A randomised trial of 6 months Intensified anti-tuberculosis and 2 months antiInflammatory treatment for HIV-Infected and HIV-uninfected African and Asianchildren with tuberculous meningitis: Sure Trial. - SURE

university college londonUC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Age:between29daysand <15 years
•2.Weight:>=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,Ziehlâ??
•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.Participantâ??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

•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

发起方

university college londonUC