SURE â?? Short intensified treatment for children with tuberculousmeningitis

Phase 4

• Conditions: Health Condition 1: G01- Meningitis in bacterial diseases classified elsewhere

• Registration Number: CTRI/2020/02/023317
• Lead Sponsor: university college londonUC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified