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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2007

Interventions

  • Drug: PA-824
    • 200 mg, 600 mg, 100 mg, 1200 mg qd

Arms, Groups and Cohorts

  • Experimental: 1
    • PA-824 200 mg/qd
  • Experimental: 2
    • PA-824 600 mg/qd
  • Experimental: 3
    • PA-824 1000 mg/qd
  • Experimental: 4
    • PA-824 1200 mg/qd
  • Active Comparator: 5
    • Rifafour e-275 mg

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Global Alliance for TB Drug Development
  • Provider of Information About this Clinical Study
    • Prof. Andreas Diacon, Tiervlei Trial Center, University of Stellenbosch, South Africa
  • Overall Official(s)
    • Rodney Dawson, MD, Principal Investigator, UCT Lung Institute
    • Andreas Diacon, MD, Principal Investigator, Tiervlei Trial Center, Stelennbosch University, South Africa

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