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

Phase 4

Active, not recruiting

• Conditions: Pyogenic Meningitis

• Registration Number: CTRI/2015/11/006360
• Lead Sponsor: Kolkata Medical College and Hospital

Brief Summary

This study is a randomised, double blind, parallel group single centre trial. It is an add-on study since both the group will receive the standard therapy.

the trial evaluates the efficacy of early dexamethasone therapy o.15mg/kg

/dose QDS for 4days before or along with antibiotic therapy in a case of pyogenic meningitis. the study is conducted in paediatric department of Kolkata medical college, west Bengal, India. The primary outcome measures will be mortality within 3weeks of treatment and secondary outcomes will be developement of seizure disorder at 3months and hearing impairment at 6 months after the disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-19
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 102

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

• 1Patient’s age less than 6 months or more than 12years.
• 2Where CSF analysis is not done or CSF profiles were not compatible with bacterial meningitis are to be excluded.
• 3Neonatal maninigitis .
• 4Patients received antibiotics outside before admission.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	3weeks

Secondary Outcome Measures

Name	Time	Method
Developement of seizure disorder	3months
Hearing impairment	6months

Trial Locations

Locations (1)

Kolkata Medical College and Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Kolkata Medical College and Hospital

🇮🇳Kolkata, WEST BENGAL, India

Nilay Ranjan Bagchi

Principal investigator

9433071198

nrbagchiped@gmail.com