Adjunctive Linezolid for the Treatment of Tuberculous Meningitis (NCT04021121) | Clinical Trial Compass
CompletedPhase 2
Adjunctive Linezolid for the Treatment of Tuberculous Meningitis
Uganda40 participantsStarted 2021-05-05
Plain-language summary
This is a phase II randomized open-label trial of high versus standard dose rifampin (RIF) with or without linezolid (LZD) for the first 4 weeks of treatment for Tuberculosis Meningitis (TBM) at Masaka Regional Referral Hospital in Uganda. Initial randomization will be to high (35 mg/kg/day) versus standard (10 mg/kg/day) dose oral rifampin for the first 4 weeks of intensive therapy. Participants will then undergo a second randomization to linezolid 1200 mg daily versus no linezolid for the first 4 weeks of therapy. The primary aims are (1) to determine the cerebrospinal fluid and plasma pharmacokinetics of adjunctive LZD 1200 mg daily in TBM patients receiving high or standard dose RIF and (2) to evaluate the tolerability of a 4-week course of LZD in TBM patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \> 18 years
✓. Written informed consent from participant or proxy
✓. Definite, probable, possible, or suspected TBM diagnosis wherein the patient is being committed to a full course of anti-TB treatment for TBM in the setting of routine care.
Exclusion criteria
✕. \>5 doses of TB treatment received within previous 5 days
✕. Discontinued TB treatment in prior 14 days
✕. Known current/previous drug resistant TB infection
✕. Known allergy to RIF, INH, PZA, EMB, LZD
✕. Previous treatment of TB or TBM with LZD
✕. Concomitant or planned use of monoamine oxidase inhibitors, selective serotonin reuptake inhibitors, HIV protease inhibitors, or any other drug with significant interaction with RIF, LZD, or any TB drugs (see Appendices C and D)
. Women who are pregnant or breastfeeding, or women or men of reproductive potential who are unwilling to use at least one reliable form of barrier contraception or to abstain from sexual activity while receiving study drug treatment and for 30 days after stopping study treatment. Acceptable forms of contraception include: condoms (male or female) with or without a spermicidal agent, or diaphragm or cervical cap with spermicide. Hormonal contraception is not recommended as it may be ineffective due to induction of metabolism when receiving rifampicin.
✕. Unwillingness to be an inpatient for 2 weeks for initial treatment or to attend follow up clinic visits