacin Arm
Control arm
Adults: Ciprofloxacin 500mg orally twice daily (or 400mg IV twice daily for those who cannot take oral medication) for 10 days; Children:Ciprofloxacin 15mg/kg twice daily (max 500mg per dose) orally (or 10mg/kg IV twice daily for those who cannot take oral - maximum dose 400mg) for 10 days.
Adults: streptomycin 1g twice daily for three days, followed by ciprofloxacin 500mg orally twice daily (or ciprofloxacin 400mg twice daily by IV for those who cannot take it orally) for an additional 7 days. OR 2.5mg/kg IV gentamicin twice daily for 3 days followed by ciprofloxacin 500 mg orally twice daily (or ciprofloxacin 400 mg twice daily IV for those who cannot take oral) for a further 7 days. Children: streptomycin 15mg/kg twice daily for three days followed by ciprofloxacin 15mg/kg twice daily (max 500mg per dose) orally (or 10mg/kg IV twice daily for those who cannot take oral - maximum dose 400mg) for 7 additional days. OR 2.5mg/kg IV gentamicin twice daily for 3 days, followed by ciprofloxacin 15mg/kg (max 500mg per dose) orally (or 10mg/kg IV twice daily for those who cannot take the oral route) for a further 7 days.