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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 3, 2008

Last Updated Date

August 15, 2012

Start Date ^ICMJE

April 2009

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00691392 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB)

Official Title ^ICMJE

Linezolid Pharmacokinetics and Pharmacodynamics in the Treatment of Multi-Drug Resistant and Extensively-Drug Resistant Tuberculosis

Brief Summary

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).

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Multi-Drug Resistant Tuberculosis
Extensively Drug Resistant Tuberculosis

Intervention ^ICMJE

Drug: Linezolid
Linezolid 600 mg po daily for 16 weeks (112 doses) - over-encapsulated

Other Name: Zyvox
Drug: Microcrystalline Methylcellulose - Placebo
The placebo will be over-encapsulated microcrystalline methylcellulose

Other Name: Avicel

Study Arm (s)

Experimental: 1
Linezolid 600 mg po daily for 16 weeks (112 doses) given in addition to optimized background therapy for MDR TB

Intervention: Drug: Linezolid
Placebo Comparator: 2
Over-encapsulated microcrystalline methylcellulose (Avicel) - an inert filler

Intervention: Drug: Microcrystalline Methylcellulose - Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2010

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

South Africa

Administrative Information

NCT Number ^ICMJE

NCT00691392

Other Study ID Numbers ^ICMJE

TBTC Study 30PK

Has Data Monitoring Committee

Yes

Responsible Party

Centers for Disease Control and Prevention

Study Sponsor ^ICMJE

Centers for Disease Control and Prevention

Collaborators ^ICMJE

University of Texas
Columbia University
University of KwaZulu
University of Cape Town
Boston University
Pfizer

Investigators ^ICMJE

Principal Investigator:	Nesri Padayatchi, MBChB	University of KwaZulu
Principal Investigator:	Marc Weiner, MD	University of Texas San Antonio

Information Provided By

Centers for Disease Control and Prevention

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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