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Assessing PA-824 for Tuberculosis (the APT Trial) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT02256696•Johns Hopkins University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of expectorated sputum or Gene Xpert positive sputum sample. Patients having extra-pulmonary manifestations of tuberculosis, in addition to smear-positive pulmonary disease, are eligible for enrollment.
•2. Age \> 18 years
•3. . Weight ≥ 40 kg and ≤ 80 kg
•4. Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs)
•5. . Signed informed consent
•6. . HIV negative, or positive with CD4 ≥350 cells/cu mm and not currently taking or planning to take combination antiretroviral therapy for HIV during the study.
•7. Ability to adhere with study follow-up
•8 Agrees to adhere to contraceptive requirements
•\-

Exclusion Criteria

•1. Pregnant or breast-feeding
•2. Known intolerance or allergy to any of the study drugs
•3. Concomitant disorders or conditions for which isoniazid, rifampin, rifabutin, pyrazinamide, or ethambutol is contraindicated. These include severe hepatic damage, acute liver disease of any cause, allergy to the drug, and acute uncontrolled gouty arthritis.
•4. Current or planned therapy, during the intensive phase of TB therapy with cyclosporine or tacrolimus, which have unacceptable interactions with rifamycins.
•5. Any medical or psychosocial condition, which, in the view of the study investigator, makes study participation inadvisable.
•6. Pulmonary silicosis
•7. Central nervous system TB
•8. ECG at screening with corrected QT interval (QTc) (Fridericia correction) interval \>450 ms or any clinically-significant, in the opinion of the investigator, ECG abnormality
•9. History and/or presence (or evidence) of neuropathy or epilepsy.
•10. History of lens opacity or evidence of lens opacity on slit lamp ophthalmologic examination with a value of 1.0 or higher on age-related eye disease scale 2 (AREDS2) Clinical Lens Opacity Classification and Grading System scale.
+9 more criteria

Locations (1)

University of Cape Town Lung Institute

Cape Town, South Africa

Key Dates

Start Date

April 29, 2015

Primary Completion Date

May 1, 2022

Completion Date

May 1, 2022

Last Updated

July 18, 2023

Enrollment

157

ACTUAL participants

Conditions

Pulmonary Tuberculosis

Interventions

PA-824

DRUG

Rifampin

DRUG

Rifabutin

DRUG

Pyrazinamide

DRUG

Ethambutol

DRUG

Isoniazid

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessing PA-824 for Tuberculosis (the APT Trial)

Inclusion Criteria

Exclusion Criteria

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