Actively Recruiting

Phase Not Applicable
Age: 5Years +
All Genders
Healthy Volunteers
ID06222372

Monitoring the Effect of Prophylactic Interventions in Contacts of Leprosy Patients Including Field-application of a Novel Immunodiagnostic Test in Bangladesh

Led by Annemieke Geluk · Updated on 2025-09-10

1100

Participants Needed

1

Research Sites

28 weeks

Total Duration

On this page

Sponsors

A

Annemieke Geluk

Lead Sponsor

T

The Leprosy Mission Bangladesh

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating new ways to prevent leprosy by focusing on people who have been in contact with individuals infected by Mycobacterium leprae. The study evaluates the effect of a single dose or a double dose of the antibiotic rifampin given after exposure to prevent infection. It also uses a new, simple blood test called UCP-LFA to detect signs of infection early, helping to guide treatment decisions and potentially stop the spread of the disease in communities where leprosy remains common. The trial compares two dosing strategies of rifampin given to household contacts and close neighbors of newly diagnosed leprosy patients. Adults and children 5 years and older receive either a single dose or a double dose of rifampin adjusted by weight. The study uses the UCP-LFA test to measure immune markers related to M. leprae infection before and after the treatment to assess changes. This approach aims to improve early detection and prevention efforts in field settings. Participants are monitored through blood samples taken before and at 2 weeks, 4 weeks, and 6 months after receiving rifampin. These samples help track changes in immune proteins and bacterial load to evaluate the impact of the prophylactic treatment. The study involves regular follow-ups to assess effectiveness and safety, with a focus on practical, point-of-care testing methods that can be used widely in endemic areas. The total duration of participant involvement spans at least 6 months after intervention.

CONDITIONS

Brief Title

Novel Interventions and Diagnostic Tests for Leprosy

Who Can Participate

Age: 5Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed multibacillary leprosy patients (bacterial index 1-6)
  • Contacts living in the same house (household members)
  • Contacts living in a house on the same compound
  • Contacts sharing the same kitchen
  • Direct neighbors (first neighbors)
  • Willing to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • Refusal to allow examination of contacts
  • Having pure neural form of leprosy
  • Residing only temporarily in the study area
  • Having paucibacillary leprosy
  • Contacts diagnosed as leprosy patients during examination
  • Contacts living less than 100 meters from a patient already in the study
  • First and second degree relatives of a patient already included in the study
  • Refusal to provide informed consent
  • Pregnancy
  • Currently receiving tuberculosis or leprosy treatment
  • Younger than 5 years old
  • Known liver disease or jaundice
  • Residing temporarily in the study area

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single dose administration

Participants receive a single dose or single double dose of rifampin for prevention of leprosy following exposure.

1 treatment visit (in-person)

Monitoring

Duration - 6 months

Participants are monitored for changes in host serum proteins and bacterial load after rifampin administration.

3 visits at 2 weeks, 4 weeks, and 6 months post-treatment (in-person)

Trial Site Locations

Total: 1 location

1

The Leprosy Mission International - Bangladesh

Nilphamari, Bangladesh, 5300

Actively Recruiting

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Research Team

A

Annemieke Geluk, PhD

A

Anouk van Hooij, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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