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Understanding Drug Resistance in Leprosy: A Study on Patients in Gujarat

An analytical cross-sectional multicentric study for detection of Antimicrobial drug resistance and viability through mutational study in Hansen s disease among patients in Gujarat. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/085575
Enrollment
80
Registered
2025-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue

Interventions

Intervention1: NIL: NIL

Sponsors

IADVL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All newly diagnosed treatment-naive cases of all age groups and both sex with a clinical diagnosis of leprosy according to Indian Classification, who on slit skin smear or Biopsy display a bacillary index 0-6. RFT cases of Hansen s with signs of Relapse, Reinfection, or recurrent ENL leprosy with a bacillary index 0-6. Patients willing to participate and provide informed consent in the study. Severely ill patients with leprosy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Detection of Antimicrobial Resistance (AMR): Identification of drug resistance mutations in Mycobacterium leprae using SNP (Single Nucleotide Polymorphism) analysis. Assessment of resistance to key anti-leprosy drugs (e.g., dapsone, rifampicin, and ofloxacin) in leprosy patientsTimepoint: 2 year

Secondary

MeasureTime frame
Viability of M. leprae Post-Treatment: Evaluation of the persistence of viable M. leprae in patients after completion of Multidrug Therapy (MDT) using Molecular Viability Assay (MVA). Comparative Histopathological Study of Leprosy in Gujarat: Examination of the histopathological spectrum of leprosy cases to identify variations in clinical presentation, disease progression, and response to treatment.Timepoint: 2 year

Countries

India

Contacts

Public ContactAnkit Hemantkumar Bharti

Dr. Ankit Bharti s dermatopathology research centre Pvt. Ltd.

dr.ankithbharti@gmail.com7600418578

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026