Renate Richardus1, Khorshed Alam2, Kallyan Kundu2, Johan Chandra Roy2, Tasnuva Zafar2, Abu Sufian Chowdhury2, Daan Nieboer3, Roel Faber3, C Ruth Butlin2, Annemieke Geluk4, Jan Hendrik Richardus5. 1. Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands; Department of Infectious Diseases, Leiden University Medical Centre, Leiden, The Netherlands. 2. Rural Health Program, The Leprosy Mission International Bangladesh, Nilphamari, Bangladesh. 3. Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. 4. Department of Infectious Diseases, Leiden University Medical Centre, Leiden, The Netherlands. 5. Department of Public Health, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. Electronic address: j.richardus@erasmusmc.nl.
Abstract
OBJECTIVE: To assess the effectiveness of single-dose rifampicin (SDR) after bacillus Calmette-Guérin (BCG) vaccination in preventing leprosy in contacts. METHODS: This was a single-centre, cluster-randomized controlled trial at a leprosy control programme in northwest Bangladesh. Participants were the 14988 contacts of 1552 new leprosy patients who were randomized into the SDR-arm (n=7379) and the SDR+arm (n=7609). In the intervention group, BCG vaccination was followed by SDR 8-12 weeks later. In the control group, BCG vaccination only was given. Follow-up was performed at 1year and 2 years after intake. The main outcome measure was the occurrence of leprosy. RESULTS: The incidence rate per 10000 person-years at risk was 44 in the SDR-arm and 31 in the SDR+arm at 1year; the incidence rate was 34 in the SDR-arm and 41 in the SDR+arm at 2 years. There was a statistically non-significant (p=0.148; 42%) reduction for paucibacillary (PB) leprosy in the SDR+ arm at 1 year. Of all new cases, 33.6% appeared within 8-12 weeks after BCG vaccination. CONCLUSIONS: In the first year, SDR after BCG vaccination reduced the incidence of PB leprosy among contacts by 42%. This was a statistically non-significant reduction due to the limited number of cases after SDR was administered. To what extent SDR suppresses excess leprosy cases after BCG vaccination is difficult to establish because many cases appeared before the SDR intervention. TRIAL REGISTRATION: Netherlands Trial Register: NTR3087.
RCT Entities:
OBJECTIVE: To assess the effectiveness of single-dose rifampicin (SDR) after bacillus Calmette-Guérin (BCG) vaccination in preventing leprosy in contacts. METHODS: This was a single-centre, cluster-randomized controlled trial at a leprosy control programme in northwest Bangladesh. Participants were the 14988 contacts of 1552 new leprosypatients who were randomized into the SDR-arm (n=7379) and the SDR+arm (n=7609). In the intervention group, BCG vaccination was followed by SDR 8-12 weeks later. In the control group, BCG vaccination only was given. Follow-up was performed at 1year and 2 years after intake. The main outcome measure was the occurrence of leprosy. RESULTS: The incidence rate per 10000 person-years at risk was 44 in the SDR-arm and 31 in the SDR+arm at 1year; the incidence rate was 34 in the SDR-arm and 41 in the SDR+arm at 2 years. There was a statistically non-significant (p=0.148; 42%) reduction for paucibacillary (PB) leprosy in the SDR+ arm at 1 year. Of all new cases, 33.6% appeared within 8-12 weeks after BCG vaccination. CONCLUSIONS: In the first year, SDR after BCG vaccination reduced the incidence of PB leprosy among contacts by 42%. This was a statistically non-significant reduction due to the limited number of cases after SDR was administered. To what extent SDR suppresses excess leprosy cases after BCG vaccination is difficult to establish because many cases appeared before the SDR intervention. TRIAL REGISTRATION: Netherlands Trial Register: NTR3087.
Authors: Maria Tió-Coma; Charlotte Avanzi; Els M Verhard; Louise Pierneef; Anouk van Hooij; Andrej Benjak; Johan Chandra Roy; Marufa Khatun; Khorshed Alam; Paul Corstjens; Stewart T Cole; Jan Hendrik Richardus; Annemieke Geluk Journal: Front Microbiol Date: 2020-06-16 Impact factor: 5.640
Authors: Caroline A Bulstra; David J Blok; Khorshed Alam; C Ruth Butlin; Johan Chandra Roy; Bob Bowers; Peter Nicholls; Sake J de Vlas; Jan Hendrik Richardus Journal: Infect Dis Poverty Date: 2021-03-22 Impact factor: 4.520