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

Pulmonary Tuberculosis Clinical Trial

Official title:

A Phase IIa Trial to Evaluate the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of 14 Days' Treatment With Four Oral Doses of PA-824 in Adult Participants With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567840
• Other study ID #: PA-824-CL-007
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2007
• Last updated: January 12, 2016
• Start date: August 2007
• Est. completion date: December 2007

Study information

• Verified date: August 2015
• Source: Global Alliance for TB Drug Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd

Locations

Country	Name	City	State
South Africa	Tiervlei Trials Center, Stellenbosch University	Cape Town	Cape Province
South Africa	University of Cape Town Lung Institute	Cape Town	Cape Province

Sponsors (1)

Lead Sponsor	Collaborator
Global Alliance for TB Drug Development

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EBA measured as the rate of change in log CFUs (Colony forming units) in sputum		14 days of consecutive treatment	No
Secondary	Proportion of pts with SAEs and proportion of patients who discontinue due to an AE		14 days	Yes

External Links

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