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A clinical trial to study the effect of a drug, named dexamethasone in infection of meninges

A study to assess the role of early dexamethasone therapy in prevention of morbidity and mortality in children aged 6months to 12 years with pyogenic meningitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/11/006360
Enrollment
102
Registered
2015-11-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Pyogenic Meningitis

Interventions

Intervention1: Dexamethasone: 0.15mg/kg/dose QDS for initial 4 days of antibiotic therapy. 1st dose of dexamethasone to be given 15 minutes before 1st dose of antibiotic Control Intervention1: Normal

Sponsors

Kolkata Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Any patient of 6 months to 12years of age with clinical manifestations of acute meningitis, CSF profile consistent with bacterial meningitis. 2. Confirmed pathogen by blood or CSF culture.

Exclusion criteria

Exclusion criteria: 1 Patientâ??s age less than 6 months or more than 12years. 2 Where CSF analysis is not done or CSF profiles were not compatible with bacterial meningitis are to be excluded. 3 Neonatal maninigitis . 4 Patients received antibiotics outside before admission. 5 CSF suggestive of viral, tubercular or fungal etiology. 6 any patient with a congenital or acquired abnormality of the central nervous system 7 a prosthetic device inserted into the central nervous system 8 previous episodes of bacterial meningitis 9 an underlying neurologic abnormality 10 a history of hypersensitivity to beta-lactam antibiotics are excluded

Design outcomes

Primary

MeasureTime frame
MortalityTimepoint: 3weeks

Secondary

MeasureTime frame
Developement of seizure disorderTimepoint: 3months;Hearing impairmentTimepoint: 6months

Countries

India

Contacts

Public ContactDebajyoti Datta

Medical college and hospital, kolkata

drdebajyotidatta.nrs@gmail.com9474487900

Outcome results

None listed

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