Leprosy 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.
Conditions
Interventions
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 consis
Adult <35 kg: 450 mg
Child 10-14 years: 450 mg
Child 5-9 years
300 mg.
Sponsors
Department of Public Health of the University Medical Center (Erasmus MC) Rotterdam, The Netherlands
KIT (Royal Tropical Institute) Biomedical Research, Amsterdam, The Netherlands
Danish Bangladesh Leprosy Mission (DBLM), Nilphamari, Bangladesh
Eligibility
Inclusion criteria
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 (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 criteria
Exclusion criteria: Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactF.J. Moet
Erasmus Medical Center Rotterdam, Department of Public Health, P.O. Box 1738
Outcome results
None listed