A 5384- A Phase II, Randomized, Open-Label Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents with Tuberculous Meningitis: Improved Management with Antimicrobial AGents Isoniazid rifampiciN LinEzolid for TBM (IMAGINE TBM) - A5384

IH DAIDS0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月29日

试验速览

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•Persons aged >=15 years
•Absence of HIV-1 infection, as documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit, within 30 days prior to study entry
•Documentation within 3 days prior to study entry of stage of disease using BMRC TBM grade:
•Grade I: Glasgow Coma Score 15, no focal neurological deficits
•Grade II: Glasgow Coma Score 11-14 or 15 with focal neurological deficits
•Grade III: Glasgow Coma Score <=10
•Participants with documentation of a positive pregnancy test will be consented using the consent form for pregnant participants
•Ability and willingness of participant or parent or legally authorized representative (for adolescents or participants unable to provide consent) to provide informed consent/assent
•Ability to comply with the protocol requirements in the opinion of the site investigator

•More than 14 cumulative days of first-line TB medications, including but not limited to INH, RIF, EMB, and PZA, received within 90 days prior to study entry
•Known current or previous drug resistant TB infection (i.e., resistance to one or more first-line TB medications, including but not limited to INH, RIF, EMB, LZD and PZA)
•Known allergy/sensitivity or any hypersensitivity to components of study TB drugs (INH, RIF, LZD, PZA, and EMB) or their formulation
•Expected concomitant use or use up to 21 days prior to study entry of monoamine oxidase inhibitors or selective serotonin reuptake inhibitors, or concomitant use of any other drug with significant interaction with the study drugs
•For participants with HIV and ART-naÃ¯ve, planned initiation of ART during the first 4 weeks after randomization
•Contraindication to LP at discretion of treating clinician (e.g., unequal pressures between intracranial compartments due to mass lesion, non-communicating hydrocephalus)
•Positive cryptococcal antigen, gram stain, bacterial culture, or other test result obtained from a CSF specimen collected within 21 days prior to entry as part of routine care indicating CNS infection with a pathogen other than Mtb (e.g., cryptococcal meningitis, bacterial meningitis).

发起方

IH DAIDS