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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567840
First Posted: December 5, 2007
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Global Alliance for TB Drug Development
  Purpose
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.

Condition Intervention Phase
Pulmonary Tuberculosis Drug: PA-824 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Global Alliance for TB Drug Development:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 69
Study Start Date: August 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PA-824 200 mg/qd
Drug: PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
Other Name: Rifafour e-275
Experimental: 2
PA-824 600 mg/qd
Drug: PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
Other Name: Rifafour e-275
Experimental: 3
PA-824 1000 mg/qd
Drug: PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
Other Name: Rifafour e-275
Experimental: 4
PA-824 1200 mg/qd
Drug: PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
Other Name: Rifafour e-275
Active Comparator: 5
Rifafour e-275 mg
Drug: PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
Other Name: Rifafour e-275

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567840


Locations
South Africa
Tiervlei Trials Center, Stellenbosch University
Cape Town, Cape Province, South Africa, 8000
University of Cape Town Lung Institute
Cape Town, Cape Province, South Africa
Sponsors and Collaborators
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
  More Information

Additional Information:
Responsible Party: Prof. Andreas Diacon, Tiervlei Trial Center, University of Stellenbosch, South Africa
ClinicalTrials.gov Identifier: NCT00567840     History of Changes
Other Study ID Numbers: PA-824-CL-007
First Submitted: December 4, 2007
First Posted: December 5, 2007
Results First Submitted: February 15, 2017
Results First Posted: April 4, 2017
Last Update Posted: May 15, 2017
Last Verified: January 2017

Keywords provided by Global Alliance for TB Drug Development:
Early Bactericidal Activity
EBA
pulmonary tuberculosis
PA-824
Pretomanid
CL-007

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections