PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis

Global Alliance for TB Drug Development

Status and phase: Completed; Phase 2

Conditions: Pulmonary Tuberculosis

Treatments: Drug: PA-824

Study type: Interventional

Funder types: Other

Identifiers

NCT00567840

PA-824-CL-007

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

69 participants in 5 patient groups

1

Experimental group

Description:

PA-824 200 mg/qd

Treatment:

Drug: PA-824

2

Experimental group

Description:

PA-824 600 mg/qd

Treatment:

Drug: PA-824

3

Experimental group

Description:

PA-824 1000 mg/qd

Treatment:

Drug: PA-824

4

Experimental group

Description:

PA-824 1200 mg/qd

Treatment:

Drug: PA-824

5

Active Comparator group

Description:

Rifafour e-275 mg

Treatment:

Drug: PA-824