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

NCT00691392

Last updated date
Study Location
King George V Hospital
Durban, KwaZulu Natal, , South Africa
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Multi-Drug Resistant Tuberculosis, Extensively Drug Resistant Tuberculosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Enrolled in the TBTC Study 30

- Provision of informed consent for the study

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Severe anemia as defined by a hematocrit less than 25% (most recent value, measured
within 30 days of the PK study).

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Multi-Drug Resistant Tuberculosis, Extensively Drug Resistant TuberculosisLinezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB)
NCT00691392
  1. Durban, KwaZulu Natal
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: July 16, 2010)
26
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2008)
50
Actual Study Completion Date  ICMJE May 2010
Actual 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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00691392
Other Study ID Numbers  ICMJE TBTC Study 30PK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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, MBChBUniversity of KwaZulu
Principal Investigator:Marc Weiner, MDThe University of Texas at San Antonio
PRS Account 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