|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Centers for Disease Control and Prevention |
|---|---|
| Collaborators: |
University of KwaZulu Columbia University Yale University |
| Information provided by: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00664313 |
Purpose
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 |
|---|---|---|
|
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: | April 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Linezolid 600 mg po QD
|
Drug: Linezolid
600 mg po daily for 112 doses (16 weeks)
|
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo given daily for 112 doses (16 weeks)
|
Eligibility| 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
Contacts and Locations| Contact: Nesri Padayatchi, MBChB | 27 31 2604574 | padayatchin@ukzn.ac.za |
| South Africa | |
| King George V Hospital | Recruiting |
| Durban, South Africa | |
| Contact: Nesri Padayachi, MBChB 27 31 2604574 padayatchin@ukzn.ac.za | |
| Principal Investigator: Nesri Padayatchin, MBChB | |
| 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 |
More Information
| 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: | January 6, 2010 |
| 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 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 |