Condition category
Infections and Infestations
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
18/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr F.J. Moet

ORCID ID

Contact details

Erasmus Medical Centre Rotterdam
Department of Public Health
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
f.moet@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

COLEP

Study hypothesis

Rifampicin is an effective chemoprophylactic intervention method to prevent leprosy among close contacts of leprosy patients.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Leprosy

Intervention

All 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. According to bodyweight and age, two to four 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.

Dosage of rifampicin according to age and body weight:
Adult greater than 35 kg: 600 mg
Adult less than 35 kg: 450 mg
Child 10 - 14 years: 450 mg
Child 5 - 9 years: 300 mg

Intervention type

Drug

Phase

Not Specified

Drug names

Rifampicin

Primary outcome measures

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 two-years intervals.

Secondary outcome measures

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.

Overall trial start date

01/05/2002

Overall trial end date

31/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients 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 (five 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20,000

Participant exclusion criteria

Exclusion criteria for contacts:
1. Any contact who refuses to be included
2. Any contact being pregnant
3. Any contact currently on tuberculosis (TB) or leprosy treatment (however, released from treatment [RFT] 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

Recruitment start date

01/05/2002

Recruitment end date

31/10/2007

Locations

Countries of recruitment

Bangladesh

Trial participating centre

Erasmus Medical Centre Rotterdam
Rotterdam
3000 DR
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Department of Public Health
P.O. Box 1738
Rotterdam
3000 DR
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/content/englishindex.htm

Funders

Funder type

Charity

Funder name

The Leprosy Mission International (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

American Leprosy Missions (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18332051

Publication citations

  1. Results

    Moet FJ, Pahan D, Oskam L, Richardus JH, , Effectiveness of single dose rifampicin in preventing leprosy in close contacts of patients with newly diagnosed leprosy: cluster randomised controlled trial., BMJ, 2008, 336, 7647, 761-764, doi: 10.1136/bmj.39500.885752.BE.

Additional files

Editorial Notes