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Glossary
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Sponsors and Collaborators: |
Centers for Disease Control and Prevention University of KwaZulu Columbia University Yale University |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00664313 |
The antibiotic linezolid when given for the treatment of multi-drug resistant tuberculosis is safe and tolerated at a low dose (600 mg daily) for a limited duration (16 weeks)
Condition | Intervention | Phase |
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Multi-Drug Resistant Tuberculosis Extensively Drug Resistant Tuberculosis |
Drug: Linezolid Drug: Placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | TBTC Study 30: A Phase I/II Pilot Study for Evaluation of Low Dose, Once Daily, Linezolid Plus Optimized Background Therapy (OBT) Versus Placebo Plus OBT for the Treatment of Multi-Drug Resistant Tuberculosis |
Estimated Enrollment: | 64 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Linezolid 600 mg po QD
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Drug: Linezolid
600 mg po daily for 112 doses (16 weeks)
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo given daily for 112 doses (16 weeks)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Laboratory parameters done within 14 days prior to screening:
Exclusion Criteria
Contact: Nesri Padayatchi, MBChB | 27 31 2604574 | padayatchin@ukzn.ac.za |
South Africa | |
King George V Hospital | |
Durban, South Africa |
Principal Investigator: | Jussi Saukkonen, MD | Boston University |
Principal Investigator: | Waffa El-Sadr, MD | Columbia University |
Principal Investigator: | Nesri Padayachin, MBChB | University of Kwa-Zulu Natal |
Responsible Party: | Tuberculosis Trials Consortium, CDC ( William R. Mac Kenzie, MD, CDC TBTC Project Officer ) |
Study ID Numbers: | TBTC Study 30 |
Study First Received: | April 18, 2008 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00664313 History of Changes |
Health Authority: | United States: Food and Drug Administration; South Africa: Medicines Control Council |
Linezolid Zyvox Peripheral Neuropathy |
Optic Neuropathy Anemia Thrombocytopenia |
Bacterial Infections Anti-Infective Agents Tuberculosis, Multidrug-Resistant Anemia Gram-Positive Bacterial Infections Thrombocytopenia Optic Nerve Disorder |
Peripheral Nervous System Diseases Mycobacterium Infections Tuberculosis Extensively Drug-Resistant Tuberculosis Optic Nerve Diseases Linezolid |
Bacterial Infections Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Tuberculosis, Multidrug-Resistant Enzyme Inhibitors Actinomycetales Infections Pharmacologic Actions |
Protein Synthesis Inhibitors Gram-Positive Bacterial Infections Therapeutic Uses Mycobacterium Infections Tuberculosis Extensively Drug-Resistant Tuberculosis Linezolid |