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Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00944021
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : March 9, 2016
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Global Alliance for TB Drug Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pulmonary Tuberculosis
Interventions Drug: PA-824
Drug: Rifafour e-275 mg
Enrollment 69
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd Rifafour e-275mg
Hide Arm/Group Description PA-824 : 50mg oral tablet PA-824 : 100mg oral tablet PA-824 : 150 mg oral tablet PA-824 : 200 mg oral tablet Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
Period Title: Overall Study
Started 15 15 15 16 8
Completed 14 15 15 16 8
Not Completed 1 0 0 0 0
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd Rifafour e-275mg Total
Hide Arm/Group Description PA-824 : 50mg oral tablet PA-824 : 100mg oral tablet PA-824 : 150 mg oral tablet PA-824 : 200 mg oral tablet Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets). Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 16 8 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 16 participants 8 participants 69 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
15
 100.0%
15
 100.0%
16
 100.0%
8
 100.0%
69
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 15 participants 16 participants 8 participants 69 participants
30.5  (9.76) 29.6  (9.28) 26.9  (8.91) 25.3  (6.18) 33.3  (14.09) 28.6  (9.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 16 participants 8 participants 69 participants
Female
8
  53.3%
7
  46.7%
8
  53.3%
9
  56.3%
2
  25.0%
34
  49.3%
Male
7
  46.7%
8
  53.3%
7
  46.7%
7
  43.8%
6
  75.0%
35
  50.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Africa Number Analyzed 15 participants 15 participants 15 participants 16 participants 8 participants 69 participants
15 15 15 16 8 69
1.Primary Outcome
Title Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).
Hide Description [Not Specified]
Time Frame 14 consecutive days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd Rifafour e-275mg
Hide Arm/Group Description:
PA-824 : 50mg oral tablet
PA-824 : 100mg oral tablet
PA-824 : 150 mg oral tablet
PA-824 : 200 mg oral tablet
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
Overall Number of Participants Analyzed 12 15 14 14 8
Mean (Standard Deviation)
Unit of Measure: log10CFU/ml/day
0.063  (0.058) 0.091  (0.073) 0.078  (0.074) 0.112  (0.070) 0.177  (0.042)
2.Secondary Outcome
Title Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).
Hide Description [Not Specified]
Time Frame Two consecutive days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd Rifafour e-275mg
Hide Arm/Group Description:
PA-824 : 50mg oral tablet
PA-824 : 100mg oral tablet
PA-824 : 150 mg oral tablet
PA-824 : 200 mg oral tablet
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
Overall Number of Participants Analyzed 14 15 15 14 8
Mean (Standard Deviation)
Unit of Measure: log10CFU/ml/day
0.093  (0.211) 0.111  (0.332) -0.009  (0.290) 0.160  (0.255) 0.470  (0.316)
3.Secondary Outcome
Title Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).
Hide Description [Not Specified]
Time Frame Days 2-14 of 14 consecutive days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd Rifafour e-275mg
Hide Arm/Group Description:
PA-824 : 50mg oral tablet
PA-824 : 100mg oral tablet
PA-824 : 150 mg oral tablet
PA-824 : 200 mg oral tablet
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
Overall Number of Participants Analyzed 12 15 14 14 8
Mean (Standard Deviation)
Unit of Measure: log10CFU/ml/day
0.059  (0.060) 0.088  (0.085) 0.096  (0.98) 0.104  (0.083) 0.128  (0.070)
4.Secondary Outcome
Title Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14).
Hide Description [Not Specified]
Time Frame Fourteen consecutive days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd Rifafour e-275mg
Hide Arm/Group Description:
PA-824 : 50mg oral tablet
PA-824 : 100mg oral tablet
PA-824 : 150 mg oral tablet
PA-824 : 200 mg oral tablet
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
Overall Number of Participants Analyzed 13 14 15 16 8
Mean (Standard Deviation)
Unit of Measure: hours/day
2.621  (2.534) 4.969  (3.644) 4.633  (3.687) 4.640  (3.447) 13.364  (3.979)
5.Secondary Outcome
Title Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2).
Hide Description [Not Specified]
Time Frame Two consecutive days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd Rifafour e-275mg
Hide Arm/Group Description:
PA-824 : 50mg oral tablet
PA-824 : 100mg oral tablet
PA-824 : 150 mg oral tablet
PA-824 : 200 mg oral tablet
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
Overall Number of Participants Analyzed 15 14 15 13 8
Mean (Standard Deviation)
Unit of Measure: hours/day
1.483  (8.153) -1.345  (8.586) 4.867  (12.755) 3.096  (8.202) 37.016  (5.639)
6.Secondary Outcome
Title Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14).
Hide Description [Not Specified]
Time Frame Days 2-14 of 14 consecutive days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd Rifafour e-275mg
Hide Arm/Group Description:
PA-824 : 50mg oral tablet
PA-824 : 100mg oral tablet
PA-824 : 150 mg oral tablet
PA-824 : 200 mg oral tablet
Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
Overall Number of Participants Analyzed 13 15 15 13 8
Mean (Standard Deviation)
Unit of Measure: hours/day
2.958  (2.652) 5.744  (3.973) 4.594  (5.035) 5.391  (3.608) 9.422  (4.367)
7.Secondary Outcome
Title Pharmacokinetics- Maximum Observed Plasma Concentration (Cmax) (Day 1).
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd
Hide Arm/Group Description:
PA-824 : 50mg oral tablet
PA-824 : 100mg oral tablet
PA-824 : 150 mg oral tablet
PA-824 : 200 mg oral tablet
Overall Number of Participants Analyzed 15 15 15 16
Mean (Standard Deviation)
Unit of Measure: ng/mL
465.3  (150.6) 662.3  (167.8) 994.7  (305.7) 1183.0  (382.5)
8.Secondary Outcome
Title Pharmacokinetics- Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC 0 to Infinity) (Day 1).
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd
Hide Arm/Group Description:
PA-824 : 50mg oral tablet
PA-824 : 100mg oral tablet
PA-824 : 150 mg oral tablet
PA-824 : 200 mg oral tablet
Overall Number of Participants Analyzed 15 15 15 16
Mean (Standard Deviation)
Unit of Measure: ng * hour/mL
11923.94  (4512.94) 18408.59  (7665.35) 28654.83  (10924.23) 38485.04  (16606.96)
9.Secondary Outcome
Title Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 1).
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd
Hide Arm/Group Description:
PA-824 : 50mg oral tablet
PA-824 : 100mg oral tablet
PA-824 : 150 mg oral tablet
PA-824 : 200 mg oral tablet
Overall Number of Participants Analyzed 15 15 15 16
Mean (Standard Deviation)
Unit of Measure: hours
16.142  (5.501) 18.597  (9.459) 19.005  (7.349) 21.092  (6.490)
10.Secondary Outcome
Title Pharmacokinetics-Maximum Observed Plasma Concentration (Cmax) (Day 14).
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12,16, 24, and 30 hours post-dose on Day 14 of 14 consecutive days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd
Hide Arm/Group Description:
PA-824 : 50mg oral tablet
PA-824 : 100mg oral tablet
PA-824 : 150 mg oral tablet
PA-824 : 200 mg oral tablet
Overall Number of Participants Analyzed 15 15 15 16
Mean (Standard Deviation)
Unit of Measure: ng/mL
777.3  (250.7) 1116.5  (357.4) 1543.9  (511.4) 2223.8  (734.5)
11.Secondary Outcome
Title Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 14).
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24 and 30 hours post-dose on Day 14 of 14 consecutive days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd
Hide Arm/Group Description:
PA-824 : 50mg oral tablet
PA-824 : 100mg oral tablet
PA-824 : 150 mg oral tablet
PA-824 : 200 mg oral tablet
Overall Number of Participants Analyzed 15 15 15 16
Mean (Standard Deviation)
Unit of Measure: hour
18.645  (5.394) 19.274  (10.249) 20.207  (5.288) 23.811  (8.067)
Time Frame 180 days
Adverse Event Reporting Description Adverse events were collected from the time a patient signed the informed consent until day 29. From day 29 through day 180, only opthalmologic related adverse events and serious adverse events were collected. Data reported are treatment-emergent adverse events.
 
Arm/Group Title PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd Rifafour e-275mg
Hide Arm/Group Description PA-824 : 50mg oral tablet PA-824 : 100mg oral tablet PA-824 : 150 mg oral tablet PA-824 : 200 mg oral tablet Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
All-Cause Mortality
PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd Rifafour e-275mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd Rifafour e-275mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      0/15 (0.00%)      0/15 (0.00%)      1/16 (6.25%)      0/8 (0.00%)    
Infections and infestations           
Pneumonia  0/15 (0.00%)  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Pneumothorax  1/15 (6.67%)  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/8 (0.00%)  0
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
PA-824 50 mg/qd PA-824 100mg/qd PA-824 150mg/qd PA-824 200mg/qd Rifafour e-275mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/15 (66.67%)      5/15 (33.33%)      5/15 (33.33%)      7/16 (43.75%)      4/8 (50.00%)    
Cardiac disorders           
Bundle branch block left  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Tachycardia  1/15 (6.67%)  1/15 (6.67%)  0/15 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Eye disorders           
Lenticular opacities  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  1/8 (12.50%) 
Ocular hyperaemia  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/8 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Abdominal pain upper  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Diarrhoea  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Gingivitis  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/8 (0.00%) 
Nausea  1/15 (6.67%)  0/15 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  1/8 (12.50%) 
Vomiting  1/15 (6.67%)  0/15 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  1/8 (12.50%) 
General disorders           
Chills  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Fatigue  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Pyrexia  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Infections and infestations           
Vaginal infection  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Investigations           
Haemoglobin decreased  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Heart rate increased  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Hepatic enzyme increased  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Metabolism and nutrition disorders           
Hyponatraemia  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Nervous system disorders           
Dizziness  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Headache  2/15 (13.33%)  0/15 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Neuropathy peripheral  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Psychiatric disorders           
Euphoric mood  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Haemoptysis  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/8 (0.00%) 
Pleuritic pain  0/15 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  1/8 (12.50%) 
Skin and subcutaneous tissue disorders           
Pruritis  1/15 (6.67%)  1/15 (6.67%)  0/15 (0.00%)  0/16 (0.00%)  1/8 (12.50%) 
Pruritus generalised  1/15 (6.67%)  1/15 (6.67%)  0/15 (0.00%)  1/16 (6.25%)  0/8 (0.00%) 
Rash  1/15 (6.67%)  0/15 (0.00%)  1/15 (6.67%)  0/16 (0.00%)  0/8 (0.00%) 
Rash macular  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  0/8 (0.00%) 
Rash papular  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%)  3/16 (18.75%)  0/8 (0.00%) 
Urticaria  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%)  0/16 (0.00%)  1/8 (12.50%) 
1
Term from vocabulary, MedDRA (12.0)
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.
 
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: NCT00944021     History of Changes
Other Study ID Numbers: PA-824-CL-010
First Submitted: July 21, 2009
First Posted: July 22, 2009
Results First Submitted: February 19, 2014
Results First Posted: March 9, 2016
Last Update Posted: April 12, 2017