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Levofloxacin in treatment of tuberculosis infection of brain in children

Evaluation of efficacy of add on oral levofloxacin in children with tubercular meningitis aged 6 months-18 years: A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070282
Enrollment
102
Registered
2024-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A170- Tuberculous meningitis

Interventions

Intervention1: Levofloxacin add on to the intensive phase of standard anti tubercular therapy: Add on oral levofloxacin in a dose of 10 mg/kg/day (once daily in children older than 5 years and in two

Sponsors

All India Institute of Medical Sciences, Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed cases of tubercular meningitis presenting to Department of Pediatrics, All India Institute Medical Sciences, Rishikesh with a diagnosis of TB meningitis as per Marais’ criteria and parents willing to comply with the study protocol and follow up

Exclusion criteria

Exclusion criteria: Pre-existing major chronic systemic illness including cardiovascular (arrhythmia, prolonged QTc interval or history of any arrhythmia), respiratory (chronic lung disease), gastrointestinal system (chronic liver disease) or chronic renal disease

Design outcomes

Primary

MeasureTime frame
Functional Status ScaleTimepoint: 12 weeks

Secondary

MeasureTime frame
Childhood Behavioural Checklist internalizing, externalizing and total scoreTimepoint: 12 weeks;Duration of hospitalisationTimepoint: At diagnosis;Functional status scaleTimepoint: 12 weeks;Number of patients with paradoxical reactionTimepoint: within 12 weeks;Pediatric Cerebral Performance CategoryTimepoint: 12 weeks;Social quotient by Vineland Social Maturity ScaleTimepoint: 12 weeks;SurvivalTimepoint: 12 weeks

Countries

India

Contacts

Public ContactIndar Kumar Sharawat

All India Institute of Medical Sciences, Rishikesh

sherawatdrindar@gmail.com9560182301

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026