NCT03100786CompletedPhase 3
Leukotriene A4 Hydrolase Stratified Trial of Adjunctive Corticosteroids for HIV-uninfected Adults With Tuberculous Meningitis
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
Source: ClinicalTrials.gov · Last updated 17 Jun 2025
Brief summary (registry, in English)
The primary objective is to determine whether Leukotriene A4 hydrolase (LTA4H) genotype, defined at randomisation, determines dexamethasone's clinical effectiveness when added to the first 6-8 weeks of anti-tuberculosis treatment of TBM. The investigators will conduct a LTA4H genotype stratified, parallel group, randomised, double blind, placebo-controlled multi-centre Phase III non-inferiority trial evaluating dexamethasone versus placebo for 6-8 weeks in addition to standard anti-tuberculosis drugs. The investigators will take a hybrid trial-design approach which assumes a modest harm of dexamethasone and aims to prove non-inferiority of placebo first but also allows claiming superiority of placebo in case dexamethasone causes substantial harm. Moreover, as it is possible that harm of dexamethasone only applies to the LTA4H CC genotype, the trial will allow dropping the CT group at an interim analysis but continue randomization of the CC group. In making this assessment the investigators not only determine whether dexamethasone influences survival and the incidence of new neurological events (the primary endpoint), but also whether it influences disability assessed by the modified Rankin score 12 months after the start of treatment. The secondary objective is to investigate alternative management strategies in a subset of patients who develop drug-induced liver injury that will enable the safe continuation of rifampicin and isoniazid therapy whenever possible.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 702 (actual)
- First submitted
- 29 Mar 2017
- Start date
- 12 Feb 2018
- Primary completion date
- 9 Mar 2023
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Diseases
- Tuberculosis
- NCT number
- NCT03100786
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 702
- From 12 Feb 2018 to the primary completion date, 9 Mar 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Lack of consent from the participant or family member (if the participant is incapacitated by the disease)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pham Ngoc Thach Hospital Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
| Hospital for Tropical Diseases Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
| Oxford University Clinical Research Unit Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.