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Effectiveness of single dose rifampicin in preventing leprosy in close contacts of patients with newly diagnosed leprosy: cluster randomised controlled trial

BMJ 2008; 336 doi: https://doi.org/10.1136/bmj.39500.885752.BE (Published 03 April 2008) Cite this as: BMJ 2008;336:761
  1. F Johannes Moet, research fellow1,
  2. David Pahan, medical doctor2,
  3. Linda Oskam, senior researcher3,
  4. Jan H Richardus, associate professor1
  5. for the COLEP Study Group
  1. 1Department of Public Health, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA Rotterdam, Netherlands
  2. 2Rural Health Program, Leprosy Mission Bangladesh, Nilphamari, Bangladesh
  3. 3Royal Tropical Institute, KIT Biomedical Research, Amsterdam, Netherlands
  1. Correspondence to: J H Richardus j.richardus{at}erasmusmc.nl
  • Accepted 13 February 2008

Abstract

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.

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

Participants28 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.

ConclusionA 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.

Footnotes

  • We thank the staff of the leprosy control unit and the statistical department of the Rural Health Programme (formerly Danish Bangladesh Leprosy Mission) in Nilphamari and Rangpur for their dedicated work, often under difficult conditions.

  • Contributors: FJM, LO, and JHR were responsible for planning, carrying out, and reporting the study. DP was responsible for planning and carrying out the study. JHR is guarantor. Scientific advice was provided by the following members of the COLEP Scientific Advisory Group: W Cairns S Smith, Wim H van Brakel, Paul R Klatser, Paul R Saunderson, and Steve G Withington. Ron P Schuring provided laboratory support. Roel Faber developed and maintained the database. Gerard J J M Borsboom provided statistical support.

  • Funding: American Leprosy Missions and the Leprosy Mission International.

  • Competing interests: None declared.

  • Ethical approval: This study was approved by the ethical review committee of the Bangladesh Medical Research Council in Dhaka (BMRC/ERC/2001-2004/799).

  • The COLEP Study Group consists of Wim H van Brakel, Paul R Klatser, Paul R Saunderson, W Cairns S Smith, Steve G Withington (scientific advisers), F Johannes Moet, Linda Oskam, David Pahan, Jan Hendrik Richardus (project director), Ron P Schuring, Roel Faber, and Gerard J J M Borsboom.

  • Provenance and peer review: Not commissioned; externally peer reviewed.

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