MedDataX Logo

Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs

NCT ID: NCT00201123

Last Updated: 2016-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

BACKGROUND:

Mtb infects one-third of the world's population and ranks seventh in terms of global morbidity and mortality. Patients with bilateral pulmonary tuberculosis (TB), cavitary disease, and persistently positive sputum smears pose a special risk for treatment failure and/or relapse.

DESIGN NARRATIVE:

Cavitary pulmonary TB will be studied and interferon-gamma will be used as the intervention. The outcome of this study will be the changes in mycobacteriology, chest radiography, and bronchoalveolar lavage (BAL) cells.

The primary outcome will be sputum conversion, which will be measured at Weeks 4 and 8.

The key secondary outcomes of this study will include a chest computerized tomography (CT) scan and BAL to measure the flow of cytometry and cytokine levels. Both outcomes will be measured at baseline and at Month 4.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis AIDS-related Complex

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard Treatment

Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Aerosol Interferon-gamma

Aerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide

Group Type EXPERIMENTAL

Aerosol Interferon-Gamma

Intervention Type DRUG

Participants will receive aerosol interferon-gamma.

Subcutaneous Interferon-Gamma

Subcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide

Group Type EXPERIMENTAL

Subcutaneous interferon-gamma

Intervention Type DRUG

Patients will receive subcutaneous interferon-gamma

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aerosol Interferon-Gamma

Participants will receive aerosol interferon-gamma.

Intervention Type DRUG

Subcutaneous interferon-gamma

Patients will receive subcutaneous interferon-gamma

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Positive acid-fast bacillus (AFB) smear within 14 days prior to randomization
* Cluster of Differentiation 4 greater than 200 if HIV positive
* Ability to sign consent
* Bilateral, cavitary pulmonary TB

Exclusion Criteria

* Multidrug-resistant (MDR) TB
* Extrapulmonary TB
* HIV positive with opportunistic infection within 30 days of study entry
* Cancer
* Asthma
* Pregnant or lactating women
* Chronic heart disease
* Chronic liver disease
* Chronic renal disease
* Seizure disorder
* Bleeding or clotting disorder
* Diabetes mellitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

William Rom, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NYU School of Medicine

New York, New York, United States

Site Status

The Lung Institute at University of Cape Town

Cape Town, , South Africa

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States South Africa

References

Explore related publications, articles, or registry entries linked to this study.

Dawson R, Condos R, Tse D, Huie ML, Ress S, Tseng CH, Brauns C, Weiden M, Hoshino Y, Bateman E, Rom WN. Immunomodulation with recombinant interferon-gamma1b in pulmonary tuberculosis. PLoS One. 2009 Sep 15;4(9):e6984. doi: 10.1371/journal.pone.0006984.

Reference Type RESULT
PMID: 19753300 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HL059832-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

264

Identifier Type: -

Identifier Source: org_study_id