Clinical Trial: Molecular Epidemiology of Leprosy - Philippines

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Molecular Epidemiology of Leprosy - Philippines

Brief Summary: 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.

Detailed Summary: 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 inf
Sponsor: Colorado State University

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Information By: Colorado State University

Dates:
Date Received: April 17, 2006
Date Started: April 2006
Date Completion:
Last Updated: June 22, 2011
Last Verified: June 2011