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. 2019 Nov 5;4:167. [Version 1] doi: 10.12688/wellcomeopenres.15535.1

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