Determining Risk in Latent Tuberculosis

NCT01571739 | Terminated

• 2 other identifiers: 99991203612-I-N036
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Tuberculosis (TB) is a leading cause of death worldwide. Those who are exposed to the TB bacteria but have not become sick are said to have latent TB. Many people with latent TB will not get sick from it, but some people will develop active TB and become sick. Much is known about how to treat and diagnose active TB, but little is known about the best way to treat latent TB. Researchers also want to know more about the risk that latent TB will develop into active TB, and whether it is possible to test for this risk. Objectives: \- To test possible methods of determining a person s risk for developing active TB. Eligibility: \- Individuals between 20 and 60 years of age who (1) have active TB, (2) were exposed to someone with active TB in the past 9 months, or (3) have not been exposed to TB. Design:

• Participants will be separated into groups based on their exposure to TB.
• Healthy participants who were not exposed to TB will answer questions about their medical history. They will also provide blood and urine samples.
• Participants who have active TB will have a physical exam and medical history. They will provide blood, urine, and sputum samples, and will have a chest x-ray. They will be treated with the standard of care for active TB. Some participants with active TB may have additional tests as part of this study.
• Participants who were exposed to TB and have latent TB will have a physical exam and medical history. They will provide blood, urine, and sputum samples, and will have a chest x-ray. They will be asked to return for five more clinic visits over the next 12 months to repeat these tests. They may also have additional chest imaging studies depending on the study needs.
• Some of the exposed participants may have been exposed to drug-resistant TB. These participants will receive the drug isoniazid to take on a regular schedule to help prevent the latent TB from becoming active TB.

Conditions

Latent Tuberculosis

Keywords

Biomarker; Latent Tuberculosis; IGRA; Isoniazid; TB Lymphadenopathy; Tuberculosis; TB

Outcome Measures

Primary Outcomes (1)

• To estimate the rate of PET plus CXR at baseline among all study participants.

Secondary Outcomes (2)

• To estimate the rate of PET+/CT- at baseline among all study participants.

• To estimate the rate of regression of PET plus scans (to normal) at 3 and 12 months among the untreated subjects (n=30).

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Either confirmed sputum smear positive and culture positive for M. tb within the last 12 months OR sputum smear positive and genotypically confirmed M.tb with culture awaited
• Age greater than or equal to 20 years old
• Smear Positive Pulmonary TB Biomarker Index Case Controls:
• Genotypically confirmed sputum smear positive pulmonary tuberculosis
• Culture awaited or confirmed Mtb
• Not commenced anti-tuberculous therapy
• Age greater than or equal to 20 years old

You may not qualify if:

• Age \>60 years old
• Known diagnosis of chronic inflammatory condition (e.g. Sarcoid, RA, connective tissue disorder) or on immunosuppressive medication
• WITHDRAWAL CRITERIA:
• \) Culture negative for M.tb
• QF-GIT Positive Contacts:
• Contacts of index case
• QF-GIT positive
• Age greater than or equal to 20 years old
• Normal CXR
• Exposure to an index case who commenced treatment for a current episode of TB (one that was not successfully treated, per WHO definition) more than 15 months ago
• Previously diagnosed or treated TB
• Symptoms or signs of active TB
• Symptoms or signs of acute illness
• CXR suggestive of active tuberculosis or parenchymal abnormalities known or suspected to be caused by alternative pathology
• HIV positive or other significant immunocompromise

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Medical Center

Seoul, South Korea

Location

Related Publications (3)

• Banura C, Mirembe FM, Katahoire AR, Namujju PB, Mbonye AK, Wabwire FM. Epidemiology of HPV genotypes in Uganda and the role of the current preventive vaccines: A systematic review. Infect Agent Cancer. 2011 Jul 12;6(1):11. doi: 10.1186/1750-9378-6-11.

  PMID: 21749691 BACKGROUND

• Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsague X, Rusche SA, Lukac S, Bryan JT, Cavanaugh PF Jr, Reisinger KS; Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006 Nov;118(5):2135-45. doi: 10.1542/peds.2006-0461.

  PMID: 17079588 BACKGROUND

• Centers for Disease Control and Prevention (CDC). National, state, and local area vaccination coverage among adolescents aged 13-17 years --- United States, 2009. MMWR Morb Mortal Wkly Rep. 2010 Aug 20;59(32):1018-23.

  PMID: 20724968 BACKGROUND

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Clifton E Barry, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 5, 2012
• Study Start: January 2, 2012
• Study Completion: May 20, 2014
• Last Updated: November 25, 2019

Record last verified: 2014-05-20

Locations

KR (1)