TY - JOUR KW - Rifampin KW - Prospective Studies KW - leprosy KW - Leprostatic Agents KW - Humans KW - Double-Blind Method AU - Moet J AU - Pahan D AU - Oskam L AU - Richardus JH AU - COLEP Study Group AB -

OBJECTIVE: To determine the effectiveness of chemoprophylaxis using a single dose of rifampicin to prevent leprosy in close contacts.

DESIGN: Single centre, double blind, cluster randomised, placebo controlled trial.

SETTING: Leprosy control programme in two districts of northwest Bangladesh with a population of more than four million.

PARTICIPANTS: 28,092 close contacts of 1037 patients with newly diagnosed leprosy. 21,711 contacts fulfilled the study requirements.

INTERVENTIONS: A single dose of rifampicin or placebo given to close contacts in the second month of starting the index patient's treatment, with follow-up for four years.

MAIN OUTCOME MEASURE: Development of clinical leprosy.

RESULTS: 18,869 of the 21,711 contacts (86.9%) were followed-up at four years. Ninety one of 9452 contacts in the placebo group and 59 of 9417 in the rifampicin group had developed leprosy. The overall reduction in incidence of leprosy using a single dose of rifampicin in the first two years was 57% (95% confidence interval 33% to 72%). The groups did not differ between two and four years. The overall number needed to treat (NNT) to prevent a single case of leprosy among contacts was 297 (95% confidence interval 176 to 537). Differences were found between subgroups at two years, both in reduction of incidence and in NNT.

CONCLUSION: A single dose of rifampicin given to contacts of patients with newly diagnosed leprosy is effective at preventing the development of clinical leprosy at two years. The effect was maintained, but no difference was seen between the placebo and rifampicin groups beyond two years.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN61223447 [controlled-trials.com].

BT - British medical journal C1 -

http://www.ncbi.nlm.nih.gov/pubmed/18332051?dopt=Abstract

CN - MOET2008b DO - 10.1136/bmj.39500.885752.BE IS - 7647 J2 - BMJ LA - eng N2 -

OBJECTIVE: To determine the effectiveness of chemoprophylaxis using a single dose of rifampicin to prevent leprosy in close contacts.

DESIGN: Single centre, double blind, cluster randomised, placebo controlled trial.

SETTING: Leprosy control programme in two districts of northwest Bangladesh with a population of more than four million.

PARTICIPANTS: 28,092 close contacts of 1037 patients with newly diagnosed leprosy. 21,711 contacts fulfilled the study requirements.

INTERVENTIONS: A single dose of rifampicin or placebo given to close contacts in the second month of starting the index patient's treatment, with follow-up for four years.

MAIN OUTCOME MEASURE: Development of clinical leprosy.

RESULTS: 18,869 of the 21,711 contacts (86.9%) were followed-up at four years. Ninety one of 9452 contacts in the placebo group and 59 of 9417 in the rifampicin group had developed leprosy. The overall reduction in incidence of leprosy using a single dose of rifampicin in the first two years was 57% (95% confidence interval 33% to 72%). The groups did not differ between two and four years. The overall number needed to treat (NNT) to prevent a single case of leprosy among contacts was 297 (95% confidence interval 176 to 537). Differences were found between subgroups at two years, both in reduction of incidence and in NNT.

CONCLUSION: A single dose of rifampicin given to contacts of patients with newly diagnosed leprosy is effective at preventing the development of clinical leprosy at two years. The effect was maintained, but no difference was seen between the placebo and rifampicin groups beyond two years.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN61223447 [controlled-trials.com].

PY - 2008 SP - 761 EP - 4 T2 - British medical journal TI - Effectiveness of single dose rifampicin in preventing leprosy in close contacts of patients with newly diagnosed leprosy: cluster randomised controlled trial. UR - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2287265/pdf/bmj-336-7647-res-00761-el.pdf VL - 336 SN - 1756-1833 ER -