A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis. (NC-005)

• ClinicalTrials.gov Identifier: NCT02193776
• Recruitment Status: Completed
• First Posted: July 18, 2014
• Results First Posted: July 26, 2019
• Last Update Posted: July 26, 2019
• Sponsor: Global Alliance for TB Drug Development
• 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: Tuberculosis
• Interventions: Drug: PA-824; Drug: bedaquiline; Drug: moxifloxacin; Drug: pyrazinamide; Drug: isoniazid, rifampicin, pyrazinamide and ethambutol combination tablet
• Enrollment: 240

Participant Flow

Recruitment Details	This trial was conducted at 10 centers in 3 countries (South Africa, Tanzania, and Uganda) from 23 October 2014. Adult male and female participants with drug-sensitive (DS) or multi-drug resistant (MDR) smear-positive pulmonary tuberculosis (TB) were recruited into this open-label multi-center study.
Pre-assignment Details	Participants were confirmed positive for M.tuberculosis on molecular test. DS-TB participants were to be sensitive to rifampicin and newly diagnosed with pulmonary TB (or untreated for at least 3 years). MDR-TB participants were to be resistant to rifampicin, sensitive to moxifloxacin and newly diagnosed with pulmonary TB (or treated for <=7 days).

Arm/Group Title	DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide	DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide	DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol)	MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
Arm/Group Description	Participants with DS-TB were randomized to receive 400 milligrams (mg) bedaquiline once daily on Days 1 to 14, 200 mg three times a week (t.i.w) during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.	Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.	Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kilograms (kg): 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26.	Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
Period Title: Overall Study
Started	59	60	61	60
Completed Day 70 Follow-up	54	56	60	60
Completed Day 140 Follow-up	52	52	58	58
Completed [1]	51	53	59	58
Not Completed	8	7	2	2
Reason Not Completed
Consent withdrawn	1	0	0	0
Failure to comply with protocol	0	1	0	0
Investigator/Sponsor decision	1	1	0	0
Death	1	0	0	0
Adverse event/Specific toxicity	5	5	2	2
[1] Completed Treatment

Baseline Characteristics

Arm/Group Title		DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide	DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide	DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol)	MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide	Total
Arm/Group Description		Participants with DS-TB were randomized to receive 400 mg bedaquiline once daily on Days 1 to 14, 200 mg t.i.w during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.	Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.	Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kg: 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26.	Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.	Total of all reporting groups
Overall Number of Baseline Participants		59	60	61	60	240
Baseline Analysis Population Description		The safety analysis population included all participants who were randomized (for the DS participant population) or assigned (for the MDR participant population) to study drug and who received at least 1 administration of study drug.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	59 participants	60 participants	61 participants	60 participants	240 participants
		35.1 (13.03)	33.9 (10.45)	33.3 (8.60)	34.0 (12.68)	34.1 (11.26)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	59 participants	60 participants	61 participants	60 participants	240 participants
	Female	14 23.7%	12 20.0%	15 24.6%	17 28.3%	58 24.2%
	Male	45 76.3%	48 80.0%	46 75.4%	43 71.7%	182 75.8%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	59 participants	60 participants	61 participants	60 participants	240 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	1 1.7%	1 0.4%
	Black or African American	46 78.0%	49 81.7%	49 80.3%	53 88.3%	197 82.1%
	White	0 0.0%	0 0.0%	0 0.0%	1 1.7%	1 0.4%
	More than one race	13 22.0%	11 18.3%	12 19.7%	5 8.3%	41 17.1%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Rate of Change in Time to Sputum Culture Positivity (TTP) Over 8 Weeks in the Mycobacterial Growth Indicator Tube (MGIT) System
Description	The bactericidal activity (BA) was determined by the rate of change in TTP collected from overnight sputum samples over 8 weeks of treatment in the liquid culture media MGIT system, represented by the model-fitted log(TTP) results as calculated by the regression of the observed log(TTP) results over time. The bactericidal activity of log(TTP) over Day 0 to Day 56 (BATTP[0-56]) was presented and expressed as the daily percentage change in TTP from Day 0 to Day 56. The mean BATTP (0-56) was calculated from Bayesian non-linear mixed effects regression models fitted to log(TTP) collected from sputum samples (observed from Day 0 to Day 56).
Time Frame	Day 0 to Day 56 (8 weeks)

Outcome Measure Data

Analysis Population Description

The modified intention-to-treat analysis population included all participants included in the safety analysis population for whom valid corresponding efficacy data were available. Pyrazinamide resistant participants were excluded from this analysis population (applicable to both participants with DS-TB and MDR-TB).

Arm/Group Title	DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide	DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide	DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol)	MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
Arm/Group Description:	Participants with DS-TB were randomized to receive 400 mg bedaquiline once daily on Days 1 to 14, 200 mg t.i.w during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.	Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.	Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kg: 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26.	Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
Overall Number of Participants Analyzed	57	56	59	37
Mean (Standard Deviation); Unit of Measure: percentage change in TTP/day
	4.878 (1.604)	5.182 (1.466)	4.046 (1.129)	5.194 (1.068)

2. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description	A TEAE was defined as any AE which started or worsened on or after first study drug administration up to and including the Day 70 follow-up visit (or up to and including 14 days after last study drug administration for participants not having Day 70 follow-up visit). Drug-related TEAEs were defined as TEAEs for which relationship to study drug was indicated as 'possible', 'probable', 'certain' or missing. TEAEs leading to death were defined as TEAEs resulted 'fatal' outcome. Serious TEAEs were defined as TEAEs for which serious was indicated as 'yes'. TEAEs leading to discontinuation of study drug were defined as TEAEs for which action taken with study drug was indicated as 'study drug stopped'. TEAEs leading to early withdrawal from study were defined as TEAEs resulted study discontinuation. Grade III and IV TEAEs were defined as TEAEs for which severity (DMID grade) was indicated as 'Grade 3 (severe)' and 'Grade 4 (potentially life-threatening)' or missing, respectively.
Time Frame	First study drug administration (Day 1) up to and including the Day 70 follow-up visit (or up to and including 14 days after last study drug administration for participants not having the Day 70 follow-up visit) (70 days)

Outcome Measure Data

Analysis Population Description

The safety analysis population included all participants who were randomized (for the DS participant population) or assigned (for the MDR participant population) to study drug and received at least 1 administration of study drug.

Arm/Group Title	DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide	DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide	DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol)	MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
Arm/Group Description:	Participants with DS-TB were randomized to receive 400 mg bedaquiline once daily on Days 1 to 14, 200 mg t.i.w during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.	Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.	Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kg: 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26.	Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
Overall Number of Participants Analyzed	59	60	61	60
Measure Type: Count of Participants; Unit of Measure: Participants
Any TEAE	50 84.7%	45 75.0%	44 72.1%	57 95.0%
Drug-related TEAE	38 64.4%	29 48.3%	29 47.5%	46 76.7%
TEAE leading to death	1 1.7%	1 1.7%	1 1.6%	0 0.0%
Any serious TEAE	4 6.8%	3 5.0%	4 6.6%	4 6.7%
Drug-related serious TEAE	2 3.4%	0 0.0%	1 1.6%	2 3.3%
TEAE leading to discontinuation of study drug	6 10.2%	5 8.3%	2 3.3%	2 3.3%
TEAE leading to early withdrawal from study	5 8.5%	5 8.3%	2 3.3%	2 3.3%
Grade III TEAE	19 32.2%	17 28.3%	14 23.0%	13 21.7%
Grade IV TEAE	8 13.6%	7 11.7%	2 3.3%	1 1.7%

Adverse Events

Time Frame	TEAEs were collected from first study drug administration (Day 1) up to and including the Day 70 follow-up visit (or up to and including 14 days after last study drug administration for participants not having the Day 70 follow-up visit) (70 days).
Adverse Event Reporting Description	The safety analysis population included all participants who were randomized (for the DS participant population) or assigned (for the MDR participant population) to study drug and received at least 1 administration of study drug. All-cause mortality is defined as death due to any cause for entire duration of study.
Arm/Group Title	DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide	DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide	DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol)	MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
Arm/Group Description	Participants with DS-TB were randomized to receive 400 mg bedaquiline once daily on Days 1 to 14, 200 mg t.i.w during Days 15 to 56 + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.	Participants with DS-TB were randomized to receive 200 mg bedaquiline + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.	Participants with DS-TB were randomized to receive combination tablets containing 75 mg isoniazid + 150 mg rifampicin + 400 mg pyrazinamide + 275 mg ethambutol orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8) with the daily dose per the participant's weight as follows: 30 to 37 kg: 2 tablets; 38 to 54 kg: 3 tablets; 55 to 70 kg: 4 tablets; 71 kg and over: 5 tablets. Participants then entered a follow-up period up to Month 26.	Participants with MDR-TB received 200 mg bedaquiline + 400 mg moxifloxacin + 200 mg pretomanid (PA-824) + 1500 mg pyrazinamide orally once daily on Days 1 to 56 during the treatment period (from Day 1 to Week 8). Participants then entered a follow-up period up to Month 26.
All-Cause Mortality
	DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide	DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide	DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol)	MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/59 (3.39%)	3/60 (5.00%)	2/61 (3.28%)	4/60 (6.67%)
Serious Adverse Events
	DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide	DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide	DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol)	MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	4/59 (6.78%)	3/60 (5.00%)	4/61 (6.56%)	4/60 (6.67%)
Blood and lymphatic system disorders
Anaemia † 1	0/59 (0.00%)	1/60 (1.67%)	0/61 (0.00%)	0/60 (0.00%)
Cardiac disorders
Pericardial effusion † 1	0/59 (0.00%)	1/60 (1.67%)	0/61 (0.00%)	0/60 (0.00%)
Hepatobiliary disorders
Drug-induced liver injury † 1	1/59 (1.69%)	0/60 (0.00%)	1/61 (1.64%)	0/60 (0.00%)
Acute hepatic failure † 1	0/59 (0.00%)	0/60 (0.00%)	1/61 (1.64%)	0/60 (0.00%)
Infections and infestations
Appendicitis † 1	1/59 (1.69%)	0/60 (0.00%)	0/61 (0.00%)	0/60 (0.00%)
Bronchopneumonia † 1	0/59 (0.00%)	0/60 (0.00%)	0/61 (0.00%)	1/60 (1.67%)
Gastroenteritis † 1	0/59 (0.00%)	0/60 (0.00%)	1/61 (1.64%)	0/60 (0.00%)
Malaria † 1	0/59 (0.00%)	1/60 (1.67%)	0/61 (0.00%)	0/60 (0.00%)
Pneumonia † 1	0/59 (0.00%)	1/60 (1.67%)	0/61 (0.00%)	0/60 (0.00%)
Pulmonary tuberculosis † 1	0/59 (0.00%)	0/60 (0.00%)	1/61 (1.64%)	0/60 (0.00%)
Investigations
Alanine aminotransferase increased † 1	1/59 (1.69%)	0/60 (0.00%)	0/61 (0.00%)	2/60 (3.33%)
Aspartate aminotransferase increased † 1	1/59 (1.69%)	0/60 (0.00%)	0/61 (0.00%)	2/60 (3.33%)
Renal and urinary disorders
Renal failure acute † 1	0/59 (0.00%)	0/60 (0.00%)	1/61 (1.64%)	0/60 (0.00%)
Respiratory, thoracic and mediastinal disorders
Haemoptysis † 1	0/59 (0.00%)	0/60 (0.00%)	1/61 (1.64%)	1/60 (1.67%)
Pneumothorax † 1	1/59 (1.69%)	0/60 (0.00%)	0/61 (0.00%)	0/60 (0.00%)
Pneumothorax spontaneous † 1	0/59 (0.00%)	1/60 (1.67%)	0/61 (0.00%)	0/60 (0.00%)
Pulmonary artery aneurysm † 1	0/59 (0.00%)	0/60 (0.00%)	0/61 (0.00%)	1/60 (1.67%)
Pulmonary oedema † 1	1/59 (1.69%)	0/60 (0.00%)	0/61 (0.00%)	0/60 (0.00%)
1 Term from vocabulary, MedDRA (17.1); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide	DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide	DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol)	MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	50/59 (84.75%)	45/60 (75.00%)	44/61 (72.13%)	57/60 (95.00%)
Blood and lymphatic system disorders
Anaemia † 1	1/59 (1.69%)	4/60 (6.67%)	0/61 (0.00%)	1/60 (1.67%)
Gastrointestinal disorders
Vomiting † 1	4/59 (6.78%)	1/60 (1.67%)	4/61 (6.56%)	7/60 (11.67%)
Nausea † 1	3/59 (5.08%)	1/60 (1.67%)	1/61 (1.64%)	5/60 (8.33%)
Diarrhoea † 1	3/59 (5.08%)	1/60 (1.67%)	0/61 (0.00%)	3/60 (5.00%)
Infections and infestations
Urinary tract infection † 1	2/59 (3.39%)	0/60 (0.00%)	2/61 (3.28%)	4/60 (6.67%)
Influenza † 1	3/59 (5.08%)	0/60 (0.00%)	3/61 (4.92%)	0/60 (0.00%)
Vulvovaginal candidiasis † 1	0/59 (0.00%)	0/60 (0.00%)	0/61 (0.00%)	4/60 (6.67%)
Investigations
Blood uric acid increased † 1	15/59 (25.42%)	13/60 (21.67%)	9/61 (14.75%)	27/60 (45.00%)
Alanine aminotransferase increased † 1	3/59 (5.08%)	5/60 (8.33%)	2/61 (3.28%)	2/60 (3.33%)
Aspartate aminotransferase increased † 1	3/59 (5.08%)	3/60 (5.00%)	3/61 (4.92%)	3/60 (5.00%)
Amylase increased † 1	0/59 (0.00%)	0/60 (0.00%)	1/61 (1.64%)	10/60 (16.67%)
Gamma-glutamyltransferase increased † 1	0/59 (0.00%)	2/60 (3.33%)	0/61 (0.00%)	6/60 (10.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	10/59 (16.95%)	5/60 (8.33%)	6/61 (9.84%)	13/60 (21.67%)
Myalgia † 1	5/59 (8.47%)	2/60 (3.33%)	1/61 (1.64%)	3/60 (5.00%)
Pain in extremity † 1	0/59 (0.00%)	2/60 (3.33%)	0/61 (0.00%)	4/60 (6.67%)
Nervous system disorders
Dizziness † 1	3/59 (5.08%)	1/60 (1.67%)	3/61 (4.92%)	1/60 (1.67%)
Renal and urinary disorders
Haematuria † 1	0/59 (0.00%)	0/60 (0.00%)	0/61 (0.00%)	4/60 (6.67%)
Respiratory, thoracic and mediastinal disorders
Haemoptysis † 1	1/59 (1.69%)	3/60 (5.00%)	6/61 (9.84%)	6/60 (10.00%)
Pleuritic pain † 1	0/59 (0.00%)	0/60 (0.00%)	0/61 (0.00%)	6/60 (10.00%)
Skin and subcutaneous tissue disorders
Pruritus generalised † 1	4/59 (6.78%)	4/60 (6.67%)	8/61 (13.11%)	2/60 (3.33%)
Pruritus † 1	3/59 (5.08%)	2/60 (3.33%)	3/61 (4.92%)	2/60 (3.33%)
Rash † 1	3/59 (5.08%)	0/60 (0.00%)	2/61 (3.28%)	1/60 (1.67%)
1 Term from vocabulary, MedDRA (17.1); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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: Almari Conradie, Director, Clinical Operations
• Organization: TB Alliance
• Phone: +27 12 991 6328
• EMail: almari.conradie@tballiance.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tweed CD, Dawson R, Burger DA, Conradie A, Crook AM, Mendel CM, Conradie F, Diacon AH, Ntinginya NE, Everitt DE, Haraka F, Li M, van Niekerk CH, Okwera A, Rassool MS, Reither K, Sebe MA, Staples S, Variava E, Spigelman M. Bedaquiline, moxifloxacin, pretomanid, and pyrazinamide during the first 8 weeks of treatment of patients with drug-susceptible or drug-resistant pulmonary tuberculosis: a multicentre, open-label, partially randomised, phase 2b trial. Lancet Respir Med. 2019 Dec;7(12):1048-1058. doi: 10.1016/S2213-2600(19)30366-2. Epub 2019 Nov 12.

• Responsible Party: Global Alliance for TB Drug Development
• ClinicalTrials.gov Identifier: NCT02193776
• Other Study ID Numbers: NC-005-(J-M-Pa-Z)
• First Submitted: July 16, 2014
• First Posted: July 18, 2014
• Results First Submitted: February 22, 2019
• Results First Posted: July 26, 2019
• Last Update Posted: July 26, 2019