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

April 10, 2017 updated by: Global Alliance for TB Drug Development

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Cape Province
      • Cape Town, Cape Province, South Africa, 8000
        • Tiervlei Trials Center, Stellenbosch University
      • Cape Town, Cape Province, South Africa
        • University of Cape Town Lung Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
PA-824 200 mg/qd
Drug: PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
Other Names:
  • Rifafour e-275
Experimental: 2
PA-824 600 mg/qd
Drug: PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
Other Names:
  • Rifafour e-275
Experimental: 3
PA-824 1000 mg/qd
Drug: PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
Other Names:
  • Rifafour e-275
Experimental: 4
PA-824 1200 mg/qd
Drug: PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
Other Names:
  • Rifafour e-275
Active Comparator: 5
Rifafour e-275 mg
Drug: PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
Other Names:
  • Rifafour e-275

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14).
Time Frame: Day 0 and Day 14
Day 0 and Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-2).
Time Frame: Day 0 and Day 2
Day 0 and Day 2
Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 2-14).
Time Frame: Day 2 and Day 14
Day 2 and Day 14
EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)
Time Frame: Day 0 and Day 14
Day 0 and Day 14
EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-2)
Time Frame: Day 0 and Day 2
Day 0 and Day 2
EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 2-14) Show Description: [Not Specified]
Time Frame: Day 2 and Day 14
Day 2 and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Global Alliance for TB Drug Development

Investigators

  • Principal Investigator: Rodney Dawson, MD, UCT Lung institute
  • Principal Investigator: Andreas Diacon, MD, Tiervlei Trial Center, Stelennbosch University, South Africa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 4, 2007

First Posted (Estimate)

December 5, 2007

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA-824-CL-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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