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

Centers for Disease Control and Prevention (CDC)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multi-Drug Resistant Tuberculosis; Extensively Drug Resistant Tuberculosis

Treatments: Drug: Linezolid; Drug: Microcrystalline Methylcellulose - Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT00691392

TBTC Study 30PK

Details and patient eligibility

About

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).

Full 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).

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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

Treatment:

Drug: Linezolid

2

Placebo Comparator group

Description:

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

Treatment:

Drug: Microcrystalline Methylcellulose - Placebo