Molecular Epidemiology of Leprosy - Philippines

June 22, 2011 updated by: Colorado State University
The purpose of the study is to see if new methods can be used to determine why Multidrug Therapy (MDT), used to cure leprosy patients effectively for twenty years, is not as effective against Leprosy in the Philippines. Researchers do not know how people get infected with leprosy or what causes the disease to relapse after cure with adequate MDT. Blood, skin scrapings, nasal swabs and biopsies, will be collected from leprosy patients to perform tests related to the detection of the disease and the germ. The tests will be used to find out if the bacteria in the body are related to the bacteria found in other patients or contacts. This will help the researchers to know where these bacteria come from, and to see how they spread. Other tests will be performed to see if the bacteria can be killed by two common medicines given to leprosy patients. Study participants will include individuals age 18 and older presenting to Leonard Wood Memorial for the diagnosis and/or relapse of leprosy.

Study Overview

Status

Completed

Conditions

Detailed Description

The overall objectives of this study are to understand the factors leading to continued incidence of leprosy in the Philippines by novel molecular methodologies using a combination of retrospective and prospective sampling approaches. The overall objectives include: (1) strain typing of M. leprae isolates obtained from new and relapsed leprosy patients in the Philippines to identify clusters and transmission patterns when combined with conventional epidemiological criteria; (2) to determine the viability of M. leprae by mRNA detection in specimens collected from new patients; and those with signs of relapse; (3) to identify and determine the extent of mutations conferring resistance in past and circulating M. leprae isolates from leprosy patients to two Multidrug therapy (MDT) drugs; Dapsone and Rifampicin and; (4) to detect chains of transmission in endemic populations by a retrospective analyses of isolates in sample banks when combined with strain typing information from new cases and conventional epidemiological criteria. The following are the outcome measures for each of the objectives: (1) strain typing: identification of genotypes; (2) percent of samples from patients and their contacts containing viable M. leprae (as judged by the presence of mRNA for a panel of M. leprae genes; (3) percent of samples from patients and their contacts containing mutations in M. leprae rpoB and folP 1 genes and identification of new mutations associated with relapse and; (4) identification of matching or similar genotypes in new samples obtained from patients and their household contacts with those in retrospective samples. Clinical specimens that contain M. leprae bacilli such as skin biopsy, slit skin smears, nasal swabs and blood are required to obtain M. leprae DNA to meet the objectives of the study. Nasal swabs will be used for assessing the role of the nasal mucosa in infection and dissemination in leprosy. The blood is useful for monitoring the humoral responses to infection. Skin biopsy, slit skin smears, nasal swabs and blood will be obtained from informed consenting patients. Enrollment and sample collection procedures will take approximately 1-2 hours. These procedures will be performed during the patient's visit to the clinic for diagnosis and therapy for leprosy. As part of the study, a punch biopsy from a lesion is being collected to enable sufficient quantities of DNA to be extracted for strain typing, a critical objective of this study. Patients will be required to visit the site once more after 7-10 days to assess the biopsy site. This visit may take 30-60 minutes. An epidemiology survey containing demographic and clinical information will be obtained from each participant. Study participants for prospective sample collections will include volunteering and consenting individuals, 18 years old and above, reporting at Leonard Wood Memorial (LWM) CebuSkin Clinic, Leonard Wood Memorial Center for Biomedical Research, Cebu, Philippines for the diagnosis of leprosy and/or relapse of leprosy.

Study Type

Observational

Enrollment (Actual)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Cebu City, Philippines, 6014
        • Leonard Wood Memorial Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Blood, nasal swabs, slit skin smears and biopsies will be obtained prospectively from individuals greater than 18 years of age, representing newly diagnosed and relapse leprosy patients. The study participants will be obtained from LWM clinic. DNA and RNA based methodologies will be developed and applied to obtain data necessary for substantiation of a number of factors implicated in transmission of leprosy in Philippines.

Description

Inclusion Criteria:

1. All Leprosy patients eighteen years and above who are consulting at the LWM will be invited to participate.

Exclusion Criteria:

1. Patients unwilling to participate or unable to give informed consent will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado State University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Director: Varalakshmi D Vissa, PhD, Colorado State University
  • Principal Investigator: Maria Felicio-Balagon, MD, Leonard Wood Memorial, Cebu, Phillippines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 17, 2006

First Submitted That Met QC Criteria

April 17, 2006

First Posted (Estimate)

April 19, 2006

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-0080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leprosy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe