Bubonic plague

Currently recommended treatments for plague have been approved on experimental bases but no clinical evidence of efficacy in humans.

Despite the overall downward trend in plague incidence, the disease still causes significant morbidity and mortality primarily in Madagascar and the Democratic Republic of the Congo; furthermore, the widespread reservoir makes several countries vulnerable to human infections. It is therefore critical to strengthen the evidence-base for treatment regimens through well-conducted, conclusive clinical trials.

We are conducting a range of activities to help fill knowledge gaps about bubonic plague clinical research and case-management:

Clinical trial

In March 2024, we completed enrolment into a randomised controlled trial comparing two treatment regimens for plague. IMASOY (NCT04110340), which has taken place in rural health centres across Madagascar by local partner institutions, is the first randomised controlled trial powered to evaluate the efficacy and safety of treatments for bubonic plague.

Read more about IMASOY


Observational study

In March 2024, we have completed enrolment to an observational cohort study that aims to characterise the clinical and sonographic evolution of a plague bubo and compare the accuracy of different measurement tools. The study has taking place in rural health centres in Madagascar in partnership with Institut Pasteur de Madagascar and Worldwide Radiology who have provided ultrasound training to local clinicians. This study will be the first to describe systematically the bubo both clinically and using ultrasound imaging in multiple patients. 

Read more about the Bubo characterisation project

Clinical trial methodologies:

The change in size of a plague bubo has been used as a proxy for clinical recovery, but buboes are rarely systematically measured and the measurement methods that are currently used in clinical practice and research settings vary widely. Anecdotally, approximate size comparisons are often used in Madagascar, whereas in a small number of research studies a digital calliper has been used to measure the bubo and in rare cases ultrasound or CT scan has been used in clinical settings in the US. Accurate tools that are affordable and easy-to-use must be prioritised considering the burden of disease lies predominantly in clinical settings with limited resources. To understand whether a digital calliper is an appropriate measurement tool, we conducted a study comparing the accuracy, inter- and intra-rater agreement of measurements of artificial plague buboes.

Read more about the Bubo measurement project

Clinical characterisation:

A substantial barrier limiting the advancement of clinical trials evaluating plague therapeutics has been the lack of robust methodologies, which rely on an accurate and complete understanding of disease presentation, evolution and patient outcomes. While plague has been described in a number of case studies, observational studies and few inconclusive small trials, there has been no systematic synthesis of the clinical characterisation of the disease. We therefore conducted a systematic review to summarise the existing information that has been published about the signs and symptoms of plague at first presentation, how these symptoms evolve and the types of outcomes patients experience.

Read more about the clinical characterisation of bubonic plague

Researchers successfully enrol over 220 cases for landmark plague trial

The first randomised controlled trial powered to evaluate the efficacy and safety of treatments for bubonic plague has enrolled over 220 cases of confirmed or probable bubonic plague in Madagascar, marking a critical milestone in plague treatment research.  Plague has afflicted humanity for millennia, and is still a high-risk pathogen today. However, current treatments are based on weak evidence, as no conclusive clinical trial has ever been conducted. Until today. The IMASOY trial in ...

Draft framework for clinical trials seeks public feedback

18 December 2023: The International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) is working with partners to create a framework on endpoint selection for clinical trials for outbreak-prone infectious diseases. This call for a public consultation invites feedback on what the framework does well, what could be improved and the limits of its potential application.


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