Health Condition 1: G01- Meningitis in bacterial diseases classified elsewhere
Conditions
Interventions
Intervention1: 4 drug ATT regimen for 6 months and high dose aspirin(8 weeks): once daily for six months: isoniazid (INH) 20mg/kg
rifampicin (RMP) 30mg/kg
pyrazinamide (PZA) 40mg/kg and
levofloxacin (LFX) 20mg/kg
Aspirinonce daily for 8 weeks (20mg/kg/day)
Control Intervention1: conventional ATT: 2 MONTHS INTENSIVE PHASE ATT followed by 10 months of con
Sponsors
university college londonUCL
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age:between29daysand 2.Weight:ââ?°Â¥3kg Symptoms compatible with TBM (e.g.fever, vomiting, anorexia, listlessness,headache. 3.CSFresult with abnormalities compatible with TBM(elevated cell count and/or protein with or withoutM.tuberculosisdetected by microscopy or GeneXpert).Physician believes thechild needs immediate initiation of anti-TB drugs. 4.Known (or pending confirmation of) HIV status 5.Parent/legalcarer give informed,written consent 6.Agree for aCSF sampleto be collected andprocessed for chemistry, microscopy,Ziehlââ?¬â?? Nielsenor auramine stain andmycobacterialculture(in process)and,where available,Xpert (GeneXpert/Rif or Xpert Ultra)prior to commencingtreatmentor when clinically stable todo so. Where patients have already been started on ATT, pre-screening CSF resultsshould beavailable . 7.Participantââ?¬•s carer/parentcan comply with the protocol requirements in the opinion of the site investigator 8.Homeaddress accessible for visiting and intending to remain within the recruitment area for follow upperiod ofat least18months
Exclusion criteria
Exclusion criteria: 1.Recent contact(last 12 months)withknown or suspectedrifampicin-resistant TB 2.Proven drugresistance to rifampicin in the child 3.On ATT for >7 days 4.Severely moribund; high risk of death within 24hours 5.History or presence of known allergy or other contraindication toany first-line anti- tuberculosisdrugs, corticosteroids, or aspirin 6.Pregnancy 7.History ofgastrointestinal (GI)bleeding or bleeding diathesis 8.Activeclinicalinfection with influenza or varicella 9.Grade 4 liver toxicity or other contraindicationsfor taking part in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALL CAUSE MORTALITY AND MODIFIED RANKIN SCORE MEASURING NEURODEVELOPMENTTimepoint: 48 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)MRS outcomes 2) All-cause mortality 3) Clinical or microbiological relapse of TBM and / or TB disease atSURE Protocol 4) Any new grade 3 or 4 clinical or laboratory adverse events and adverse events (any grade) leading to treatment modification 5) Other specific adverse events: a) Any gastro-intestinal bleeding(any grade) b) Drug-induced liver injury (DILI)of Grade 2 or more c) Development of obstructive hydrocephalusTimepoint: 24, 48 and 72 weeks | — |
Countries
India, Uganda, Viet Nam, Zambia, Zimbabwe
Contacts
Public ContactVarinder SinghSite PI LHMC
PGIMER Chandigarh
Outcome results
None listed