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

Primary Purpose

Multi-Drug Resistant Tuberculosis, Extensively Drug Resistant Tuberculosis

Status
Completed
Phase
Phase 1
Locations
South Africa
Study Type
Interventional
Intervention
Linezolid
Microcrystalline Methylcellulose - Placebo
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multi-Drug Resistant Tuberculosis focused on measuring Multi-Drug Resistant Tuberculosis, Extensively Drug Resistant Tuberculosis, MDR TB, XDR TB, MDR, XDR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • King George V Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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

Over-encapsulated microcrystalline methylcellulose (Avicel) - an inert filler

Outcomes

Primary Outcome Measures

Characterize linezolid pharmacokinetic parameters (AUC0-24 and linezolid time over MIC) in patients with MDR-TB and XDR-TB.

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
characterize the pharmacokinetics of ofloxacin and potentially other second line anti-tuberculous drugs utilized in the treatment of patients with MDR TB.
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.

Full Information

First Posted
June 3, 2008
Last Updated
August 15, 2012
Sponsor
Centers for Disease Control and Prevention
Collaborators
University of Texas, Columbia University, University of KwaZulu, University of Cape Town, Boston University, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00691392
Brief Title
Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB)
Acronym
S30PK
Official Title
Linezolid Pharmacokinetics and Pharmacodynamics in the Treatment of Multi-Drug Resistant and Extensively-Drug Resistant Tuberculosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
University of Texas, Columbia University, University of KwaZulu, University of Cape Town, Boston University, Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multi-Drug Resistant Tuberculosis, Extensively Drug Resistant Tuberculosis
Keywords
Multi-Drug Resistant Tuberculosis, Extensively Drug Resistant Tuberculosis, MDR TB, XDR TB, MDR, XDR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Linezolid 600 mg po daily for 16 weeks (112 doses) given in addition to optimized background therapy for MDR TB
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Over-encapsulated microcrystalline methylcellulose (Avicel) - an inert filler
Intervention Type
Drug
Intervention Name(s)
Linezolid
Other Intervention Name(s)
Zyvox
Intervention Description
Linezolid 600 mg po daily for 16 weeks (112 doses) - over-encapsulated
Intervention Type
Drug
Intervention Name(s)
Microcrystalline Methylcellulose - Placebo
Other Intervention Name(s)
Avicel
Intervention Description
The placebo will be over-encapsulated microcrystalline methylcellulose
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesri Padayatchi, MBChB
Organizational Affiliation
University of KwaZulu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Weiner, MD
Organizational Affiliation
The University of Texas at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
King George V Hospital
City
Durban
State/Province
KwaZulu Natal
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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