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

Sponsored by:	Global Alliance for TB Drug Development
Information provided by:	Global Alliance for TB Drug Development
ClinicalTrials.gov Identifier:	NCT00567840

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 II

MedlinePlus related topics: Tuberculosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Experimental PA-824 200 mg/qd	Drug: PA-824 200 mg, 600 mg, 100 mg, 1200 mg qd
2: Experimental PA-824 600 mg/qd	Drug: PA-824 200 mg, 600 mg, 100 mg, 1200 mg qd
3: Experimental PA-824 1000 mg/qd	Drug: PA-824 200 mg, 600 mg, 100 mg, 1200 mg qd
4: Experimental PA-824 1200 mg/qd	Drug: PA-824 200 mg, 600 mg, 100 mg, 1200 mg qd
5: Active Comparator Rifafour e-275 mg	Drug: PA-824 200 mg, 600 mg, 100 mg, 1200 mg qd

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, Cape Province
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

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Tiervlei Trial Center, University of Stellenbosch, South Africa ( Prof. Andreas Diacon )
Study ID Numbers:	PA-824-CL-007
Study First Received:	December 4, 2007
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00567840
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

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Tuberculosis, pulmonary

Lung Diseases
Tuberculosis, Pulmonary
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:

Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009