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NCT06222372: INDIGO#2
Novel Interventions and Diagnostic Tests for Leprosy
NA trial testing Rifampin in Leprosy in 1,100 participants. Currently enrolling.
1 June 2026
Quick facts
| Lead sponsor | Annemieke Geluk |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 1,100 |
| Start date | 4 March 2020 |
| Primary completion | 1 June 2026 |
| Estimated completion | 15 December 2026 |
| Sites | 1 location across Bangladesh |
Drugs / interventions tested
- Rifampin — full drug profile →
Conditions studied
- Leprosy — all drugs for Leprosy →
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):
-
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 -
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:
- PubMed search for NCT06222372
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rifampin
Trials testing the same drug.
- NCT07357610 — An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healt · Phase 1 · recruiting
- NCT07242781 — A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult M · Phase 1 · recruiting
- NCT07018635 — A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Adm · Phase 1 · completed
- NCT06701136 — Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults · Phase 1 · not yet recruiting
- NCT06917495 — Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis · Phase 2 · not yet recruiting
Other recruiting trials for Leprosy
Currently open trials in the same condition.
- NCT07515989 — Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnos · NA · recruiting
- NCT06761469 — Leprosy Active Searching Trial in Brazil · NA · recruiting
- NCT06819449 — Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients · NA · recruiting
- NCT06683690 — TGF β 1 Expression Related Gene Polymorphism · recruiting
- NCT05597280 — Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06222372 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Annemieke Geluk
- Last refreshed: 10 September 2025
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