A prospective (sero-)epidemiological study on contact transmission and chemoprophylaxis in leprosy
- Conditions
- eprosyInfections and InfestationsLeprosy
- Registration Number
- ISRCTN61223447
- Lead Sponsor
- Erasmus Medical Centre (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20000
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.
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
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 two-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.