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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL059832-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment | Placebo Comparator | Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy |
|
| Aerosol Interferon-gamma | Experimental | Aerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide |
|
| Subcutaneous Interferon-Gamma | Experimental | Subcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerosol Interferon-Gamma | Drug | Participants will receive aerosol interferon-gamma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sputum Conversion | Measured at 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Chest Cavity Size | 16 Weeks | |
| Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels | 16 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Rom, MD, MPH | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU School of Medicine | New York | New York | 10016 | United States | ||
| The Lung Institute at University of Cape Town |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19753300 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DOTS Control Group | DOTS Control Group IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy. |
| FG001 | Aerosol Interferon Gamma for TB | Aerosol Interferon-Gamma Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma. |
| FG002 | Subcutaneous Interferon Gamma for TB | Subcutaneous Interferon-Gamma Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Demographic information provided for all subjects who were eligible for the study after all screening procedures were performed. 7 subjects who were found to be ineligible after randomization but prior to administration of treatment (listed as "did not meet continuation criteria" in participant flow section) are not included in baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | DOTS Control Group | IRPE Anti-Tuberculous Therapy IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy. |
| BG001 | Aerosol Interferon Gamma for TB |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sputum Conversion | Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment. | Posted | Number | percentage of participants | Measured at 16 Weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DOTS Control Group | DOTS Control Group IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hemoptysis | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Rom MD | NYU School of Medicine | 212 263-6479 | William.Rom@nyumc.org |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D000386 | AIDS-Related Complex |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Subcutaneous interferon-gamma | Drug | Patients will receive subcutaneous interferon-gamma |
|
| Placebo | Other |
|
| Cape Town |
| South Africa |
Aerosol Interferon-Gamma
Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma.
| BG002 | Subcutaneous Interferon Gamma for TB | Subcutaneous Interferon-Gamma Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subcutaneous Interferon-Gamma Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma. |
|
|
| Secondary | Chest Cavity Size | Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment. | Posted | Mean | Standard Deviation | millimeters | 16 Weeks |
|
|
|
| Secondary | Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels | Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment. | Posted | Median | Inter-Quartile Range | cells/mL | 16 Weeks |
|
|
|
| 1 |
| 30 |
| 0 |
| 30 |
| EG001 | Aerosol Interferon Gamma for TB | Aerosol Interferon-Gamma Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma. | 3 | 32 | 0 | 32 |
| EG002 | Subcutaneous Interferon Gamma for TB | Subcutaneous Interferon-Gamma Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma. | 3 | 27 | 0 | 27 |
| Desaturation on BAL | Respiratory, thoracic and mediastinal disorders |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders |
|
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
|
|
| Machrophages Week 0 |
|
| Machrophages Week 16 |
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| Neutrophils Week 0 |
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| Neutrophils Week 16 |
|