Leukotriene A4 Hydrolase Stratified Trial of Adjunctive Corticosteroids for HIV-uninfected Adults With Tuberculous Meningitis

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2024
• Main ID: NCT03100786
• Date of registration: 29/03/2017
• Prospective Registration: Yes
• Primary sponsor: Oxford University Clinical Research Unit, Vietnam
• Public title: Leukotriene A4 Hydrolase Stratified Trial of Adjunctive Corticosteroids for HIV-uninfected Adults With Tuberculous Meningitis
• Scientific title: A Randomized Double Blind Placebo Controlled Non-inferiority Trial of Adjunctive Dexamethasone for the Treatment of HIV-uninfected Adults With Tuberculous Meningitis Stratified by Leukotriene A4 Hydrolase Genotype
• Date of first enrolment: February 8, 2018
• Target sample size: 720
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03100786
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 3

Countries of recruitment

Vietnam

Contacts

• Name: Guy Thwaites, MD
• Affiliation: University of Oxford, UK

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult (18 years or older)

- HIV-uninfected

- Clinical diagnosis of TBM (=5 days of meningitis symptoms, and CSF abnormalities) and
anti-tuberculosis chemotherapy either planned or started by the attending physician

Note: Published diagnostic criteria will be applied to all enrolled participants at the end
of the study when all mycobacterial culture results are available. The criteria will
sub-divide all cases into definite, probable and possible TBM, and those with an
alternative diagnosis.

Exclusion Criteria:

- An additional brain infection (other than TBM) confirmed or suspected: positive CSF
Gram or India Ink stain; positive blood or CSF Cryptococcal antigen test

- More than 6 consecutive days of two or more drugs active against M. tuberculosis
immediately before screening

- More than 3 consecutive days of any type of orally or intravenously administered
corticosteroid immediately before randomisation

- Dexamethasone considered mandatory for any reason by the attending physician

- Dexamethasone considered to be contraindicated for any reason by the attending
physician

- Previously been randomised into the trial for a prior episode of TBM

- Lack of consent from the participant or family member (if the participant is
incapacitated by the disease)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis

Tuberculous Meningitis

Drug-Induced Liver Injury

Intervention(s)

Other: Placebo

Drug: Dexamethasone

Primary Outcome(s)

All-cause mortality or new neurological event [Time Frame: 12 months from randomisation]

Secondary Outcome(s)

Requirement for 'rescue' corticosteroids [Time Frame: during the 12 month follow-up]

Overall survival until 12 months after randomization [Time Frame: 12 months after randomization]

Neurological disability at 12 months (modified Rankin score) [Time Frame: at 12 months]

Severe (grade 3 and 4) and serious adverse events by 12 months [Time Frame: by 12 months]

Secondary ID(s)

27TB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam