Novel Interventions and Diagnostic Tests for Leprosy

NCT06222372 | Recruiting

• 1 other identifier: INDIGO#2
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leprosy

Keywords

leprosy, diagnostics, SDR, post exposure prophylaxis (PEP), biomarkers, UCP-LFA

Outcome Measures

Primary Outcomes (2)

• Changes of levels of host serum proteins in contacts after SDR

  Using UCP-LFA levels of biomarkers will be quantified in fingerprick blood samples

  samples will be analysed 2 weeks, 4 weeks, and 6 months after SDR

• Changes of levels of host serum proteins in contacts after SDDR

  Using UCP-LFA levels of biomarkers will be quantified in fingerprick blood samples

  samples will be analysed 2 weeks, 4 weeks, and 6 months after SDDR

Secondary Outcomes (2)

• Changes in bacterial load in contacts after SDR

  samples will be analysed 2 weeks, 4 weeks, and 6 months after SDR

• Changes in bacterial load in contacts after SDDR

  samples will be analysed 2 weeks, 4 weeks, and 6 months after SDDR

Study Arms (2)

Single dose rifampin (SDR)

EXPERIMENTAL

To household contacts of newly diagnosed leprosy patients SDR is provided as follows: 600 mg rifampicin for adults weighing 35 kg and over, 450 mg for adults weighing less than 35 kg and for children older than 9 years, and 300 mg for children aged 5 to 9 years.

Drug: Rifampin

Single double dose rifampin (SDDR)

EXPERIMENTAL

To household contacts of newly diagnosed leprosy patients SDDR is provided as follows: 1200 mg rifampicin for adults weighing 35 kg and over, 900 mg for adults weighing less than 35 kg and for children older than 9 years, and 600 mg for children aged 5 to 9 years.

Drug: Rifampin

Interventions

Rifampin DRUG

antibiotic

Single dose rifampin (SDR); Single double dose rifampin (SDDR)

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- newly diagnosed multibacillary leprosy patients (BI 1-6)
• living in the same house (household members)
• living in a house on the same compound
• sharing the same kitchen
• direct neighbors (first neighbors)
• willing to participate
• provide informed consent

You may not qualify if:

• refusal of examination of their contacts
• suffering from the pure neural form of leprosy
• residing only temporarily in the study area
• PB leprosy patients
• diagnosed as leprosy patients during contact examination
• living less than 100 m away from a patient already included in the study
• first and second degree relatives of a patient already included in the study
• refusal informed consent
• pregnancy
• tuberculosis or leprosy treatment
• below 5 years of age
• known to suffer from liver disease or jaundice
• residing temporarily in the study area

Sponsors & Collaborators

• Annemieke Geluk: lead
• The Leprosy Mission Bangladesh: collaborator

Study Sites (1)

The Leprosy Mission International - Bangladesh

Nilphamari, 5300, Bangladesh

RECRUITING

MeSH Terms

Conditions

Leprosy

Interventions

Rifampin

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Annemieke Geluk, PhD

  Academisch Ziekenhuis Leiden (LUMC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annemieke Geluk, PhD

CONTACT

+31715261974; ageluk@lumc.nl

Anouk van Hooij, PhD

CONTACT

+31715263844; A.van_Hooij@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: As an additional feature of this sub-study, we will test two SDR regimens. One regimen will be the until now standard SDR regimen of 600 mg rifampicin for adults weighing 35 kg and over, 450 mg for adults weighing less than 35 kg and for children older than 9 years, and 300 mg for children aged 5 to 9 years. The other regimen will be double this dose (1200 mg rifampicin for adults weighing 35 kg and over, 900 mg for adults weighing less than 35 kg and for children older than 9 years, and 600 mg for children aged 5 to 9 years). The patients and their contact group will be equally allocated through randomization to one of the two SDR regimen groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Annemieke Geluk

Model Details: Contacts of new MB leprosy patients with a bacterial index (BI) of 2 or more will be included. To determine the effect of SDR on M. leprae infection rate using UCP-LFA prospectively, SDR will be administered to 10 contacts of the new leprosy patients (n=100). M. leprae infection will be determined for each patient and contact by finger stick UCP-LFA for multiplex detection of anti-M. leprae antibodies and cytokines at time points 0 (intake), 2 weeks, 4 weeks, and 6 months after SDR (n=4,400). Contacts will include both household and neighbor contacts.

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 24, 2024
• Study Start: March 4, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)