Immune Responses to Mycobacterium Tuberculosis (Mtb) in People With Latent Tuberculosis Infection With or Without Concomitant Helminth Infection

Stopped early

Conditions studied: Latent Tuberculosis Infection

In brief

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 returns everything but the cells back to the participant. * Participants may have procedures at the start and end of the study that let researchers look into the lungs and collect cells. Study phase, about 2 years: * All participants will be offered treatment for LTBI which lasts 6-9 months. * Participants being treated for LTBI will have about 11 study visits. They will visit monthly for 9 months while on treatment, then 6 and 12 months after treatment. * Participants not eligible/refusing treatment for LTBI will be made aware of active TB, then have 3 other visits, about 6, 12, and 24 months after the baseline visit. * Participants who have helminth infection will receive appropriate treatment. * All participants will have blood drawn at each visit.

Key facts

Study ID

NCT02225158

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1

Starts

2014-08-15

Expected to finish

2017-05-11

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A subject will be excluded if they meet any of the following criteria:
• Presence of active TB disease
• Treatment for helminth infection within the past year
• Positive at screening for HIV, hepatitis B, and/or hepatitis C Cardiovascular instability (Blood pressure: Systolic >180 or <90 mm/Hg or Diastolic >100 or < 50 mm/Hg; pulse <40 or >110)
• Inadequate peripheral venous access
• Anemia (hemoglobin <11 g/dL)
• Current use of corticosteroids or other immunosuppressive agents or documented diagnosis of a primary immunodeficiency disorder
• Underlying heart disease, lung disease, bleeding disorder, or other conditions that, in the judgment of the investigator, contraindicates apheresis
• Temperature greater than or equal to 38.5 degrees C or other clinical evidence of an acute infection at screening
• Currently pregnant or breastfeeding
• A subject will not be eligible for optional bronchoscopy and bronchoalveolar lavage if they meet any of the following additional exclusion criteria:
• History of recent/acute clinically significant pulmonary compromise. This will be defined by the following criteria:
• New lung infection or change in status of chronic lung infection or significant new findings on chest X-ray or CT scan
• Asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that required the use of oral or parenteral corticosteroids during the past two years
• Clinically significant reactive airway disease that does not respond to bronchodilators
• Unstable chronic lung disease such as Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis
• History of pulmonary hypertension
• Requirement of supplemental oxygen at rest
• Unstable angina or uncontrolled heart failure or rhythm disturbance
• Significant kidney or liver disease
• Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), significant bruising or bleeding difficulties with IM injections or blood draws, or use of anticoagulant medications
• Use of platelet inhibitors including aspirin and NSAIDs within 7 days of procedure or clopidogrel (Plavix [TM]) within 14 days of procedure or the inability to safely stop platelet inhibitors for 7-14 days prior to procedures
• History of allergic reaction to lidocaine, sedative medications like Valium(TM) or Versed (TM), or narcotic medications like morphine or fentanyl
• Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to bronchoscopy and bronchoalveolar lavage or impairs a volunteer s ability to give informed consent for the procedure

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Montgomery County Public Health Services, TB, Refugee and Migrant Health — Silver Spring, Maryland, United States

Full record on ClinicalTrials.gov

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