MedTrace Logo

Comparing Tigecycline Vs. Colistimethate in CNS Infections

NCT06702943 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2024-11-25

No results posted yet for this study

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.

Conditions

  • Central Nervous System Infections

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Eligibility

Min Age
28 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-10-31
Completion
2027-06-30
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06702943 on ClinicalTrials.gov