NCT02256696

Assessing PA-824 for Tuberculosis (the APT Trial)

A Phase 2 Randomized, Open-Label Trial of PA-824-Containing Regimens Versus Standard Treatment for Drug-Sensitive Sputum Smear-Positive Pulmonary Tuberculosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Assess the mycobactericidal activity of PA-824 (given at 200 mg daily) when added to first-line tuberculosis (TB) treatment (isoniazid, pyrazinamide, and a rifamycin antibiotic) over 12 weeks of treatment. Funding Source - FDA Office of Orphan Products Development (OOPD)

Detailed description

Phase IIB, 12-week, open-label, single-site, randomized clinical trial with three treatment groups. Patients with drug-sensitive TB will all receive once daily isoniazid and pyrazinamide for 8 weeks followed by 4 weeks of daily isoniazid. In addition, Arm 1 participants will receive PA-824 200 mg daily and rifampin 600 mg daily for 12 weeks. Arm 2 participants will receive PA-824 200 mg daily and rifabutin 300 mg daily for 12 weeks. Arm 3 participants (control group) will receive rifampin for 12 weeks and ethambutol for 8 weeks. Patients will be screened within 1 week of TB diagnosis, will receive 12 weeks of study treatment and will return for follow-up visits at 4, 12, and 36 weeks after study treatment completion. All patients will be referred to the local TB treatment program after completion of study treatment to finish their 24-week TB treatment course.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
DRUG	PA-824	200 mg QD
DRUG	Rifampin	600 mg QD
DRUG	Rifabutin	300 mg QD
DRUG	Pyrazinamide	25mg/kg QD
DRUG	Ethambutol	15mg/kg QD
DRUG	Isoniazid	300 mg QD

Timeline

• Start date: 2015-04-29
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2014-10-06
• Last updated: 2023-07-18
• Results posted: 2023-07-18

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated drug study