Pulmonary Tuberculosis
Conditions
Keywords
Early Bactericidal Activity, EBA, Pulmonary Tuberculosis, PA-824, pretomanid
Brief summary
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive standard TB treatment.
Detailed description
The planned sample size of 15 participants per treatment group is in keeping with other Phase II trials of this type and accounts for the possibility of up to 3 drop-outs per arm, which based on previous studies of this type conducted at these sites, represents a conservative estimate of the expected drop-out rate.
Interventions
DRUGPA-824
50mg
275 mg
Sponsors
Global Alliance for TB Drug Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Informed Consent * Body weight between 40 and 90 kg, inclusive. * Newly diagnosed, previously untreated, uncomplicated, sputum smear-positive, pulmonary TB. * A chest X-ray compatible with TB. * Sputum positive * Adequate volume of sputum * Female participants of childbearing potential negative serum pregnancy and agree to use birth control * Male participants must agree to use contraception throughout participation in the trial and for 12 weeks after last dose.
Exclusion criteria
* Poor general condition * Rifampicin-resistant and/or Isoniazid-resistant * MTB Treatment received within the 3 months prior * Allergy to the IMP or related substances * Evidence of extrathoracic TB * A history of previous TB * Evidence of serious lung conditions other than TB or uncontrolled obstructive bronchial disease * History of lens opacity or evidence of lens opacity on slit lamp ophthalmologic examination * Any evidence of renal impairment * For males, any evidence or history of abnormality in the reproductive system * History and/or presence (or evidence) of neuropathy or epilepsy. * Clinically relevant changes in the ECG * A history of or current clinically relevant cardiovascular disorder * Concomitant use of any drug known to prolong QTc interval * Diabetics using insulin * Evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied). * Any diseases or conditions in which the use of the standard TB drugs or any of their components is contra-indicated, including but not limited to allergy to any TB drug, their component or to the IMP. * Any disease or conditions in which any of the medicinal products listed in the section pertaining to prohibited medication is used. * alcohol or drug abuse * Administration of an IMP prior to Visit 1, within 5 half-lives for that IMP if known. If the half-life of the IMP is unknown within 1 month. * Pregnant, breast-feeding, or planning to conceive or father a child within twelve weeks of cessation of treatment for males and within one week of cessation of treatment for females. * Use of any drugs or substances within 30 days prior to dosing known to be strong inhibitors or inducers of cytochrome P450 enzymes * Any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine) within 30 days prior to dosing. * glucocorticoids within one year prior to dosing. * HIV infection with helper/inducer T lymphocyte (CD4 cell) count of less than or equal to 300x10-6/L. * Receiving antiretroviral therapy (ART).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | 14 consecutive days of treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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). | Days 2-14 of 14 consecutive days of treatment |
| Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14). | Fourteen consecutive days of treatment |
| Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2). | Two consecutive days of treatment |
| Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14). | Days 2-14 of 14 consecutive days of treatment |
| 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). | Two consecutive days of treatment |
| Pharmacokinetics- Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC 0 to Infinity) (Day 1). | 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 |
| Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 1). | 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 |
| Pharmacokinetics-Maximum Observed Plasma Concentration (Cmax) (Day 14). | 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 |
| Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 14). | 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 |
| Pharmacokinetics- Maximum Observed Plasma Concentration (Cmax) (Day 1). | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PA-824 50 mg/qd PA-824 : 50mg oral tablet | 15 |
| PA-824 100mg/qd PA-824 : 100mg oral tablet | 15 |
| PA-824 150mg/qd PA-824 : 150 mg oral tablet | 15 |
| PA-824 200mg/qd PA-824 : 200 mg oral tablet | 16 |
| Rifafour e-275mg 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). | 8 |
| Total | 69 |
Baseline characteristics
| Characteristic | PA-824 100mg/qd | PA-824 150mg/qd | PA-824 200mg/qd | PA-824 50 mg/qd | Rifafour e-275mg | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 16 Participants | 15 Participants | 8 Participants | 69 Participants |
| Age, Continuous | 29.6 years STANDARD_DEVIATION 9.28 | 26.9 years STANDARD_DEVIATION 8.91 | 25.3 years STANDARD_DEVIATION 6.18 | 30.5 years STANDARD_DEVIATION 9.76 | 33.3 years STANDARD_DEVIATION 14.09 | 28.6 years STANDARD_DEVIATION 9.45 |
| Region of Enrollment South Africa | 15 participants | 15 participants | 16 participants | 15 participants | 8 participants | 69 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 9 Participants | 8 Participants | 2 Participants | 34 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 7 Participants | 7 Participants | 6 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 15 | 5 / 15 | 5 / 15 | 7 / 16 | 4 / 8 |
| serious Total, serious adverse events | 1 / 15 | 0 / 15 | 0 / 15 | 1 / 16 | 0 / 8 |
Outcome results
Primary
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).
Time frame: 14 consecutive days of treatment
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA-824 50 mg/qd | 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). | 0.063 log10CFU/ml/day | Standard Deviation 0.058 |
| PA-824 100mg/qd | 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). | 0.091 log10CFU/ml/day | Standard Deviation 0.073 |
| PA-824 150mg/qd | 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). | 0.078 log10CFU/ml/day | Standard Deviation 0.074 |
| PA-824 200mg/qd | 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). | 0.112 log10CFU/ml/day | Standard Deviation 0.07 |
| Rifafour e-275mg | 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). | 0.177 log10CFU/ml/day | Standard Deviation 0.042 |
Secondary
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).
Time frame: Two consecutive days of treatment
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA-824 50 mg/qd | 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). | 0.093 log10CFU/ml/day | Standard Deviation 0.211 |
| PA-824 100mg/qd | 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). | 0.111 log10CFU/ml/day | Standard Deviation 0.332 |
| PA-824 150mg/qd | 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). | -0.009 log10CFU/ml/day | Standard Deviation 0.29 |
| PA-824 200mg/qd | 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). | 0.160 log10CFU/ml/day | Standard Deviation 0.255 |
| Rifafour e-275mg | 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). | 0.470 log10CFU/ml/day | Standard Deviation 0.316 |
Secondary
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).
Time frame: Days 2-14 of 14 consecutive days of treatment
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA-824 50 mg/qd | 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). | 0.059 log10CFU/ml/day | Standard Deviation 0.06 |
| PA-824 100mg/qd | 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). | 0.088 log10CFU/ml/day | Standard Deviation 0.085 |
| PA-824 150mg/qd | 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). | 0.096 log10CFU/ml/day | Standard Deviation 0.98 |
| PA-824 200mg/qd | 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). | 0.104 log10CFU/ml/day | Standard Deviation 0.083 |
| Rifafour e-275mg | 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). | 0.128 log10CFU/ml/day | Standard Deviation 0.07 |
Secondary
Pharmacokinetics- Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC 0 to Infinity) (Day 1).
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA-824 50 mg/qd | Pharmacokinetics- Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC 0 to Infinity) (Day 1). | 11923.94 ng * hour/mL | Standard Deviation 4512.94 |
| PA-824 100mg/qd | Pharmacokinetics- Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC 0 to Infinity) (Day 1). | 18408.59 ng * hour/mL | Standard Deviation 7665.35 |
| PA-824 150mg/qd | Pharmacokinetics- Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC 0 to Infinity) (Day 1). | 28654.83 ng * hour/mL | Standard Deviation 10924.23 |
| PA-824 200mg/qd | Pharmacokinetics- Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC 0 to Infinity) (Day 1). | 38485.04 ng * hour/mL | Standard Deviation 16606.96 |
Secondary
Pharmacokinetics- Maximum Observed Plasma Concentration (Cmax) (Day 1).
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA-824 50 mg/qd | Pharmacokinetics- Maximum Observed Plasma Concentration (Cmax) (Day 1). | 465.3 ng/mL | Standard Deviation 150.6 |
| PA-824 100mg/qd | Pharmacokinetics- Maximum Observed Plasma Concentration (Cmax) (Day 1). | 662.3 ng/mL | Standard Deviation 167.8 |
| PA-824 150mg/qd | Pharmacokinetics- Maximum Observed Plasma Concentration (Cmax) (Day 1). | 994.7 ng/mL | Standard Deviation 305.7 |
| PA-824 200mg/qd | Pharmacokinetics- Maximum Observed Plasma Concentration (Cmax) (Day 1). | 1183.0 ng/mL | Standard Deviation 382.5 |
Secondary
Pharmacokinetics-Maximum Observed Plasma Concentration (Cmax) (Day 14).
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA-824 50 mg/qd | Pharmacokinetics-Maximum Observed Plasma Concentration (Cmax) (Day 14). | 777.3 ng/mL | Standard Deviation 250.7 |
| PA-824 100mg/qd | Pharmacokinetics-Maximum Observed Plasma Concentration (Cmax) (Day 14). | 1116.5 ng/mL | Standard Deviation 357.4 |
| PA-824 150mg/qd | Pharmacokinetics-Maximum Observed Plasma Concentration (Cmax) (Day 14). | 1543.9 ng/mL | Standard Deviation 511.4 |
| PA-824 200mg/qd | Pharmacokinetics-Maximum Observed Plasma Concentration (Cmax) (Day 14). | 2223.8 ng/mL | Standard Deviation 734.5 |
Secondary
Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 1).
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA-824 50 mg/qd | Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 1). | 16.142 hours | Standard Deviation 5.501 |
| PA-824 100mg/qd | Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 1). | 18.597 hours | Standard Deviation 9.459 |
| PA-824 150mg/qd | Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 1). | 19.005 hours | Standard Deviation 7.349 |
| PA-824 200mg/qd | Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 1). | 21.092 hours | Standard Deviation 6.49 |
Secondary
Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 14).
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA-824 50 mg/qd | Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 14). | 18.645 hour | Standard Deviation 5.394 |
| PA-824 100mg/qd | Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 14). | 19.274 hour | Standard Deviation 10.249 |
| PA-824 150mg/qd | Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 14). | 20.207 hour | Standard Deviation 5.288 |
| PA-824 200mg/qd | Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 14). | 23.811 hour | Standard Deviation 8.067 |
Secondary
Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14).
Time frame: Fourteen consecutive days of treatment
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA-824 50 mg/qd | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14). | 2.621 hours/day | Standard Deviation 2.534 |
| PA-824 100mg/qd | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14). | 4.969 hours/day | Standard Deviation 3.644 |
| PA-824 150mg/qd | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14). | 4.633 hours/day | Standard Deviation 3.687 |
| PA-824 200mg/qd | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14). | 4.640 hours/day | Standard Deviation 3.447 |
| Rifafour e-275mg | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14). | 13.364 hours/day | Standard Deviation 3.979 |
Secondary
Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2).
Time frame: Two consecutive days of treatment
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA-824 50 mg/qd | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2). | 1.483 hours/day | Standard Deviation 8.153 |
| PA-824 100mg/qd | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2). | -1.345 hours/day | Standard Deviation 8.586 |
| PA-824 150mg/qd | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2). | 4.867 hours/day | Standard Deviation 12.755 |
| PA-824 200mg/qd | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2). | 3.096 hours/day | Standard Deviation 8.202 |
| Rifafour e-275mg | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2). | 37.016 hours/day | Standard Deviation 5.639 |
Secondary
Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14).
Time frame: Days 2-14 of 14 consecutive days of treatment
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PA-824 50 mg/qd | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14). | 2.958 hours/day | Standard Deviation 2.652 |
| PA-824 100mg/qd | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14). | 5.744 hours/day | Standard Deviation 3.973 |
| PA-824 150mg/qd | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14). | 4.594 hours/day | Standard Deviation 5.035 |
| PA-824 200mg/qd | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14). | 5.391 hours/day | Standard Deviation 3.608 |
| Rifafour e-275mg | Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14). | 9.422 hours/day | Standard Deviation 4.367 |