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NOT YET RECRUITING
NCT06702943

Comparing Tigecycline Vs. Colistimethate in CNS Infections

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

This observational study compares the efficacy and safety of tigecycline, an alternative antibiotic with broad-spectrum activity, versus the standard colistimethate sodium-based regimen in managing these infections in pediatric patients. Inclusion Criteria: Pediatric patients aged 1 month to 18 years. Presence of CNS infection symptoms such as fever, altered mental status, and positive cerebrospinal fluid (CSF) findings. EVD placement for managing CNS infections. Exclusion Criteria: Known allergy to tigecycline or colistimethate sodium. Patients with concurrent severe comorbid conditions that may confound study results. Neonates (less than 1 month old), pregnant, or breastfeeding patients. Outcome Measures: Primary Outcomes: Clinical cure (resolution of infection symptoms) and microbiological cure (sterilization of CSF cultures). Secondary Outcomes: Mortality rates and adverse drug events, such as nephrotoxicity, hepatotoxicity, chemical meningitis, or seizures.

Official title: Comparative Study of the Efficacy and Safety of Tigecycline Based Regimen Versus Colistimethate Sodium-based Regimen in Patients with Central Nervous System Bacterial Infections

Key Details

Gender

All

Age Range

28 Days - 18 Years

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2024-12-01

Completion Date

2027-06

Last Updated

2024-11-25

Healthy Volunteers

No

Interventions

DRUG

Tigecycline (Tygacil)

tigecycline-based regimen administered both intravenously (IV) and intraventricularly (IVT) for 14-21 days

DRUG

Colistimethate sodium (CMS)

Colistimethate sodium-based regimen (standard therapy for MDR infections) administered both IV and IVT for 14-21 days.