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

NCT03526718 | Completed

• 1 other identifier: 1147/16
• Study Type: observational
• Target: 889
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Transmission; Genotyping; Risk factors

Outcome Measures

Primary Outcomes (1)

• Leprosy incidence among contacts of an index patient

  Incidence rate ratios among the contacts by proximity to the index patients will be calculated. Classification of contacts in proximity groups is a dynamic process. Persons belonging to the same household, surrounding households, entire village, or entire island may shift to closer proximity groups when leprosy patients are diagnosed in their environment. Since date of diagnosis, and any recent migration, will be recorded for each patient, we will be able to reallocate contacts to other circles and attribute to each contact a period of exposure within each circle.

  The incidence rate ratio will be recorded during the 3-year recruitment period op the study.

Secondary Outcomes (2)

• Recent transmission cluster

  All the samples over the three years should be analysed the able to fully explore the transmission links. Therefore, this outcome will be assessed through study completion, which will probably take1 year.

• Patient and health system delay.

  This outcome can be calculated at the end of the recruitment phase of the study.Therefore, this outcome will be assessed through study completion, which will probably take1 year.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The Comoros islands, located between Madagascar and Mozambique, continue to be hyperendemic for leprosy. Periodic active case finding across the entire island of Anjouan is in place, resulting in early case detection, and every patient identified is being treated with highly effective multi drug therapy. Nevertheless, the high proportion of leprosy in children (31% were \<15y old in 2015) in combination with a low relapse rate (\<2%) indicate transmission continues unabated. The majority of the patients in Anjouan are paucibacillary.

You may qualify if:

• in the prospective cohort study: All newly diagnosed leprosy patients (any age) on the island of Anjouan who provide written informed consent.
• In the in-depth interviews: Patients who are part of a cluster and provide written informed consent. Additional written informed consent will be asked for questions in which the identity of other member(s) of a cluster needs to be revealed.

You may not qualify if:

• in the prospective cohort study: None.
• In the in-depth interviews: Patients belonging to clusters not extending beyond the same first or second circle

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Damien Foundation: collaborator
• Programme National de lutte contre la Lèpre et la Tuberculose, Comores: collaborator
• Instituto Oswaldo Cruz: collaborator
• R2STOP: collaborator

Study Sites (1)

Damien Foundation

Moutsamoudou, Ndzuwani, Comoros

Location

Related Publications (1)

• Marijke Braet S, Jouet A, Aubry A, Van Dyck-Lippens M, Lenoir E, Assoumani Y, Baco A, Mzembaba A, Cambau E, Vasconcellos SEG, Rigouts L, Suffys PN, Hasker E, Supply P, de Jong BC. Investigating drug resistance of Mycobacterium leprae in the Comoros: an observational deep-sequencing study. Lancet Microbe. 2022 Sep;3(9):e693-e700. doi: 10.1016/S2666-5247(22)00117-3. Epub 2022 Jul 15.

  PMID: 35850123 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Skin biopsy (non facial), Nasal swabs, Fingerstick blood and Slit skin smears (non facial and only for multibacillary patients)

MeSH Terms

Conditions

Leprosy

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Bouke C de Jong, MD,PhD

  Institute of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 16, 2018
• Study Start: April 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

CO (1)