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

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ClinicalTrials.gov Identifier: NCT03526718
Recruitment Status : Completed
First Posted : May 16, 2018
Last Update Posted : May 11, 2021
Sponsor:
Collaborators:
Damien Foundation
Programme National de lutte contre la Lèpre et la Tuberculose, Comores
Instituto Oswaldo Cruz
R2STOP
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

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.


Condition or disease
Leprosy

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Study Type : Observational [Patient Registry]
Actual Enrollment : 889 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Years
Official Title: Improved Understanding of Ongoing Transmission of Leprosy in the Comoros, a Region Hyperendemic for the Disease.
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Leprosy




Primary Outcome Measures :
  1. Leprosy incidence among contacts of an index patient [ Time Frame: The incidence rate ratio will be recorded during the 3-year recruitment period op the study. ]
    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.


Secondary Outcome Measures :
  1. Recent transmission cluster [ Time Frame: 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. ]
    Transmission links will be defined as identical genotypes based on their "variable number of tandem repeat(VNTR)"- profile. The definition of clustering will be based on comparison of the copy number of the VNTRs using two different stringencies: either considering those that presented identical copy number for all 17 alleles, or considering those that had identical copy number excluding the most variable loci.

  2. Patient and health system delay. [ Time Frame: 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. ]
    Mean patient and health systems delay with 95% confidence interval will be calculated. The questionnaire will comprise questions on the duration of the symptoms and the health seeking behavior of the patient.


Biospecimen Retention:   Samples With DNA
Skin biopsy (non facial), Nasal swabs, Fingerstick blood and Slit skin smears (non facial and only for multibacillary patients)


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526718


Locations
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Comoros
Damien Foundation
Moutsamoudou, Anjouan, Comoros
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
Damien Foundation
Programme National de lutte contre la Lèpre et la Tuberculose, Comores
Instituto Oswaldo Cruz
R2STOP
Investigators
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Principal Investigator: Bouke C de Jong, MD,PhD Institute of Tropical Medicine
Additional Information:

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Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT03526718    
Other Study ID Numbers: 1147/16
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data sharing will be considered once the datasets are locked at time of publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Tropical Medicine, Belgium:
Transmission
Genotyping
Risk factors
Additional relevant MeSH terms:
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Leprosy
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections