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NCT06222372: INDIGO#2

Novel Interventions and Diagnostic Tests for Leprosy

Recruiting now NA Last updated 10 September 2025
What this trial tests

NA trial testing Rifampin in Leprosy in 1,100 participants. Currently enrolling.

Timeline
4 March 2020
Primary endpoint
1 June 2026
15 December 2026

Quick facts

Lead sponsorAnnemieke Geluk
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment1,100
Start date4 March 2020
Primary completion1 June 2026
Estimated completion15 December 2026
Sites1 location across Bangladesh

Drugs / interventions tested

Conditions studied

Sponsor

Annemieke Geluk

Who can join

5 and older, any sex, with Leprosy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Contact with Mycobacterium leprae (M. leprae) infected individuals is a risk factor for development of leprosy. Thus, detection of asymtomatically M. leprae infected individuals, allowing informed decision making on who needs treatment at a preclinical stage, is vital to interrupt transmission and can help prevent leprosy. In a previous field trial the BCG vaccine was applied alone and combined with a single dose of rifampin (SDR) as prophylactic interventions in contacts of leprosy patients in Bangladesh. Concurrently, blood-derived host immune-profiles specific for M. leprae infection or leprosy disease were assessed in the same population by merging detection of innate, adaptive cellular as well as humoral immunity. This has led to the identification of selected host-immune markers, currently applied in a low complexity lateral flow assay based on up-coverting particles (UCP-LFA), providing a convenient tool to assess M. leprae infection, allowing assessment of efficacy of prophylactic interventions in a point-of-care setting. The proposed study aims to determine the effect of post-exposure prophylaxis by SDR on M. leprae infection rate using UCP-LFA before and after prophylaxis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Rapid test for Mycobacterium leprae infection: a practical tool for leprosy.
    Pierneef L, van Hooij A, de Jong D, Wassenaar G, et al · · 2024 · cited 10× · PMID 39617937 · DOI 10.1186/s40249-024-01262-9
  2. Large-scale field application of a fingerstick blood test for Mycobacterium leprae infection: Monitoring population-wide effects of case finding and post-exposure prophylaxis on transmission in the Comoros and Madagascar.
    Pierneef L, Braet SM, de Jong D, Ramboarina S, et al · · 2025 · cited 1× · PMID 41329688 · DOI 10.1371/journal.pgph.0005270

Verify or expand the search:

Other trials of Rifampin

Trials testing the same drug.

Other recruiting trials for Leprosy

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06222372.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing