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

NCT03526718 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 889

Last updated 2021-05-11

No results posted yet for this study

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.

Conditions

  • Leprosy

Sponsors & Collaborators

  • Damien Foundation

    collaborator OTHER

  • Programme National de lutte contre la Lèpre et la Tuberculose, Comores

    collaborator UNKNOWN

  • Instituto Oswaldo Cruz

    collaborator UNKNOWN

  • R2STOP

    collaborator UNKNOWN

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Bouke C de Jong, MD,PhD · Institute of Tropical Medicine

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Comoros

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03526718 on ClinicalTrials.gov