PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
NCT ID: NCT00567840
Last Updated: 2017-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2007-08-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
PA-824 200 mg/qd
PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
2
PA-824 600 mg/qd
PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
3
PA-824 1000 mg/qd
PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
4
PA-824 1200 mg/qd
PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
5
Rifafour e-275 mg
PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
Interventions
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PA-824
200 mg, 600 mg, 100 mg, 1200 mg qd
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* M/F 18-64 yo
* newly diagnosed pulmonary TB
* sputum positive
* adequate contraception
Exclusion Criteria
* 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
18 Years
64 Years
ALL
No
Sponsors
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Global Alliance for TB Drug Development
OTHER
Responsible Party
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Tiervlei Trial Center, University of Stellenbosch, South Africa
Principal Investigators
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Rodney Dawson, MD
Role: PRINCIPAL_INVESTIGATOR
UCT Lung Institute
Andreas Diacon, MD
Role: PRINCIPAL_INVESTIGATOR
Tiervlei Trial Center, Stelennbosch University, South Africa
Locations
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Tiervlei Trials Center, Stellenbosch University
Cape Town, Cape Province, South Africa
University of Cape Town Lung Institute
Cape Town, Cape Province, South Africa
Countries
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Related Links
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Related Info
Other Identifiers
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PA-824-CL-007
Identifier Type: -
Identifier Source: org_study_id
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