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NCT00257907 · ClinicalTrials.gov registry record

Immune Response to Mycobacterium Tuberculosis Infection

A clinical trial of Latent Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
157
Enrollment target
2
Study locations

NCT00257907: Completed study of Latent Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00257907 is a study of Latent Tuberculosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 157 participants, below the 1,174-participant average among 5 other Latent Tuberculosis trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00257907, a study of Latent Tuberculosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
157 participants
Enrollment target
2
Study locations

Study Summary

This study will examine how the immune system responds to infection with Mycobacterium tuberculosis bacteria (bacteria that cause tuberculosis) in order to better understand how the germ produces infection and how the immune response might work to control the infection. Only about one in 10 people infected by M. tuberculosis become sick, sometimes years or even decades after exposure. It is not known why some people become sick and most do not, but the immune system of people who never develop disease may be better able to control the bacteria. This study will evaluate the latent form of M. tuberculosis infection to further the understanding of the immune mechanisms - particularly the role of certain white blood cells - involved in the disease process. Healthy volunteers 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, family history of medical conditions, sexual history, history of drug use, physical examination and blood tests, including a test for HIV. People in Mali, West Africa, and in local health clinics in the United States may participate. At the start of the study, participants have blood tests and a tuberculin skin test (PPD test), which indicates whether a person has been exposed to tuberculosis bacteria. For the PPD, a tiny amount of liquid containing dead tuberculosis antigen is put under the skin of the forearm with a needle. The antigen cannot cause infection or disease. After 3 days, participants have another blood test and the site of the tuberculin test is examined for swelling that would indicate a positive result. Participants with a positive PPD have a chest x-ray to check for tuberculosis disease. Those whose x-ray is also positive are withdrawn from the study and referred to their doctor for evaluation and treatment. Those whose x-ray is negative return to the clinic within 3 weeks of the tuberculin test to give another blood sample. Participants whose PPD is negative have a second

Conditions Studied

Study Locations (2)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Other

  • Mali-NIAID HIV Research Initiative FMPOS - Bamako

Trial Details

FieldValue
Enrollment Target 157 participants
Start Date 2005-11-18
Est. Completion 2016-02-24

What the finished NCT00257907 record still lists

NCT00257907 is an observational study that tracks outcomes without assigning an intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, below the 1,174-participant average among 5 other Latent Tuberculosis trials with a reported enrollment target (87% lower).

The record links to 1 condition, with Latent Tuberculosis appearing as the primary indexed condition, and to 0 interventions.

NCT00257907 reports a single indexed study location in Maryland, Other.

Frequently Asked Questions

What is clinical trial NCT00257907 about?

NCT00257907 is a clinical study titled "Immune Response to Mycobacterium Tuberculosis Infection". This study will examine how the immune system responds to infection with Mycobacterium tuberculosis bacteria (bacteria that cause tuberculosis) in order to better understand how the germ produces infection and how the immune response might work to control the infection. Only about one in 10 people ...

What is the current status of trial NCT00257907?

This trial is currently completed. The enrollment target is 157 participants. The study started on 2005-11-18. Estimated completion is 2016-02-24.

What conditions does trial NCT00257907 study?

This clinical trial studies the following conditions: Latent Tuberculosis.

Who is sponsoring clinical trial NCT00257907?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00257907 being conducted?

This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00257907, the US trial registry maintained by the National Library of Medicine. NCT00257907 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.