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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Global Alliance for TB Drug Development
ClinicalTrials.gov Identifier:
NCT01498419
First received: December 21, 2011
Last updated: March 15, 2017
Last verified: January 2017
Results First Received: July 12, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) 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: M (400 mg) Pa (200 mg) Z (1500 mg) 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: Rifafour 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: M (400 mg) Pa (200 mg) Z (1500 mg) 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

Participant Flow:   Overall Study
    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)
STARTED   60   62   59   26 
COMPLETED   42   39   41   7 
NOT COMPLETED   18   23   18   19 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) 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: M (400 mg) Pa (200 mg) Z (1500 mg) 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: Rifafour 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: M (400 mg) Pa (200 mg) Z (1500 mg) 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 Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 60   62   59   26   207 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 29.5  (10.63)   30.9  (8.96)   30.4  (9.75)   32.4  (9.75)   30.6  (9.77) 
[1] Safety Analysis Population
Sex: Female, Male [1] 
[Units: Participants]
Count of 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] Safety Analysis Population
Race/Ethnicity, Customized [1] 
[Units: Participants]
         
Black   43   46   43   15   147 
Mixed Ethnic   17   16   16   11   60 
[1] Safety Analysis Population
Weight [1] 
[Units: Kilograms]
Mean (Standard Deviation)
 54.7  (8.72)   57.6  (10.09)   54.7  (7.95)   57.9  (10.61)   56  (9.25) 
[1] Safety Analysis Population
HIV Status [1] 
[Units: 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] Safety Analysis Population
Pyrazinamide susceptibility [1] 
[Units: Participants]
         
Resistant   0   2   1   17   20 
Sensitive   60   59   58   9   186 
Missing   0   1   0   0   1 
[1] Safety Analysis Population
Moxifloxacin susceptibility [1] 
[Units: 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] Safety Analysis Population


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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.   [ Time Frame: 8 weeks ]

2.  Secondary:   Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Liquid Media   [ Time Frame: 8 weeks ]

3.  Secondary:   Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Solid Media   [ Time Frame: Day 57 after eight weeks of daily treatment ]

4.  Secondary:   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.   [ Time Frame: 8 weeks ]

5.  Secondary:   Percentage of Participants Who Discontinue Due to an Adverse Event in Each Experimental Arm.   [ Time Frame: 8 weeks ]

6.  Secondary:   Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Solid Media   [ Time Frame: 8 weeks ]

7.  Secondary:   Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Liquid Media   [ Time Frame: Day 57 after eight weeks of daily treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
e-mail: Dan.Everitt@tballiance.org


Publications of Results:

Responsible Party: Global Alliance for TB Drug Development
ClinicalTrials.gov Identifier: NCT01498419     History of Changes
Other Study ID Numbers: NC-002-(M-Pa-Z)
Study First Received: December 21, 2011
Results First Received: July 12, 2016
Last Updated: March 15, 2017