A prospective (sero-)epidemiological study on contact transmission and chemoprophylaxis in leprosy.
Completed
- Conditions
- eprosy is an infectious disease caused by Mycobacterium leprae, which is spread from person to person mainly through nasal discharges. Contacts of leprosy patients are known to have an increased risk of contracting leprosy.
- Registration Number
- NL-OMON27022
- Lead Sponsor
- Department of Public Health of the University Medical Center (Erasmus MC) Rotterdam, The NetherlandsKIT (Royal Tropical Institute) Biomedical Research, Amsterdam, The NetherlandsDanish Bangladesh Leprosy Mission (DBLM), Nilphamari, Bangladesh
- Brief Summary
Moet FJ, Oskam L, Faber R, Pahan D and Richardus JH. A study on transmission and a trial of chemoprophylaxis in contacts of leprosy patients: design, methodology and recruitment findings of COLEP. Lepr Rev 2004;75:376-88.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20000
Inclusion Criteria
Patients should give consent for approaching their contacts for the trial
Inclusion criteria for contacts:
Exclusion Criteria
Exclusion criteria for contacts:
1. Any contact who refuses to be included;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is the number of new leprosy patients emerging from the contact groups. The proportions between the rifampicin and the placebo group will be compared at 2-years intervals.
- Secondary Outcome Measures
Name Time Method Analysis will be carried out in order to define special groups at risk. The results of the serological tests will also be compiled and analysed. The number of leprosy patients found in the referent group will be used to calculate the prevalence rate (at intake) and the incidence rate (during follow-up) in the general population, allowing for calculation of relative risks among the contacts.