Trial Outcomes & Findings for Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis (NCT NCT00396084)
NCT ID: NCT00396084
Last Updated: 2018-11-08
Results Overview
The adjusted area under the curve (aAUC) for sputum colony forming units (cfu) for each day on treatment was calculated. The aAUC represents the percentage of the expected AUC given no change in log cfu in response to study drug administration.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Study drug administration duration - 7 days monotherapy
Results posted on
2018-11-08
Participant Flow
Screening for the trial began in February 2004 in Vitória, Brazil. Non-HIV infected adults aged 18-65 years with suspected pulmonary tuberculosis (TB) were recruited at local TB posts and the Hospital Universitario Cassiano Antonio de Moraes of the Universidade Federal do Espírito Santo (UFES) in Vitória. Enrollment was completed in October 2007.
A total of 113 adults with suspected pulmonary TB were evaluated for study participation. Forty-three were excluded because they did not meet the eligibility criteria, leaving a total of 70 patients.
Participant milestones
| Measure |
Gatifloxacin 400 mg/Day
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
Levofloxacin 1000 mg/day x 7days
|
Linezolid 600 mg / Once Daily
Linezolid 600 mg/once daily x 7days
|
Linezolid 600 mg / Twice Daily
Linezolid 600 mg twice daily x 7 days
|
Moxifloxacin 400 mg/Day
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
20
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
9
|
9
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Gatifloxacin 400 mg/Day
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
Levofloxacin 1000 mg/day x 7days
|
Linezolid 600 mg / Once Daily
Linezolid 600 mg/once daily x 7days
|
Linezolid 600 mg / Twice Daily
Linezolid 600 mg twice daily x 7 days
|
Moxifloxacin 400 mg/Day
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis
Baseline characteristics by cohort
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Linezolid 600 mg / Once Daily
n=10 Participants
Linezolid 600 mg/once daily x 7days
|
Linezolid 600 mg / Twice Daily
n=10 Participants
Linezolid 600 mg twice daily x 7 days
|
Moxifloxacin 400 mg/Day
n=10 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
n=20 Participants
Isoniazid (INH) 300 mg/day x 7 days
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
70 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
34.5 years
INTER_QUARTILE_RANGE 10.1 • n=5 Participants
|
43.5 years
INTER_QUARTILE_RANGE 6.4 • n=7 Participants
|
33.5 years
INTER_QUARTILE_RANGE 13.4 • n=5 Participants
|
45.0 years
INTER_QUARTILE_RANGE 12.7 • n=4 Participants
|
35.0 years
INTER_QUARTILE_RANGE 8.4 • n=21 Participants
|
33.0 years
INTER_QUARTILE_RANGE 11.4 • n=8 Participants
|
35.0 years
INTER_QUARTILE_RANGE 11.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
59 Participants
n=8 Participants
|
|
Region of Enrollment
Brazil
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
10 participants
n=21 Participants
|
20 participants
n=8 Participants
|
70 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Study drug administration duration - 7 days monotherapyPopulation: The aAUC was calculated for 10 subjects per treatment arm (n=40).
The adjusted area under the curve (aAUC) for sputum colony forming units (cfu) for each day on treatment was calculated. The aAUC represents the percentage of the expected AUC given no change in log cfu in response to study drug administration.
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=10 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
n=10 Participants
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 1
|
0.98 Percentage
Standard Deviation 0.03
|
0.98 Percentage
Standard Deviation 0.03
|
0.96 Percentage
Standard Deviation 0.04
|
0.95 Percentage
Standard Deviation 0.03
|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 2
|
0.96 Percentage
Standard Deviation 0.03
|
0.95 Percentage
Standard Deviation 0.05
|
0.94 Percentage
Standard Deviation 0.06
|
0.90 Percentage
Standard Deviation 0.04
|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 3
|
0.92 Percentage
Standard Deviation 0.05
|
0.91 Percentage
Standard Deviation 0.07
|
0.91 Percentage
Standard Deviation 0.08
|
0.87 Percentage
Standard Deviation 0.04
|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 4
|
0.89 Percentage
Standard Deviation 0.07
|
0.88 Percentage
Standard Deviation 0.08
|
0.89 Percentage
Standard Deviation 0.09
|
0.84 Percentage
Standard Deviation 0.04
|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 5
|
0.87 Percentage
Standard Deviation 0.08
|
0.85 Percentage
Standard Deviation 0.09
|
0.87 Percentage
Standard Deviation 0.10
|
0.81 Percentage
Standard Deviation 0.05
|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 6
|
0.85 Percentage
Standard Deviation 0.08
|
0.83 Percentage
Standard Deviation 0.10
|
0.85 Percentage
Standard Deviation 0.10
|
0.80 Percentage
Standard Deviation 0.06
|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 7
|
0.82 Percentage
Standard Deviation 0.09
|
0.81 Percentage
Standard Deviation 0.10
|
0.83 Percentage
Standard Deviation 0.10
|
0.80 Percentage
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: Day 0 to Day 2 MonotherapyPopulation: Early bactericidal activity (EBA 0-2) was calculated for 10 subjects per treatment arm (n=40).
Early bactericidal activity (EBA 0-2) was calculated as the rate of fall in sputum colony forming units (cfu) (expressed in log10 units) during the first 2 days of monotherapy.
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=10 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
n=10 Participants
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Fluoroquinolones/Isoniazid (INH) Comparison
|
0.35 log10 cfu/ml/day
Standard Deviation 0.27
|
0.45 log10 cfu/ml/day
Standard Deviation 0.35
|
0.33 log10 cfu/ml/day
Standard Deviation 0.39
|
0.67 log10 cfu/ml/day
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: Day 2 to Day 7 MonotherapyPopulation: A total of 38 patients were analyzed for Early Bactericidal Activity (EBA) Days 2-7. One patient in the moxifloxacin arm discontinued the study drug after 4 days. One patient in the INH arm discontinued the study drug after 6 days.
The rate of fall in sputum cfu between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained by fitting the 6 sputum cfu values corresponding to Days 2 through 7.
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
n=9 Participants
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Extended Early Bactericidal Activity (EBA) From Days 2 to 7; Fluoroquinolones/Isoniazid (INH) Comparison
|
0.17 log10 cfu/ml/day
Standard Deviation 0.13
|
0.18 log10 cfu/ml/day
Standard Deviation 0.13
|
0.17 log10 cfu/ml/day
Standard Deviation 0.09
|
0.08 log10 cfu/ml/day
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: Study drug administration duration - 7 days monotherapyPopulation: The aAUC was calculated for 29 patients. One patient in the linezolid twice daily arm withdrew after randomization before receiving any doses of study drug.
The adjusted area under the curve (aAUC) for sputum colony forming unit (cfu) for each day on treatment was calculated for patients in the INH arm and those in the Linezolid once daily and Linezolid twice daily arms. The aAUC represents the percentage of the expected AUC given no change in log cfu in response to study drug administration.
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 1
|
0.94 Percentage
Standard Deviation 0.06
|
0.98 Percentage
Standard Deviation 0.04
|
0.98 Percentage
Standard Deviation 0.04
|
—
|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 2
|
0.89 Percentage
Standard Deviation 0.08
|
0.97 Percentage
Standard Deviation 0.07
|
0.96 Percentage
Standard Deviation 0.07
|
—
|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 3
|
0.89 Percentage
Standard Deviation 0.03
|
0.96 Percentage
Standard Deviation 0.07
|
0.95 Percentage
Standard Deviation 0.08
|
—
|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 4
|
0.85 Percentage
Standard Deviation 0.09
|
0.96 Percentage
Standard Deviation 0.07
|
0.94 Percentage
Standard Deviation 0.08
|
—
|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 5
|
0.83 Percentage
Standard Deviation 0.10
|
0.95 Percentage
Standard Deviation 0.07
|
0.94 Percentage
Standard Deviation 0.08
|
—
|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 6
|
0.81 Percentage
Standard Deviation 0.12
|
0.95 Percentage
Standard Deviation 0.07
|
0.93 Percentage
Standard Deviation 0.07
|
—
|
|
Sputum Bacillary Loads: Adjusted Area Under the Curve (aAUC)
Day 7
|
0.83 Percentage
Standard Deviation 0.07
|
0.95 Percentage
Standard Deviation 0.07
|
0.93 Percentage
Standard Deviation 0.07
|
—
|
PRIMARY outcome
Timeframe: Day 0 to Day 2 MonotherapyPopulation: EBA 0-2 comparisons across groups were done for 29 patients. One patient in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.
Early bactericidal activity (EBA 0-2) was calculated as the rate of fall in sputum cfu (expressed in log10 units) during the first 2 days of monotherapy. Mean values for the 3 treatment groups were compared.
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Difference in Sputum Bacillary Loads: Early Bactericidal Activity (EBA) Days 0 to 2; Linezolid Once Daily/Linezolid Twice Daily/Isoniazid (INH) Comparison
|
0.67 log10 cfu/ml/day
Standard Deviation 0.35
|
0.18 log10 cfu/ml/day
Standard Deviation 0.27
|
0.26 log10 cfu/ml/day
Standard Deviation 0.42
|
—
|
PRIMARY outcome
Timeframe: Day 2 to Day 7 MonotherapyPopulation: One patient in the INH arm discontinued the study drug after 5 days. Days 3 and 7 cultures for another patient in the INH arm were contaminated and cfu data are not available for this patient. One patient in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.
The rate of fall in sputum cfu between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained by fitting the 6 sputum cfu values corresponding to Days 2 through 7.
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=8 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Difference in Sputum Bacillary Loads: Extended Early Bactericidal Activity (EBA) From Days 2 to 7; Linezolid Once Daily/Linezolid Twice Daily/INH Comparison
|
0.16 log10 cfu/ml
Standard Deviation 0.11
|
0.09 log10 cfu/ml
Standard Deviation 0.17
|
0.04 log10 cfu/ml
Standard Deviation 0.11
|
—
|
SECONDARY outcome
Timeframe: Study drug administration durationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study drug administration durationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 5 (7 time points)Population: Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. Plasma samples were collected at 7 time points on the 5th day after beginning study drug monotherapy. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.
Maximum plasma concentration, given sampling scheme
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
n=10 Participants
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Maximum Plasma Drug Concentration (Cmax)
|
4.8 ug/ml
Interval 3.8 to 6.4
|
15.6 ug/ml
Interval 8.6 to 43.0
|
6.1 ug/ml
Interval 4.5 to 9.0
|
3.6 ug/ml
Interval 2.5 to 6.1
|
SECONDARY outcome
Timeframe: Day 5 (7 time points)Population: Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
n=10 Participants
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Time to Maximum Plasma Drug Concentration (Tmax) and Half-life
Tmax
|
1.5 hours
Interval 1.0 to 8.0
|
1.0 hours
Interval 1.0 to 4.0
|
1.0 hours
Interval 1.0 to 2.0
|
1 hours
Interval 1.0 to 2.0
|
|
Time to Maximum Plasma Drug Concentration (Tmax) and Half-life
Half-life
|
6.0 hours
Interval 5.2 to 9.3
|
7.6 hours
Interval 4.4 to 19.1
|
8.1 hours
Interval 5.1 to 9.9
|
2.5 hours
Interval 1.5 to 4.9
|
SECONDARY outcome
Timeframe: Day 5 (7 time points)Population: Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
n=10 Participants
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Maximum Plasma Drug Concentration/Minimum Inhibitory Concentration (Cmax/MIC)
|
9.5 ug/ml
Interval 8.4 to 11.3
|
15.6 ug/ml
Interval 12.2 to 16.6
|
12.3 ug/ml
Interval 9.6 to 13.4
|
70.6 ug/ml
Interval 64.0 to 76.2
|
SECONDARY outcome
Timeframe: Day 5 (7 time points)Population: Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. Plasma samples were collected at 7 time points on the 5th day after beginning study drug monotherapy. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling.
Area under the curve (AUC), from time 0-12 hours for INH or 0-24 hours for gatifloxacin, levofloxacin, and moxifloxacin.
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
n=10 Participants
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters: Area Under the Curve (AUC) During First 12 and 24 Hours
|
42.8 ug/h/ml
Interval 31.7 to 51.0
|
129.1 ug/h/ml
Interval 103.4 to 358.3
|
55.3 ug/h/ml
Interval 36.0 to 79.1
|
11.9 ug/h/ml
Interval 7.1 to 37.4
|
SECONDARY outcome
Timeframe: Day 5 (7 time points)Population: Thirty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the moxifloxacin arm was discontinued from the study before day 5 and did not undergo PK sampling
Area Under the Curve (AUC) During First 12 or 24 Hours /Minimum Inhibitory Concentration. AUC reflects total drug (bound and unbound). MIC values were determined using protein-containing media.
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
n=10 Participants
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Area Under the Curve During First 12 or 24 Hours / Minimum Inhibitory Concentration (AUC/MIC)
|
85.6 ug/ml
Interval 70.7 to 89.7
|
129.1 ug/ml
Interval 121.0 to 145.0
|
110.5 ug/ml
Interval 98.9 to 121.6
|
215.2 ug/ml
Interval 177.4 to 329.6
|
SECONDARY outcome
Timeframe: Day 5 (7 time points)Population: Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.
Maximum Plasma Drug Concentration (Cmax), given sampling scheme
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Maximum Plasma Drug Concentration (Cmax)
|
3.3 ug/ml
Interval 2.5 to 5.3
|
15.0 ug/ml
Interval 11.9 to 21.3
|
19.4 ug/ml
Interval 11.8 to 24.9
|
—
|
SECONDARY outcome
Timeframe: Day 5 (7 time points)Population: Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Time to Maximum Plasma Drug Concentration (Tmax) and Half-life
Tmax in h (apparent time of max plasma conc.)
|
1.0 hours
Interval 1.0 to 2.0
|
1.5 hours
Interval 1.0 to 4.0
|
1.0 hours
Interval 1.0 to 4.0
|
—
|
|
Time to Maximum Plasma Drug Concentration (Tmax) and Half-life
Half-life
|
3.6 hours
Interval 1.1 to 4.5
|
3.20 hours
Interval 1.5 to 5.0
|
4.56 hours
Interval 2.1 to 7.0
|
—
|
SECONDARY outcome
Timeframe: Day 5 (7 time points)Population: Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.
Median pharmacokinetic parameters (range). AUC 0-12 and AUC 0-24 = area under the curve during the first 12 and 24 hours after dosing, respectively
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters: Area Under the Curve During First 12 and 24 Hours
AUC 0-12 (ug/h/ml)
|
17.0 ug/h/ml
Interval 6.5 to 26.9
|
87.0 ug/h/ml
Interval 47.5 to 119.3
|
116.4 ug/h/ml
Interval 50.4 to 197.2
|
—
|
|
Pharmacokinetic Parameters: Area Under the Curve During First 12 and 24 Hours
AUC 0-24 (ug/h/ml)
|
19.2 ug/h/ml
Interval 6.5 to 29.0
|
96.9 ug/h/ml
Interval 47.8 to 143.7
|
232.9 ug/h/ml
Interval 100.8 to 394.4
|
—
|
SECONDARY outcome
Timeframe: Day 5 (7 time points)Population: Twenty-nine patients underwent pharmacokinetic (PK) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.
Cmax adjusted for free drug concentrations after 5 days of monotherapy with study drugs
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Maximum Plasma Drug Concentrations (Cmax), Adjusted for Free Drug Concentration
|
3.1 ug/ml
Interval 2.5 to 4.8
|
10.3 ug/ml
Interval 8.2 to 14.7
|
13.4 ug/ml
Interval 8.1 to 17.2
|
—
|
SECONDARY outcome
Timeframe: Day 5 (7 time points)Population: Twenty-nine patients underwent pharmacodynamic sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Maximum Plasma Drug Concentration/Minimum Inhibitory Concentration (Cmax/MIC) Adjusted for Free Drug Concentrations
|
62.7 ug/ml
Interval 51.0 to 77.3
|
20.0 ug/ml
Interval 10.2 to 21.9
|
16.2 ug/ml
Interval 14.3 to 23.0
|
—
|
SECONDARY outcome
Timeframe: Day 5 (7 time points)Population: Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.
Median pharmacodynamic parameters (range) adjusted for free drug concentrations. AUC 0-12 and AUC 0-24 = area under the curve during the first 12 and 24 hours after dosing, respectively
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Area Under the Curve (AUC) During First 12 and 24 Hours Adjusted for Free Drug Concentrations
AUC 0-12
|
15.3 ug/h/ml
Interval 5.8 to 24.2
|
60.1 ug/h/ml
Interval 32.8 to 82.3
|
80.3 ug/h/ml
Interval 34.8 to 136.1
|
—
|
|
Area Under the Curve (AUC) During First 12 and 24 Hours Adjusted for Free Drug Concentrations
AUC 0-24
|
17.2 ug/h/ml
Interval 5.8 to 26.1
|
66.8 ug/h/ml
Interval 33.0 to 99.2
|
160.7 ug/h/ml
Interval 134.4 to 225.8
|
—
|
SECONDARY outcome
Timeframe: Day 5 (7 time points)Population: Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.
Area Under the Curve 0-12 (AUC 0-12) Adjusted for Free Drug Concentrations/Minimum Inhibitory Concentration (MIC) and AUC 0-24/MIC
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=9 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Area Under the Curve (AUC) Adjusted for Free Drug Concentrations/Minimum Inhibitory Concentration (MIC)
AUC 0-12/MIC
|
306.7 ug/h/ml
Interval 229.3 to 405.2
|
107.8 ug/h/ml
Interval 63.4 to 126.3
|
121.6 ug/h/ml
Interval 79.8 to 141.6
|
—
|
|
Area Under the Curve (AUC) Adjusted for Free Drug Concentrations/Minimum Inhibitory Concentration (MIC)
AUC 0-24/MIC
|
344.6 ug/h/ml
Interval 249.4 to 449.2
|
116.2 ug/h/ml
Interval 71.0 to 138.4
|
243.2 ug/h/ml
Interval 159.7 to 283.2
|
—
|
SECONDARY outcome
Timeframe: Day 5 (7 time points)Population: Twenty-nine patients underwent pharmacodynamic (PD) sampling after receiving 5 daily doses of study drug. One subject in the linezolid twice daily arm withdrew from the study after randomization before receiving any doses of study drug.
Determined by linear extrapolation of concentration-versus-time curve to intersection with MIC.
Outcome measures
| Measure |
Gatifloxacin 400 mg/Day
n=10 Participants
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 Participants
Levofloxacin 1000 mg/day x 7days
|
Moxifloxacin 400 mg/Day
n=10 Participants
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|
|
Percent Dosing Interval Above Minimum Inhibitory Concentration (MIC)
|
95.5 Percentage
Interval 76.4 to 100.0
|
62.8 Percentage
Interval 54.6 to 77.0
|
100.0 Percentage
Interval 100.0 to 100.0
|
—
|
Adverse Events
Gatifloxacin 400 mg/Day
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Levofloxacin 1000 mg/Day
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Linezolid 600 mg / Once Daily
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Linezolid 600 mg / Twice Daily
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Moxifloxacin 400 mg/Day
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Isoniazid (INH) 300 mg/Day
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gatifloxacin 400 mg/Day
n=10 participants at risk
Gatifloxacin 400 mg/day x 7 days
|
Levofloxacin 1000 mg/Day
n=10 participants at risk
Levofloxacin 1000 mg/day x 7days
|
Linezolid 600 mg / Once Daily
n=10 participants at risk
Linezolid 600 mg/once daily x 7days
|
Linezolid 600 mg / Twice Daily
n=10 participants at risk
Linezolid 600 mg twice daily x 7 days
|
Moxifloxacin 400 mg/Day
n=10 participants at risk
Moxifloxacin 400 mg/day x 7 days
|
Isoniazid (INH) 300 mg/Day
n=20 participants at risk
Isoniazid (INH) 300 mg/day x 7 days
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
30.0%
3/10 • Number of events 3 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/20 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
30.0%
3/10 • Number of events 3 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/20 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Blood and lymphatic system disorders
Elevated Monocytes
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/20 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
General disorders
Fever
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/20 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Blood and lymphatic system disorders
Hematocrit Decreased
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/20 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Blood and lymphatic system disorders
Hemoglobin Decreased
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
30.0%
3/10 • Number of events 3 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/20 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Gastrointestinal disorders
Intestinal Ancyclostomiasis
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Gastrointestinal disorders
Intestinal Constipation
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
10.0%
1/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/20 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Gastrointestinal disorders
Intestinal Strongyloidiasis
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Pain
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
10.0%
1/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/20 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Musculoskeletal and connective tissue disorders
Pain in Both Shoulders
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
10.0%
1/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/20 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Respiratory, thoracic and mediastinal disorders
Rales (or Crackles)
|
40.0%
4/10 • Number of events 5 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
40.0%
4/10 • Number of events 6 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
60.0%
6/10 • Number of events 13 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
35.0%
7/20 • Number of events 17 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Respiratory, thoracic and mediastinal disorders
Ronchi
|
20.0%
2/10 • Number of events 3 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
5.0%
1/20 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
General disorders
Sweating
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/20 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
0.00%
0/10 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected from February 2004 through October 2007.
Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site.
|
Additional Information
John L. Johnson, M.D.
Case Western Reserve University, Tuberculosis Research Unit
Phone: (216) 368-1949
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place