Leprosy Clinical Trial - Improved Understanding of Ongoing Transmission of

Status Completed

Clinical Trial Summary

Despite decades of a solid leprosy control program, including active case finding and follow-up on therapeutic outcome, the Comoros islands of Anjouan and Moheli continue to be hyperendemic for leprosy, with leprosy case notifications far exceeding those for tuberculosis, while the third island, Grande Comore, presents few cases. The high proportion (31% in 2015) of disease in children indicates that recent transmission is a major driver of the persistent endemicity, and that present control measures are not sufficient. The low proportion (2.6% average in last 10 years) of grade II disabilities in newly diagnosed cases indicates that case detection is early. The main objective of the present proposal is to identify which persons would most benefit from prophylactic treatment. The secondary objective is to unravel human, bacterial and environmental risk factors for transmission of and progression to leprosy disease, with the ultimate goal to reduce the leprosy incidence.. The program has remaining expertise to re-establish laboratory confirmation of leprosy patients, allowing to optimize and validate molecular genotyping techniques to complement conventional epidemiological investigations in a 3-year prospective cohort of leprosy patients and their close contacts, aiming to identify transmission links. A third objective is to document diagnostic delays in more detail As the leprosy control programme has initiated a pilot study on rifampicin prophylaxis in four villages on Anjouan in 2015, a prospective cohort study will permit measuring the leprosy incidence in close contacts as well as those in neighboring houses, who did or did not receive rifampicin prophylaxis. The expected outcome of this project will be to identify risk factors for leprosy transmission. Specifically, we expect to identify those contacts at highest risk of developing leprosy disease, who would most benefit from rifampicin prophylaxis or other preventive measures.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Leprosy

Clinical Trial Details

NCT number	NCT03526718
Study type	Observational [Patient Registry]
Source	Institute of Tropical Medicine, Belgium
Contact
Status	Completed
Phase
Start date	April 1, 2017
Completion date	December 31, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Improved Understanding of Ongoing Transmission of Leprosy in the Hyperendemic Comoros (ComLep) — ComLep

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms