Phase 2
N=69
PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
Pulmonary Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT00567840 ↗Enrolled (actual)
69
Serious AEs
2.9%
Results posted
Apr 2017
Primary outcome: 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). — 0.106; 0.107; 0.091; 0.088 log10 CFU/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PA-824 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Global Alliance for TB Drug Development
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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). |
0.106; 0.107; 0.091; 0.088; 0.148 | — |
| 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). |
0.109; 0.096; 0.025; -0.035; 0.403 | — |
| 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). |
0.106; 0.113; 0.095; 0.113; 0.112 | — |
| SECONDARY EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14) |
3.818; 4.776; 4.865; 4.440; 9.741 | — |
| SECONDARY EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-2) |
1.115; 5.788; 2.795; 1.400; 24.125 | — |
| 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] |
3.833; 5.09; 4.069; 4.868; 7.344 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- informed consent
- M/F 18-64 yo
- newly diagnosed pulmonary TB
- sputum positive
- adequate contraception
Exclusion Criteria
- poor health
- rifampicin resistance
- treatment with other anti TB agents in last 3 mos.
- extrapulmonary TB
- COPD
- neuropathy
- ECG wih QRS prolongation ove 120 msec
- CV disorder
- diabetes requiring insulin
- Metabolic disease
- drug/alcohol abuse
- pregnancy
- use of substances that are strong inhibitors/inducers of CYP450
- use of ARV
Data sourced from ClinicalTrials.gov (NCT00567840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.