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Assessing PA-824 for Tuberculosis (the APT Trial)

NCT02256696 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2023-07-18

Study results available
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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)

Conditions

  • Pulmonary Tuberculosis

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Kelly E Dooley, MD PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-29
Primary Completion
2022-05-01
Completion
2022-05-01
FDA Drug
Yes

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02256696 on ClinicalTrials.gov