Shortening Treatment by Advancing Novel Drugs (STAND)
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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: NCT02342886 |
Recruitment Status :
Completed
First Posted : January 21, 2015
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
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Sponsor:
Global Alliance for TB Drug Development
Information provided by (Responsible Party):
Global Alliance for TB Drug Development
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Tuberculosis, Pulmonary, Drug Sensitive Tuberculosis, Pulmonary, Multi Drug-resistant |
Interventions |
Drug: Moxifloxacin Drug: PA-824 Drug: Pyrazinamide Drug: HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination) Drug: HR (rifampicin plus isoniazid combination tablets) |
Enrollment | 284 |
Participant Flow
Recruitment Details | Adult male and female patients with drug-sensitive (DS) and multi-drug resistant (MDR) smear-positive pulmonary tuberculosis (TB) were recruited into this open-label multicenter study. |
Pre-assignment Details | Patients were confirmed sputum positive for tubercule bacilli on smear microscopy. DS-TB patients were required to be sensitive to rifampicin and newly diagnosed with pulmonary TB (or untreated for at least 3 years). MDR-TB patients were required to be resistant to rifampicin. Both DS and MDR-TB patients could be sensitive/resistant to isoniazid. |
Arm/Group Title | DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide | DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | DS-TB: 2 Months HRZE / 4 Months HR | MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide |
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Patients with DS-TB were randomized to receive 400 milligrams (mg) moxifloxacin + 100 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24. | Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24. | Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24. | Patients with DS-TB were randomized to receive 150 mg rifampicin + 75 mg isoniazid + 400 mg pyrazinamide + 275 mg ethambutol combination tablets (HRZE) orally once daily from Weeks 1 to 8 during the treatment period. Patients then received 150 mg rifiampicin + 75 mg isoniazid combination tablets (HR) orally once daily from Weeks 9 to 26 during the treatment period. The daily dose of HRZE and HR was calculated based on patients' weight. Patients then entered a follow-up period up to Month 24. | Patients with MDR-TB received 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24. |
Period Title: Overall Study | |||||
Started | 65 | 71 | 67 | 68 | 13 |
Completed Month 12 Follow-Up | 43 | 52 | 49 | 57 | 10 |
Completed Month 24 Follow-Up | 40 | 47 | 46 | 53 | 10 |
Completed [1] | 57 | 63 | 52 | 59 | 10 |
Not Completed | 8 | 8 | 15 | 9 | 3 |
Reason Not Completed | |||||
Treatment non-compliance | 1 | 0 | 0 | 1 | 0 |
Late exclusion: rifampicin resistance | 1 | 0 | 0 | 0 | 0 |
Adverse event/specific toxicity | 4 | 3 | 11 | 2 | 1 |
Lost to Follow-up | 1 | 0 | 0 | 0 | 0 |
Death | 1 | 2 | 1 | 0 | 1 |
Withdrawal by Subject | 0 | 1 | 0 | 1 | 0 |
Investigator/sponsor decision | 0 | 2 | 0 | 3 | 1 |
Pregnancy | 0 | 0 | 2 | 0 | 0 |
Late exclusion: pyrazinamide resistance | 0 | 0 | 1 | 0 | 0 |
Protocol Violation | 0 | 0 | 0 | 2 | 0 |
[1]
Completed Treatment
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Baseline Characteristics
Arm/Group Title | DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide | DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | DS-TB: 2 Months HRZE / 4 Months HR | MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | Total | |
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Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 100 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24. | Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 4 months during the treatment period (from Day 1 to Week 17). Patients then entered a follow-up period up to Month 24. | Patients with DS-TB were randomized to receive 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24. | Patients with DS-TB were randomized to receive 150 mg rifampicin + 75 mg isoniazid + 400 mg pyrazinamide + 275 mg ethambutol combination tablets (HRZE) orally once daily from Weeks 1 to 8 during the treatment period. Patients then received 150 mg rifiampicin + 75 mg isoniazid combination tablets (HR) orally once daily from Weeks 9 to 26 during the treatment period. The daily dose of HRZE and HR was calculated based on patients' weight. Patients then entered a follow-up period up to Month 24. | Patients with MDR-TB received 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily for 6 months during the treatment period (from Day 1 to Week 26). Patients then entered a follow-up period up to Month 24. | Total of all reporting groups | |
Overall Number of Baseline Participants | 65 | 71 | 67 | 68 | 13 | 284 | |
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The Safety analysis population included all patients who were randomized (for the DS-TB patients) or assigned (for the MDR-TB patients) to trial medication and who received at least 1 dose of trial medication. Patients were classified according to treatment received.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 65 participants | 71 participants | 67 participants | 68 participants | 13 participants | 284 participants | |
<=18 years |
2 3.1%
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2 2.8%
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2 3.0%
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0 0.0%
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0 0.0%
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6 2.1%
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Between 18 and 65 years |
63 96.9%
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67 94.4%
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65 97.0%
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67 98.5%
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13 100.0%
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275 96.8%
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>=65 years |
0 0.0%
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2 2.8%
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0 0.0%
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1 1.5%
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0 0.0%
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3 1.1%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 65 participants | 71 participants | 67 participants | 68 participants | 13 participants | 284 participants | |
Female |
14 21.5%
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23 32.4%
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23 34.3%
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20 29.4%
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7 53.8%
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87 30.6%
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Male |
51 78.5%
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48 67.6%
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44 65.7%
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48 70.6%
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6 46.2%
|
197 69.4%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 65 participants | 71 participants | 67 participants | 68 participants | 13 participants | 284 participants | |
Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Not Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
65 100.0%
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71 100.0%
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67 100.0%
|
68 100.0%
|
13 100.0%
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284 100.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 65 participants | 71 participants | 67 participants | 68 participants | 13 participants | 284 participants |
Asian |
3 4.6%
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6 8.5%
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6 9.0%
|
4 5.9%
|
0 0.0%
|
19 6.7%
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Black or African American |
45 69.2%
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49 69.0%
|
45 67.2%
|
44 64.7%
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8 61.5%
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191 67.3%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
|
0 0.0%
|
1 1.5%
|
0 0.0%
|
1 0.4%
|
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White |
3 4.6%
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3 4.2%
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3 4.5%
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3 4.4%
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2 15.4%
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14 4.9%
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Mixed Race |
8 12.3%
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12 16.9%
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8 11.9%
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13 19.1%
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3 23.1%
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44 15.5%
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Other |
6 9.2%
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1 1.4%
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5 7.5%
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3 4.4%
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0 0.0%
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15 5.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
Following 3 deaths associated with hepatotoxicity, recruitment was suspended, followed by a partial clinical hold by the United States Food and Drug Association. The hold was removed but the Sponsor permanently stopped recruitment in December 2016.
More Information
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: | Leandra Lombard, Director, Clinical Operations |
Organization: | TB Alliance |
Phone: | +27 87 700 3900 |
EMail: | Leandra.Lombard@tballiance.org |
Responsible Party: | Global Alliance for TB Drug Development |
ClinicalTrials.gov Identifier: | NCT02342886 |
Other Study ID Numbers: |
NC-006-(M-PA-Z) |
First Submitted: | October 14, 2014 |
First Posted: | January 21, 2015 |
Results First Submitted: | February 2, 2019 |
Results First Posted: | March 26, 2019 |
Last Update Posted: | March 26, 2019 |