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A prospective (sero-)epidemiological study on contact transmission and chemoprophylaxis in leprosy.


- candidate number1782
- NTR NumberNTR394
- ISRCTNISRCTN61223447
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR25-okt-2005
- Secondary IDsN/A 
- Public TitleA prospective (sero-)epidemiological study on contact transmission and chemoprophylaxis in leprosy.
- Scientific TitleA prospective (sero-)epidemiological study on contact transmission and chemoprophylaxis in leprosy.
- ACRONYMCOLEP
- hypothesisRifampicin is an effective chemoprophylactic intervention method to prevent leprosy among close contacts of leprosy patients.
- Healt Condition(s) or Problem(s) studiedLeprosy
- Inclusion criteriaPatients should give consent for approaching their contacts for the trial Inclusion criteria for contacts:
1. Those living in the same house;
2. Those living in a house sharing the same kitchen;
3. First neighbours;
4. Close business or social contacts, including other relatives. To be included into this category one has to be in contact with the patient on a daily base (5 or more days a week) and during several hours a day;
5. Second neighbours.
All divided into spouse, child, parent, sibling, other relative, relative-in-law, non-relative.
- Exclusion criteriaExclusion criteria for contacts:
1. Any contact who refuses to be included;
2. Any contact being pregnant;
3. Any contact currently on TB or leprosy treatment (however, RFT-ed patients should be included);
4. Any contact below 5 years of age;
5. Any contact suffering from jaundice;
6. Any contact living only temporarily in the area;
7. Any contact found to suffer from leprosy at the initial survey;
8. Any contact already enrolled in the study via the contact.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2002
- planned closingdate31-okt-2007
- Target number of participants20000
- InterventionsAll close contacts of 1000 consecutive new leprosy patients in the districts of Nilphamari and Rangpur (Bangladesh) who are recruited for the study are considered for inclusion. A contact group consists of around 20 individuals. A single dose of rifampicin or a placebo is given to all included contacts. The rifampicin comes in capsules of 150 mg and the dosage is the same as recommended in the guidelines of the national leprosy control programme of Bangladesh and DBLM (table). According to bodyweight and age, 2 to 4 capsules are taken by the contact under direct supervision of a DBLM staff member. All the contacts of one patient receive medication from the same container.Table: Dosage of rifampicin according to age and body weightAge/weight .
Dose of chemoprophylaxis.
Adult >35 kg: 600 mg;
Adult <35 kg: 450 mg;
Child 10-14 years: 450 mg;
Child 5-9 years; 300 mg.
- Primary outcomeThe 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 outcomeAnalysis 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. F.J. Moet
- CONTACT for SCIENTIFIC QUERIESMD. Dr. J.H. Richardus
- Sponsor/Initiator Erasmus Medical Center, Department of Public Health, Royal Tropical Institute (KIT), Bio-Medical Research, Danish Bangladesh Leprosy Mission (DBLM)
- Funding
(Source(s) of Monetary or Material Support)
American Leprosy Mission, The Leprosy Mission International
- PublicationsMoet 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.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD25-okt-2005 - 13-jan-2010


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