Molecular Epidemiology of Leprosy - Philippines

NCT00315809 | Completed

• 1 other identifier: 05-0080
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Leprosy

Keywords

leprosy, Philippines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Colorado State University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Leonard Wood Memorial Center

Cebu City, 6014, Philippines

Location

Related Publications (2)

• Kimura M, Sakamuri RM, Groathouse NA, Rivoire BL, Gingrich D, Krueger-Koplin S, Cho SN, Brennan PJ, Vissa V. Rapid variable-number tandem-repeat genotyping for Mycobacterium leprae clinical specimens. J Clin Microbiol. 2009 Jun;47(6):1757-66. doi: 10.1128/JCM.02019-08. Epub 2009 Apr 22.

  PMID: 19386839 BACKGROUND

• Sakamuri RM, Kimura M, Li W, Kim HC, Lee H, Kiran MD, Black WC 4th, Balagon M, Gelber R, Cho SN, Brennan PJ, Vissa V. Population-based molecular epidemiology of leprosy in Cebu, Philippines. J Clin Microbiol. 2009 Sep;47(9):2844-54. doi: 10.1128/JCM.02021-08. Epub 2009 Jul 1.

  PMID: 19571027 RESULT

MeSH Terms

Conditions

Leprosy

Condition Hierarchy (Ancestors)

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

Study Officials

• Varalakshmi D Vissa, PhD

  Colorado State University

  STUDY DIRECTOR

• Maria Felicio-Balagon, MD

  Leonard Wood Memorial, Cebu, Phillippines

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 17, 2006
• First Posted: April 19, 2006
• Study Start: April 1, 2006
• Study Completion: December 1, 2010
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

PH (1)