Table 3. Currently open and registered clinical trials in tuberculous meningitis (from the ClinicalTrials.gov and ISRCTN registries).
Trial Name | Registration
Number |
Countries
Recruiting |
Target Patient Group | Study Arms | Primary Outcome | Sample
Size |
---|---|---|---|---|---|---|
Optimizing Anti-tuberculosis
Therapy in Adults with Tuberculous Meningitis |
NCT03787940 | China | Adults 18–65 years | Standard dose vs. high dose isoniazid for
rapid NAT2 acetylators |
Death or severe disability at 12
months from enrolment |
338 rapid
acetylators |
Retrospective Real-word
Study of Linezolid for the Treatment of Tuberculous Meningitis |
NCT03898635 | China | Adults 18 years and
older |
1. No linezolid in treatment regimen at
any point 2. Linezolid added during the treatment course 3. Linezolid in treatment regimen from beginning |
Survival within five years | n/s |
Linezolid, Aspirin and
Enhanced Dose Rifampicin in HIV-TBM (LASER-TBM) |
NCT03927313 | South Africa | HIV-infected adults
(>18 years) |
1. Standard of care drug regimen at
standard of care dosages 2. Higher dosages of rifampicin and the addition of linezolid for the first 56 days of treatment 3. Higher dosages of rifampicin and the addition of linezolid and aspirin for the first 56 days of treatment |
Treatment related adverse events | 100 |
Adjunctive Corticosteroids
for Tuberculous Meningitis in HIV-infected Adults (The ACT HIV Trial) |
NCT03092817 | Vietnam,
Indonesia |
HIV-infected adults
(>18 years) |
Dexamethasone vs. placebo | Survival 12 months post
randomisation |
520 |
Leukotriene A4 Hydrolase
Stratified Trial of Adjunctive Corticosteroids for HIV- uninfected Adults with Tuberculous Meningitis |
NCT03100786 | Vietnam | HIV-uninfected adults
(>18 years) |
1. Open label dexamethasone for all
patients with TT genotype for first 6–8 weeks treatment 2. Individuals with CT or CC genotypes randomised to dexamethasone or placebo for first 6–8 weeks treatment |
All-cause mortality or new
neurological event by 12 months post randomisation |
640 |
Optimizing Treatment to
Improve TBM Outcomes in Children (TBM-KIDS) |
NCT02958709 | India,
Malawi |
Children | 1. High dose rifampicin in a standard
drug regimen 2. High dose rifampicin and levofloxacin instead of ethambutol 3. Standard dose rifampicin in a standard drug regimen |
Characterise the pharmacokinetic
parameters of rifampicin and levofloxacin and describe outcomes and safety |
120 |
Harvest trial - improving
outcomes from TB meningitis with high dose oral rifampicin |
ISRCTN15668391 | Uganda,
b/South Africa, Indonesia |
Adults (>18 years) | Standardly dosed regimen compared to a
standard drug regimen but with elevated rifampicin dosage |
Six-month survival | 500 |
SURE: Short intensive
treatment for children with tuberculous meningitis |
ISRCTN40829906 | India,
Uganda, Vietnam, Zambia, Zimbabwe |
Children under 15
years (and over 28 days) |
Factorial design:
• First randomisation: standard drug regimen vs. drug regimen with high dose rifampicin and substitution of ethambutol with levofloxacin • Second randomisation: aspirin vs. placebo |
First randomisation: all-cause
mortality by 48 weeks Second randomisation: neurodevelopment at 48 weeks assessed using a Modified Rankin Score |
400 |
Improving diagnosis and
treatment of HIV-associated Tuberculous meningitis |
ISRCTN42218549 | Uganda | Adults (>18 years) | 1. Intravenous 20mg/kg/day rifampicin
for two weeks (followed by oral rifampicin 35mg/kg/day for six weeks) 2. Oral 35mg/kg/day rifampicin for eight weeks 3. Standard of care oral rifampicin (~10mg/kg/day) for eight weeks |
Pharmacokinetic parameters and
safety composite endpoint |
60 |