A prospective (sero-)epidemiological study on contact transmission and chemoprophylaxis in leprosy
| ISRCTN | ISRCTN61223447 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61223447 |
| Protocol serial number | N/A |
| Sponsor | Erasmus Medical Centre (The Netherlands) |
| Funders | The Leprosy Mission International (UK), American Leprosy Missions (USA) |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 18/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr F.J. Moet
Scientific
Scientific
Erasmus Medical Centre Rotterdam
Department of Public Health
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
| f.moet@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | COLEP |
| Study objectives | Rifampicin is an effective chemoprophylactic intervention method to prevent leprosy among close contacts of leprosy patients. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Rifampicin |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 20000 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/05/2002 |
| Date of final enrolment | 31/10/2007 |
Locations
Countries of recruitment
- Bangladesh
- Netherlands
Study participating centre
Erasmus Medical Centre Rotterdam
Rotterdam
3000 DR
Netherlands
3000 DR
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 05/04/2008 | Yes | No |
