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NCT02225158 · ClinicalTrials.gov registry record
Immune Responses to Mycobacterium Tuberculosis (Mtb) in People With Latent Tuberculosis Infection With or Without Concomitant Helminth Infection
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- 1
- Enrollment target
NCT02225158 is a clinical trial that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1 participants.
The verdict
NCT02225158 was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- 1 participants
- Enrollment target
Study Summary
Background: Tuberculosis (TB) is a severe disease and a major cause of death in many people worldwide. It is caused by a bacteria that enters through the lungs and can spread elsewhere in the body. People with latent TB have the bacteria that lie dormant but can become active and cause disease. These people are offered treatment to prevent development of active TB. Worldwide, a lot of people with LTBI also have a parasitic worm called a helminth that can stay in the gut or the blood. These parasites can affect the immune system and cause diseases like TB to become worse. Researchers want to see how helminth infection makes it harder for people to fight TB infection. Objectives: \- To study how the immune system of people with latent tuberculosis infection (LTBI) acts to prevent development of active TB. Also, to study how helminth infection might affect this immune response. Eligibility: * Adults age 18 70 with LTBI as defined by an approved blood test called QuantiFERON TB Gold. * No evidence of infections like Hepatitis or HIV * Pregnant subjects and subjects taking medications that suppress the immune system are not eligible. * Have not received prior treatment for LTBI. Participants might be still eligible if prior treatment for active TB has been received Design: Screening phase: \- Participants will be screened with medical history, physical exam, and blood tests for other infections/conditions which might affect the immune system. They will have testing for active TB i.e. blood testing as well as testing of their spit, scans and X-rays. Baseline phase: * Only eligible participants will be entered into the study. * Participants will have interviews, medical history, and physical exam. * Blood will be drawn from an arm vein for testing. * Participants will collect stool samples at home for 3 days in a row to test for helminth infection.. * Participants may have apheresis. Blood cells are removed by needle. They pass through a separator machine which r
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2014-08-15 |
| Est. Completion | 2017-05-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02225158
The ClinicalTrials.gov registry entry for NCT02225158 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT02225158 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02225158 about?
NCT02225158 is a clinical study titled "Immune Responses to Mycobacterium Tuberculosis (Mtb) in People With Latent Tuberculosis Infection With or Without Concomitant Helminth Infection". Background: Tuberculosis (TB) is a severe disease and a major cause of death in many people worldwide. It is caused by a bacteria that enters through the lungs and can spread elsewhere in the body. People with latent TB have the bacteria that lie dormant but can become active and cause disease. The...
What is the current status of trial NCT02225158?
This trial is currently terminated. The enrollment target is 1 participants. The study started on 2014-08-15. Estimated completion is 2017-05-11.
Who is sponsoring clinical trial NCT02225158?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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