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A randomised controlled trial to evaluate the efficacy and safety of treatments for bubonic plague has enrolled over 220 patients in Madagascar, marking a critical milestone in evidence generation for plague treatments.

The plague clinical trial field team in Madagascar. Credits: Institut Pasteur de Madagascar
The plague clinical trial field team in Madagascar. Credits: Institut Pasteur de Madagascar

Plague has afflicted humanity for millennia, and is still a high-risk pathogen today. It is presently endemic in the Democratic Republic of the Congo, Madagascar and Peru, while sporadic cases have also been reported in the USA and China in the last five years. 

Plague can be deadly without timely intervention, with a case fatality ratio of approximately 15% to 17%.

However, current treatments are based on weak evidence, as until now no conclusive clinical trial has been conducted to generate robust clinical evidence for an accessible and effective treatment regimen for the disease. 

The IMASOY trial in Madagascar has this month successfully concluded enrolment with over 220 cases of confirmed or probable bubonic plague.

IMASOY is the first clinical trial of this scale to evaluate the efficacy and safety of treatments for bubonic plague. With results expected in the last quarter of 2024, this enrolment milestone is a significant step forward in the challenging journey to strengthen the evidence-base available to clinicians, policymakers and patients. 

The trial is conducted as a collaboration between the University of Oxford, the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), which is hosted by the Pandemic Sciences Institute, Institut Pasteur Madagascar (IPM), CHU Joseph Befelatanana, Centre d’Infectiologie Charles Mérieux (CICM), and the London School of Hygiene & Tropical Medicine (LSHTM)

The randomised controlled clinical trial first started enrolment in 2020 to assess a 10-day oral ciprofloxacin treatment compared to the first-line treatment in Madagascar, consisting of three days of an injectable aminoglycoside followed by seven days of oral ciprofloxacin. 

Professor Piero Olliaro, ISARIC Director of Science and Professor of Poverty Related Infectious Diseases at the Pandemic Sciences Institute said: 'Clinical trials of plague have traditionally been challenging due to the operational complexities of conducting a trial in plague-endemic regions and the lack of established trial methodologies. Achieving the planned sample size of this trial is a monumental achievement made possible by the collaboration between the institutions involved and the healthcare personnel of 82 peripheral health centres and hospitals in 13 districts in Madagascar.'

Detailed findings are expected at the end of 2024. This project is funded by Wellcome and UK International Development from the UK government.

Read more about the IMASOY trial.