Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB) (S30PK)

August 15, 2012 updated by: Centers for Disease Control and Prevention

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa
        • King George V Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Avicel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 month after the start of study therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
20 weeks after starting study therapy
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
one month after starting study therapy
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
16 weeks after starting study therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (ESTIMATE)

June 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2012

Last Update Submitted That Met QC Criteria

August 15, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBTC Study 30PK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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