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Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002)

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ClinicalTrials.gov Identifier: NCT01498419
Recruitment Status : Completed
First Posted : December 23, 2011
Results First Posted : December 12, 2016
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Global Alliance for TB Drug Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Tuberculosis
Interventions Drug: Moxifloxacin (M)
Drug: Pretomid (Pa)
Drug: Pyrazinamide (Z)
Drug: Rifafour
Enrollment 207
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) Drug Sensitive: Rifafour Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)
Hide Arm/Group Description Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Period Title: Overall Study
Started 60 62 59 26
Completed 42 39 41 7
Not Completed 18 23 18 19
Arm/Group Title Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) Drug Sensitive: Rifafour Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg) Total
Hide Arm/Group Description Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 60 62 59 26 207
Hide Baseline Analysis Population Description
The ages of four participants in the Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) group and one participant in the Drug Sensitive: Rifafour group were missing and so were not included in the demographics.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 62 participants 59 participants 26 participants 207 participants
29.5  (10.63) 30.9  (8.96) 30.4  (9.75) 32.4  (9.75) 30.6  (9.77)
[1]
Measure Description: Safety Analysis Population
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 62 participants 59 participants 26 participants 207 participants
Female
22
  36.7%
22
  35.5%
18
  30.5%
10
  38.5%
72
  34.8%
Male
38
  63.3%
40
  64.5%
41
  69.5%
16
  61.5%
135
  65.2%
[1]
Measure Description: Safety Analysis Population
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 62 participants 59 participants 26 participants 207 participants
Black 43 46 43 15 147
Mixed Ethnic 17 16 16 11 60
[1]
Measure Description: Safety Analysis Population
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 60 participants 62 participants 59 participants 26 participants 207 participants
54.7  (8.72) 57.6  (10.09) 54.7  (7.95) 57.9  (10.61) 56  (9.25)
[1]
Measure Description: Safety Analysis Population
HIV Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 62 participants 59 participants 26 participants 207 participants
Positive 12 8 13 7 40
Negative 48 53 45 18 164
Indeterminate 0 0 1 0 1
Missing 0 1 0 1 2
[1]
Measure Description: Safety Analysis Population
Pyrazinamide susceptibility   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 62 participants 59 participants 26 participants 207 participants
Resistant 0 2 1 17 20
Sensitive 60 59 58 9 186
Missing 0 1 0 0 1
[1]
Measure Description: Safety Analysis Population
Moxifloxacin susceptibility   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 62 participants 59 participants 26 participants 207 participants
Resistant 0 2 1 1 4
Sensitive 56 58 57 25 196
No Result 3 2 1 0 6
Unclear 1 0 0 0 1
[1]
Measure Description: Safety Analysis Population
1.Primary Outcome
Title The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment.
Hide Description The primary efficacy endpoint was bactericidal activity characterized by the daily rate of change in mean log10CFU counts during 8 weeks of treatment (bactericidal activity assessed by CFU on solid media for days 0–56).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 173.
Arm/Group Title Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) Drug Sensitive: Rifafour Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)
Hide Arm/Group Description:
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Overall Number of Participants Analyzed 56 54 54 9
Mean (95% Confidence Interval)
Unit of Measure: log10CFU/ml/day
0.133
(0.109 to 0.155)
0.155
(0.133 to 0.178)
0.112
(0.093 to 0.131)
0.117
(0.070 to 0.174)
2.Secondary Outcome
Title Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Liquid Media
Hide Description liquid culture = Mycobacteria growth indicator tube (MGIT) Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants included for this outcome was 206.
Arm/Group Title Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) Drug Sensitive: Rifafour Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)
Hide Arm/Group Description:
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Overall Number of Participants Analyzed 60 61 59 26
Median (Inter-Quartile Range)
Unit of Measure: days
42.0 [1] 
(35.0 to NA)
49.0
(41.0 to 56.0)
56.0 [1] 
(43.0 to NA)
56.0 [1] 
(45.0 to NA)
[1]
There were not enough conversion events to determine the 75th percentile
3.Secondary Outcome
Title Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Solid Media
Hide Description Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB. (Day 57)
Time Frame Day 57 after eight weeks of daily treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. Participants included in this outcome had a valid, non-contaminated culture from the sample acquired on Day 57.
Arm/Group Title Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) Drug Sensitive: Rifafour Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)
Hide Arm/Group Description:
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Overall Number of Participants Analyzed 35 35 32 8
Measure Type: Number
Unit of Measure: percentage of participants
82.9 94.3 87.5 62.5
4.Secondary Outcome
Title The Rate of Change in Time to Sputum Culture Positivity (TTP) Through 8 Weeks in the MGIT System in Sputum Over 8 Weeks in Participants as Derived From a Non-linear Regression Model.
Hide Description Measurement of TTP in liquid culture media Mycobacteria growth indicator tube (MGIT) using standard procedures
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 179.
Arm/Group Title Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) Drug Sensitive: Rifafour Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)
Hide Arm/Group Description:
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Overall Number of Participants Analyzed 55 57 58 9
Mean (95% Confidence Interval)
Unit of Measure: log10hours/day
0.020
(0.015 to 0.025)
0.020
(0.016 to 0.024)
0.017
(0.013 to 0.021)
0.015
(-0.001 to 0.031)
5.Secondary Outcome
Title Percentage of Participants Who Discontinue Due to an Adverse Event in Each Experimental Arm.
Hide Description [Not Specified]
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population was analyzed for this outcome.
Arm/Group Title Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) Drug Sensitive: Rifafour Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)
Hide Arm/Group Description:
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Overall Number of Participants Analyzed 60 62 59 26
Measure Type: Number
Unit of Measure: percentage of participants
13 19 12 12
6.Secondary Outcome
Title Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Solid Media
Hide Description Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 206.
Arm/Group Title Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) Drug Sensitive: Rifafour Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)
Hide Arm/Group Description:
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Overall Number of Participants Analyzed 60 61 59 26
Median (Inter-Quartile Range)
Unit of Measure: days
28.0
(14.0 to 35.0)
28.0
(21.0 to 35.0)
35.0
(21.0 to 49.0)
35.0
(24.5 to 56.0)
7.Secondary Outcome
Title Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Liquid Media
Hide Description Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB. This was measured at visit 24(Day 57).
Time Frame Day 57 after eight weeks of daily treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. Participants included in this outcome had a valid, non-contaminated culture from the sample acquired on Day 57.
Arm/Group Title Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) Drug Sensitive: Rifafour Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)
Hide Arm/Group Description:
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
Overall Number of Participants Analyzed 35 35 37 8
Measure Type: Number
Unit of Measure: percentage of patients
65.7 71.4 37.8 50.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) Drug Sensitive: Rifafour Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)
Hide Arm/Group Description Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
All-Cause Mortality
Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) Drug Sensitive: Rifafour Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) Drug Sensitive: Rifafour Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/60 (1.67%)   7/62 (11.29%)   1/59 (1.69%)   0/26 (0.00%) 
Blood and lymphatic system disorders         
Agranulocytosis  0/60 (0.00%)  1/62 (1.61%)  0/59 (0.00%)  0/26 (0.00%) 
Cardiac disorders         
Cardiac Arrhythmia (2nd degree AV block)  0/60 (0.00%)  1/62 (1.61%)  0/59 (0.00%)  0/26 (0.00%) 
Congenital, familial and genetic disorders         
Epileptic Seizures  0/60 (0.00%)  1/62 (1.61%)  0/59 (0.00%)  0/26 (0.00%) 
General disorders         
Death - Cause Unknown  1/60 (1.67%)  0/62 (0.00%)  0/59 (0.00%)  0/26 (0.00%) 
Hepatobiliary disorders         
Drug-Induced Hepatitis  0/60 (0.00%)  1/62 (1.61%)  0/59 (0.00%)  0/26 (0.00%) 
Elevated Liver Enzymes  0/60 (0.00%)  1/62 (1.61%)  0/59 (0.00%)  0/26 (0.00%) 
Liver Drug-Induced Toxicity  0/60 (0.00%)  0/62 (0.00%)  1/59 (1.69%)  0/26 (0.00%) 
Metabolism and nutrition disorders         
Hyperuriceamia  0/60 (0.00%)  1/62 (1.61%)  0/59 (0.00%)  0/26 (0.00%) 
Musculoskeletal and connective tissue disorders         
Closed Tibia Plateau Fracture-Left Knee Joint  0/60 (0.00%)  1/62 (1.61%)  0/59 (0.00%)  0/26 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumothorax  0/60 (0.00%)  1/62 (1.61%)  0/59 (0.00%)  0/26 (0.00%) 
Dyspnoea  0/60 (0.00%)  1/62 (1.61%)  0/59 (0.00%)  0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) Drug Sensitive: Rifafour Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   52/60 (86.67%)   57/62 (91.94%)   50/59 (84.75%)   23/26 (88.46%) 
Blood and lymphatic system disorders         
LEUKOCYTOSIS  5/60 (8.33%)  4/62 (6.45%)  3/59 (5.08%)  0/26 (0.00%) 
Gastrointestinal disorders         
NAUSEA  14/60 (23.33%)  8/62 (12.90%)  7/59 (11.86%)  8/26 (30.77%) 
VOMITING  7/60 (11.67%)  7/62 (11.29%)  7/59 (11.86%)  4/26 (15.38%) 
DIARRHOEA  4/60 (6.67%)  3/62 (4.84%)  3/59 (5.08%)  3/26 (11.54%) 
ABDOMINAL PAIN  6/60 (10.00%)  2/62 (3.23%)  3/59 (5.08%)  1/26 (3.85%) 
Hepatobiliary disorders         
LIVER DISORDER  16/60 (26.67%)  14/62 (22.58%)  9/59 (15.25%)  3/26 (11.54%) 
Metabolism and nutrition disorders         
HYPERURICAEMIA  17/60 (28.33%)  17/62 (27.42%)  17/59 (28.81%)  8/26 (30.77%) 
HYPONATRAEMIA  8/60 (13.33%)  5/62 (8.06%)  8/59 (13.56%)  0/26 (0.00%) 
HYPERGLYCAEMIA  4/60 (6.67%)  2/62 (3.23%)  3/59 (5.08%)  3/26 (11.54%) 
ENZYME ABNORMALITY  2/60 (3.33%)  4/62 (6.45%)  4/59 (6.78%)  1/26 (3.85%) 
HYPOALBUMINAEMIA  4/60 (6.67%)  2/62 (3.23%)  5/59 (8.47%)  0/26 (0.00%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  20/60 (33.33%)  18/62 (29.03%)  11/59 (18.64%)  0/26 (0.00%) 
Nervous system disorders         
DIZZINESS  6/60 (10.00%)  8/62 (12.90%)  2/59 (3.39%)  1/26 (3.85%) 
HEADACHE  6/60 (10.00%)  6/62 (9.68%)  2/59 (3.39%)  2/26 (7.69%) 
Skin and subcutaneous tissue disorders         
PRURITUS  5/60 (8.33%)  2/62 (3.23%)  5/59 (8.47%)  1/26 (3.85%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator or any Sub-Investigator shall submit any oral or written publication or abstract concerning this study to the Sponsor not less than thirty (30) days prior to submission to any journal, other publication or meeting, for review and removal of confidential information.
Results Point of Contact
Name/Title: Daniel E. Everitt, MD, Vice President and Senior Medical Officer
Organization: Global Alliance for TB Drug Development
Phone: (212) 227-7540
Responsible Party: Global Alliance for TB Drug Development
ClinicalTrials.gov Identifier: NCT01498419     History of Changes
Other Study ID Numbers: NC-002-(M-Pa-Z)
First Submitted: December 21, 2011
First Posted: December 23, 2011
Results First Submitted: July 12, 2016
Results First Posted: December 12, 2016
Last Update Posted: June 28, 2018