02343nas a2200229 4500000000100000008004100001100001600042700001100058700001200069700001100081700001200092700001600104700001400120700001200134700001400146700001200160700001700172245018400189856006500373520166100438022001402099 2019 d1 aRichardus R1 aAlam K1 aKundu K1 aRoy JC1 aZafar T1 aChowdhury A1 aNieboer D1 aFaber R1 aButlin CR1 aGeluk A1 aRichardus JH00aEffectiveness of single dose rifampicin after BCG-vaccination to prevent leprosy in close contacts of patients with newly diagnosed leprosy: a cluster randomized controlled trial. uhttps://www.ijidonline.com/article/S1201-9712(19)30365-0/pdf3 a

OBJECTIVE: To assess the effectiveness of SDR after BCG-vaccination in preventing leprosy in contacts.

DESIGN: Single-centre, cluster-randomized controlled trial.

SETTING: Leprosy control programme in northwest Bangladesh.

PARTICIPANTS: 14,988 contacts of 1,552 new leprosy patients; randomized in the SDR- arm (7,379) and SDR + arm (7,609).

INTERVENTIONS: Intervention group: BCG-vaccination followed by SDR 8-12 weeks later.

CONTROL GROUP: BCG only.

FOLLOW-UP: at one and two years after intake.

MAIN OUTCOME MEASURE: The occurrence of leprosy.

RESULTS: The incidence rate per 10,000 person-years-at-risk was 44 in the SDR- arm and 31 in the SDR + at 1 year, and 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 PB leprosy in the SDR + arm at 1 year. Of all new cases, 33.6% appeared within 8-12 weeks after BCG-vaccination.

CONCLUSION: In the first year, SDR after BCG-vaccination reduced PB leprosy incidence among contacts by 42%. This was a statistically non-significant reduction due to the limited number of cases after SDR was administered. To which extent SDR suppresses excess leprosy cases after BCG-vaccination is difficult to establish because many appeared before the SDR intervention.

TRIAL REGISTRATION: Netherlands Trial Register: NTR3087.

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