Bubonic plague
IMASOY – Bubonic Plague
IMASOY is an open-label, randomised, non-inferiority trial of the efficacy and safety of ciprofloxacin versus aminoglycoside + ciprofloxacin in the treatment of bubonic plague.
The trial has been conducted at 82 peripheral health centres (Centres de Santé de Base) in Madagascar by Institut Pasteur de Madagascar, Centre Hospitalier Universitaire Joseph Raseta Befelatanana, Centre Infectiologie Charles Merieux, the University of Oxford (Sponsor) and the London School of Hygeine and Tropical Medicine.
Current status
On 31 March 2024, the IMASOY trial concluded recruitment, surpassing its minimum target sample size with over 220 confirmed and probable cases enrolled. The results are expected to be published towards the end of 2024.
For further information about IMASOY please contact josephine.bourner@ndm.ox.ac.uk
Background
Current treatment regimens for bubonic plague rely heavily on aminoglycosides, which are costly, cause high toxicity, require injections and are in low global supply.
Ciprofloxacin has been shown to have high therapeutic efficacy in the treatment of plague, equivalent or superior to current treatment regimens. It also can be administered orally, having good oral bioavailability, an established safety record, and is cheaper and more readily available in LMICs (where over 98% of the global disease burden lies).
Intervention
Patients enrolled in participating peripheral health centres were randomised to receive either:
- Aminoglycoside followed by ciprofloxacin (the current first-line treatment in Madagascar)
- Ciprofloxacin alone (the current third-line treatment in Madagascar)
Patients are then followed from 21 days to 1 year after their enrolment depending on their serological status.
Endpoint
The primary endpoint of the trial will assess the proportion of patients with bubonic plague who have a therapeutic response to treatment.
Once a suspected case of plague has been identified, assessed for eligibility and included in the trial, they will be randomised to one of two possible treatments: aminoglycoside + ciprofloxacin OR ciprofloxacin alone. Treatment in both arms will last for 10 consecutive days. Included patients will then be followed up on days 11 and 21. For those who receive a positive result for plague at day 21, they will attend another follow-up visit at month 3 and for those still testing positive for plague at month 3, they will attend a final visit at month 12
Publication library
The IMASOY trial team preparing to visit a patient in Tsiroanomandidy. Josephine Bourner, ISARIC
One of the health centres participating in the trial in Ambositra. Josephine Bourner, ISARIC