Rapid Characterization of Paucibacillary TB Along Tex/Mex Border

NCT00421798 | Completed

• 1 other identifier: 06-0042 transfer from DMID
• Study Type: observational
• Target: 780
• Locations: 3 countries
• Sites: 3

Brief Summary

This study will test a method of detecting tuberculosis-causing bacteria that are resistant to current medication treatments. Blood samples will be collected from patients from 3 sites and 3 mainly Hispanic populations in Texas, Mexico, and Colombia. Up to 780 males and females, ages 18-85 years, will participate. The study population will consist of 390 people with any of 3 forms of tuberculosis (TB) and 390 people who are either healthy or with a disease initially thought to be one of these 3 forms of TB but then ruled out. Volunteers will only be contacted, invited to participate and interviewed at the beginning of their evaluation for possible TB.The study team will follow up with the health department to determine if the volunteer was indeed diagnosed with TB, and with the laboratory to determine the results of TB tests at diagnosis and during the course of treatment.

Conditions

Mycobacterium Tuberculosis

Keywords

tuberculosis, paucibacillary, mycobacteria, Mexico, Colombia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Studies will be conducted in the population from the TExas-Mexico border, and in Colombia. Participants are TB suspects, or controls.

You may qualify if:

• For Cases and Controls:
• Informed consent obtained and signed
• Older than 18 years of age, up to 85 years of age
• Unique to Cases:
• Suspicion of smear-negative pulmonary tuberculosis, lymphatic tuberculosis or pleural tuberculosis
• Unique to Controls:
• Initial suspicion of tuberculosis (as described under cases) but diagnosis eventually ruled out through further testing
• Patient with another pathology where specimen similar to that collected for the cases is also obtained, and leftover material is available for this study; example- lymph node biopsy from a patient with cancer

You may not qualify if:

• Patient having received more than 14 days of anti-mycobacterial treatment
• Less than 18 years old
• Prisoner or jail inmate

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

The University of Texas at Brownsville

Brownsville, Texas, 78520, United States

Location

Corporacion para Investigaciones Biologicas de Medellin

Medellín, Colombia

Location

Jurisdicción Sanitaria III Matamoros

Matamoros, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood from participants will be collected, and DNA extracted from white blood cells. These are expected to also contain DNA from M. tuberculosis- that will be the research question

MeSH Terms

Conditions

Tuberculosis; Mycobacterium Infections

Condition Hierarchy (Ancestors)

Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Blanca Restrepo, PhD

  UT Health Science Center at Houston -School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 11, 2007
• First Posted: January 12, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 9, 2009

Record last verified: 2009-07

Locations

CO (1); US (1); ME (1)