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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

June 3, 2008
August 15, 2012
April 2009
May 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00691392 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB)
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).

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).

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Multi-Drug Resistant Tuberculosis
  • Extensively Drug Resistant Tuberculosis
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
May 2010
May 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00691392
TBTC Study 30PK
Yes
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
  • University of Texas
  • Columbia University
  • University of KwaZulu
  • University of Cape Town
  • Boston University
  • Pfizer
Principal Investigator: Nesri Padayatchi, MBChB University of KwaZulu
Principal Investigator: Marc Weiner, MD The University of Texas at San Antonio
Centers for Disease Control and Prevention
August 2012

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