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The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard TB treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | PA-824 200 mg/qd |
|
| 2 | Experimental | PA-824 600 mg/qd |
|
| 3 | Experimental | PA-824 1000 mg/qd |
|
| 4 | Experimental | PA-824 1200 mg/qd |
|
| 5 | Active Comparator | Rifafour e-275 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PA-824 | Drug | 200 mg, 600 mg, 100 mg, 1200 mg qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14). | Day 0 and Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-2). | Day 0 and Day 2 | |
| Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 2-14). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodney Dawson, MD | UCT Lung Institute | Principal Investigator |
| Andreas Diacon, MD | Tiervlei Trial Center, Stelennbosch University, South Africa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tiervlei Trials Center, Stellenbosch University | Cape Town | Cape Province | 8000 | South Africa | ||
| University of Cape Town Lung Institute |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PA-824 200 mg | PA-824: 200 mg per day for 14 consecutive days |
| FG001 | PA-824 600 mg | PA-824: 600 mg per day for 14 consecutive days |
| FG002 | PA-824 1000 mg | PA-824: 1000 mg per day for 14 consecutive days |
| FG003 | PA-824 1200 mg | PA-824: 1200 mg per day for 14 consecutive days |
| FG004 | Rifafour | Rifafour e-275 on Days 1 to 14, dosed by weight |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PA-824 200 mg | PA-824: 200 mg per day for 14 consecutive days |
| BG001 | PA-824 600 mg | PA-824: 600 mg per day for 14 consecutive days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14). | Some of the EBA values could not be calculated due to missing results. The number of participants given are the number of participants for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated. | Posted | Mean | Standard Deviation | log10 CFU/ml | Day 0 and Day 14 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PA-824 200 mg | PA-824: 200 mg per day for 14 consecutive days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel E. Everitt, MD, Vice President and Senior Medical Officer | Global Alliance for TB Drug Development | 212-227-7540 | Dan.Everitt@tballiance.org |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| C410767 | pretomanid |
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| Day 2 and Day 14 |
| EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14) | Day 0 and Day 14 |
| EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-2) | Day 0 and Day 2 |
| EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 2-14) Show Description: [Not Specified] | Day 2 and Day 14 |
| Cape Town |
| Cape Province |
| South Africa |
| BG002 | PA-824 1000 mg | PA-824: 1000 mg per day for 14 consecutive days |
| BG003 | PA-824 1200 mg | PA-824: 1200 mg per day for 14 consecutive days |
| BG004 | Rifafour | Rifafour e-275 on Days 1 to 14, dosed by weight |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | PA-824 1000 mg | PA-824: 1000 mg per day for 14 consecutive days |
| OG003 | PA-824 1200 mg | PA-824: 1200 mg per day for 14 consecutive days |
| OG004 | Rifafour | Rifafour e-275 on Days 1 to 14, dosed by weight |
|
|
| Secondary | Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-2). | Some of the EBA values could not be calculated due to missing results. The number of participants given are the number of participants for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated. | Posted | Mean | Standard Deviation | log10 CFU/ml | Day 0 and Day 2 |
|
|
|
| Secondary | Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 2-14). | Some of the EBA values could not be calculated due to missing results. The number of participants given are the number of participants for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated. | Posted | Mean | Standard Deviation | log10 CFU/ml | Day 2 and Day 14 |
|
|
|
| Secondary | EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14) | Posted | Mean | Standard Deviation | hours/day | Day 0 and Day 14 |
|
|
|
| Secondary | EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-2) | Posted | Mean | Standard Deviation | hours/day | Day 0 and Day 2 |
|
|
|
| Secondary | EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 2-14) Show Description: [Not Specified] | Posted | Mean | Standard Deviation | hours/day | Day 2 and Day 14 |
|
|
|
| 1 |
| 15 |
| 6 |
| 15 |
| EG001 | PA-824 600 mg | PA-824: 600 mg per day for 14 consecutive days | 0 | 15 | 4 | 15 |
| EG002 | PA-824 1000 mg | PA-824: 1000 mg per day for 14 consecutive days | 0 | 16 | 5 | 16 |
| EG003 | PA-824 1200 mg | PA-824: 1200 mg per day for 14 consecutive days | 0 | 15 | 7 | 15 |
| EG004 | Rifafour | Rifafour e-275 on Days 1 to 14, dosed by weight | 1 | 8 | 2 | 8 |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 |
|
| Pruritus Generalized | Skin and subcutaneous tissue disorders | MedDRA 10.1 |
|
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA 10.1 |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 10.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.1 |
|
| Lip Ulceration | Gastrointestinal disorders | MedDRA 10.1 |
|
| Toothache | Gastrointestinal disorders | MedDRA 10.1 |
|
| Atrioventricular Block First Degree | Cardiac disorders | MedDRA 10.1 |
|
| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA 10.1 |
|
| Wolff-Parkinson-White Syndrome | Cardiac disorders | MedDRA 10.1 |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 |
|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 |
|
| Electrocardiogram QT corrected Interval Prolonged | Investigations | MedDRA 10.1 |
|
| Hepatic Enzyme Increased | Investigations | MedDRA 10.1 |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 |
|
| Pain in the Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.1 |
|
| Dizziness | Nervous system disorders | MedDRA 10.1 |
|
| Dizziness Postural | Nervous system disorders | MedDRA 10.1 |
|
| Eye Pruritus | Eye disorders | MedDRA 10.1 |
|
| Chest Pain | General disorders | MedDRA 10.1 | and Administration Site Conditions |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 10.1 |
|
| Confusional State | Psychiatric disorders | MedDRA 10.1 |
|
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.
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |