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

Multi-Drug Resistant Tuberculosis Clinical Trial

— S30PK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691392
• Other study ID #: TBTC Study 30PK
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 3, 2008
• Last updated: August 15, 2012
• Start date: April 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Extensively Drug Resistant Tuberculosis
• Extensively Drug-Resistant Tuberculosis
• Multi-Drug Resistant Tuberculosis
• Tuberculosis
• Tuberculosis, Multidrug-Resistant

Intervention

Drug:
• Linezolid
Linezolid 600 mg po daily for 16 weeks (112 doses) - over-encapsulated
• Microcrystalline Methylcellulose - Placebo
The placebo will be over-encapsulated microcrystalline methylcellulose

Locations

Country	Name	City	State
South Africa	King George V Hospital	Durban	KwaZulu Natal

Sponsors (7)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Boston University, Columbia University, Pfizer, University of Cape Town, University of KwaZulu, University of Texas

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize linezolid pharmacokinetic parameters (AUC0-24 and linezolid time over MIC) in patients with MDR-TB and XDR-TB.		1 month after the start of study therapy	No
Secondary	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		20 weeks after starting study therapy	Yes
Secondary	characterize the pharmacokinetics of ofloxacin and potentially other second line anti-tuberculous drugs utilized in the treatment of patients with MDR TB.		one month after starting study therapy	No
Secondary	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.		16 weeks after starting study therapy	No