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

This study has been completed.
Sponsor:
Information provided by:
Global Alliance for TB Drug Development
ClinicalTrials.gov Identifier:
NCT00567840
First received: December 4, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

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

Primary Outcome Measures:
  • EBA measured as the rate of change in log CFUs (Colony forming units) in sputum [ Time Frame: 14 days of consecutive treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of pts with SAEs and proportion of patients who discontinue due to an AE [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 68
Study Start Date: August 2007
Study Completion Date: December 2007
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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567840

Locations
South Africa
University of Cape Town Lung Institute
Cape Town, Cape Province, South Africa
Tiervlei Trials Center, Stellenbosch University
Cape Town, Cape Province, South Africa, 8000
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:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: December 4, 2007
Last Updated: December 4, 2007
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council

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

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

ClinicalTrials.gov processed this record on May 22, 2013