Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB) (S30PK)
This study has been completed.
Sponsor:
Collaborators:
University of Texas
Columbia University
University of KwaZulu
University of Cape Town
Boston University
Pfizer
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00691392
First received: June 3, 2008
Last updated: August 15, 2012
Last verified: August 2012
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Purpose
This is a one-period, double-blind, single-center pharmacokinetic study of linezolid in patients with MDR or XDR tuberculosis treated with linezolid and an Optimized Background Therapy (defined as treatment with > 4 drugs with activity against tuberculosis to which the patient's isolate is believed to be sensitive by history or based on drug sensitivity testing).
| Condition | Intervention | Phase |
|---|---|---|
|
Multi-Drug Resistant Tuberculosis Extensively Drug Resistant Tuberculosis |
Drug: Linezolid Drug: Microcrystalline Methylcellulose - Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Linezolid Pharmacokinetics and Pharmacodynamics in the Treatment of Multi-Drug Resistant and Extensively-Drug Resistant Tuberculosis |
Resource links provided by NLM:
Further study details as provided by Centers for Disease Control and Prevention:
Primary Outcome Measures:
- Characterize linezolid pharmacokinetic parameters (AUC0-24 and linezolid time over MIC) in patients with MDR-TB and XDR-TB. [ Time Frame: 1 month after the start of study therapy ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess the pharmacodynamic effects of linezolid AUC0-24 on tolerability (bone marrow toxicity, peripheral and ocular neuropathies) and safety during four months of treatment of tuberculosis [ Time Frame: 20 weeks after starting study therapy ] [ Designated as safety issue: Yes ]
- characterize the pharmacokinetics of ofloxacin and potentially other second line anti-tuberculous drugs utilized in the treatment of patients with MDR TB. [ Time Frame: one month after starting study therapy ] [ Designated as safety issue: No ]
- Assess the pharmacodynamic effect of linezolid pharmacokinetic parameters ( on biomarkers of treatment activity. Biomarkers to be evaluated are time to detection in liquid culture, sputum culture conversion at two and four months of study treatment. [ Time Frame: 16 weeks after starting study therapy ] [ Designated as safety issue: No ]
| Enrollment: | 26 |
| Study Start Date: | April 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Linezolid 600 mg po daily for 16 weeks (112 doses) given in addition to optimized background therapy for MDR TB
|
Drug: Linezolid
Linezolid 600 mg po daily for 16 weeks (112 doses) - over-encapsulated
Other Name: Zyvox
|
|
Placebo Comparator: 2
Over-encapsulated microcrystalline methylcellulose (Avicel) - an inert filler
|
Drug: Microcrystalline Methylcellulose - Placebo
The placebo will be over-encapsulated microcrystalline methylcellulose
Other Name: Avicel
|
Detailed Description:
This is a one-period, double-blind, single-center pharmacokinetic study of linezolid in patients with MDR or XDR tuberculosis treated with linezolid and an Optimized Background Therapy (defined as treatment with > 4 drugs with activity against tuberculosis to which the patient's isolate is believed to be sensitive by history or based on drug sensitivity testing).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Enrolled in the TBTC Study 30
- Provision of informed consent for the study
Exclusion Criteria:
- Severe anemia as defined by a hematocrit less than 25% (most recent value, measured within 30 days of the PK study).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691392
Locations
| South Africa | |
| King George V Hospital | |
| Durban, KwaZulu Natal, South Africa | |
Sponsors and Collaborators
University of Texas
Columbia University
University of KwaZulu
University of Cape Town
Boston University
Pfizer
Investigators
| Principal Investigator: | Nesri Padayatchi, MBChB | University of KwaZulu |
| Principal Investigator: | Marc Weiner, MD | University of Texas San Antonio |
More Information
No publications provided
| Responsible Party: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00691392 History of Changes |
| Other Study ID Numbers: | TBTC Study 30PK |
| Study First Received: | June 3, 2008 |
| Last Updated: | August 15, 2012 |
| Health Authority: | United States: Food and Drug Administration South Africa: Medicines Control Council |
Keywords provided by Centers for Disease Control and Prevention:
|
Multi-Drug Resistant Tuberculosis Extensively Drug Resistant Tuberculosis MDR TB |
XDR TB MDR XDR |
Additional relevant MeSH terms:
|
Tuberculosis Tuberculosis, Multidrug-Resistant Extensively Drug-Resistant Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
Linezolid Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013