Trial Outcomes & Findings for Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs (NCT NCT00201123)
NCT ID: NCT00201123
Last Updated: 2016-12-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Measured at 16 Weeks
Results posted on
2016-12-16
Participant Flow
Participant milestones
| Measure |
DOTS Control Group
DOTS Control Group
IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy.
|
Aerosol Interferon Gamma for TB
Aerosol Interferon-Gamma
Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma.
|
Subcutaneous Interferon Gamma for TB
Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma.
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
32
|
|
Overall Study
Did Not Meet Continuation Criteria
|
2
|
0
|
5
|
|
Overall Study
COMPLETED
|
26
|
28
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Baseline characteristics by cohort
| Measure |
DOTS Control Group
n=30 Participants
IRPE Anti-Tuberculous Therapy
IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy.
|
Aerosol Interferon Gamma for TB
n=32 Participants
Aerosol Interferon-Gamma
Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma.
|
Subcutaneous Interferon Gamma for TB
n=27 Participants
Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 11 • n=5 Participants
|
34 years
STANDARD_DEVIATION 10 • n=7 Participants
|
35 years
STANDARD_DEVIATION 13 • n=5 Participants
|
34 years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Gender
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Gender
Male
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
30 participants
n=5 Participants
|
32 participants
n=7 Participants
|
27 participants
n=5 Participants
|
89 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at 16 WeeksPopulation: Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.
Outcome measures
| Measure |
DOTS Control Group
n=30 Participants
IRPE Anti-Tuberculous Therapy
IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy.
|
Aerosol Interferon Gamma for TB
n=32 Participants
Aerosol Interferon-Gamma
Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma.
|
Subcutaneous Interferon Gamma for TB
n=27 Participants
Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma.
|
|---|---|---|---|
|
Sputum Conversion
|
36 percentage of participants
|
60 percentage of participants
|
36 percentage of participants
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.
Outcome measures
| Measure |
DOTS Control Group
n=32 Participants
IRPE Anti-Tuberculous Therapy
IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy.
|
Aerosol Interferon Gamma for TB
n=30 Participants
Aerosol Interferon-Gamma
Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma.
|
Subcutaneous Interferon Gamma for TB
n=27 Participants
Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma.
|
|---|---|---|---|
|
Chest Cavity Size
Baseline
|
34 millimeters
Standard Deviation 11
|
39 millimeters
Standard Deviation 24
|
34 millimeters
Standard Deviation 13
|
|
Chest Cavity Size
16 Weeks
|
20 millimeters
Standard Deviation 16
|
29 millimeters
Standard Deviation 24
|
18 millimeters
Standard Deviation 17
|
SECONDARY outcome
Timeframe: 16 WeeksPopulation: Intention to Treat analysis performed. Only subjects excluded were those who did not receive treatment.
Outcome measures
| Measure |
DOTS Control Group
n=30 Participants
IRPE Anti-Tuberculous Therapy
IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy.
|
Aerosol Interferon Gamma for TB
n=32 Participants
Aerosol Interferon-Gamma
Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma.
|
Subcutaneous Interferon Gamma for TB
n=27 Participants
Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma.
|
|---|---|---|---|
|
Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
Lymphocytes Week 0
|
4 cells/mL
Interval 2.0 to 8.0
|
5 cells/mL
Interval 3.0 to 15.0
|
6 cells/mL
Interval 3.0 to 10.0
|
|
Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
Lymphocytes Week 16
|
15 cells/mL
Interval 6.0 to 25.0
|
15 cells/mL
Interval 8.0 to 34.0
|
22 cells/mL
Interval 13.0 to 33.0
|
|
Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
Machrophages Week 0
|
60 cells/mL
Interval 17.0 to 84.0
|
60 cells/mL
Interval 32.0 to 80.0
|
62 cells/mL
Interval 43.0 to 83.0
|
|
Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
Machrophages Week 16
|
64 cells/mL
Interval 44.0 to 72.0
|
63 cells/mL
Interval 40.0 to 84.0
|
66 cells/mL
Interval 54.0 to 77.0
|
|
Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
Neutrophils Week 0
|
28 cells/mL
Interval 10.0 to 82.0
|
24 cells/mL
Interval 5.0 to 56.0
|
30 cells/mL
Interval 4.0 to 54.0
|
|
Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
Neutrophils Week 16
|
11 cells/mL
Interval 3.0 to 31.0
|
4 cells/mL
Interval 2.0 to 16.0
|
2 cells/mL
Interval 2.0 to 9.0
|
Adverse Events
DOTS Control Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Aerosol Interferon Gamma for TB
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Subcutaneous Interferon Gamma for TB
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DOTS Control Group
n=30 participants at risk
DOTS Control Group
IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy.
|
Aerosol Interferon Gamma for TB
n=32 participants at risk
Aerosol Interferon-Gamma
Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma.
|
Subcutaneous Interferon Gamma for TB
n=27 participants at risk
Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
3.3%
1/30
|
0.00%
0/32
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Desaturation on BAL
|
0.00%
0/30
|
6.2%
2/32
|
7.4%
2/27
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/30
|
3.1%
1/32
|
3.7%
1/27
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place