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

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ClinicalTrials.gov Identifier: NCT00567840
Recruitment Status : Completed
First Posted : December 5, 2007
Results First Posted : April 4, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by:
Global Alliance for TB Drug Development

Tracking Information
First Submitted Date  ICMJE December 4, 2007
First Posted Date  ICMJE December 5, 2007
Results First Submitted Date  ICMJE February 15, 2017
Results First Posted Date  ICMJE April 4, 2017
Last Update Posted Date May 15, 2017
Study Start Date  ICMJE August 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2007)
EBA measured as the rate of change in log CFUs (Colony forming units) in sputum [ Time Frame: 14 days of consecutive treatment ]
Change History Complete list of historical versions of study NCT00567840 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2007)
Proportion of pts with SAEs and proportion of patients who discontinue due to an AE [ Time Frame: 14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Tuberculosis
Intervention  ICMJE Drug: PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
Other Name: Rifafour e-275
Study Arms  ICMJE
  • Experimental: 1
    PA-824 200 mg/qd
    Intervention: Drug: PA-824
  • Experimental: 2
    PA-824 600 mg/qd
    Intervention: Drug: PA-824
  • Experimental: 3
    PA-824 1000 mg/qd
    Intervention: Drug: PA-824
  • Experimental: 4
    PA-824 1200 mg/qd
    Intervention: Drug: PA-824
  • Active Comparator: 5
    Rifafour e-275 mg
    Intervention: Drug: PA-824
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2017)
69
Original Actual Enrollment  ICMJE
 (submitted: December 4, 2007)
68
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00567840
Other Study ID Numbers  ICMJE PA-824-CL-007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Andreas Diacon, Tiervlei Trial Center, University of Stellenbosch, South Africa
Study Sponsor  ICMJE Global Alliance for TB Drug Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rodney Dawson, MD UCT Lung Institute
Principal Investigator: Andreas Diacon, MD Tiervlei Trial Center, Stelennbosch University, South Africa
PRS Account Global Alliance for TB Drug Development
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP