Comparing Tigecycline Vs. Colistimethate in CNS Infections
ConditionCentral Nervous System Infections
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age28-18
SponsorAin Shams University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known allergy to tigecycline or colistimethate sodium. Patients with concurrent severe comorbid conditions that may confound study results.
Trial population
A total of 70 pediatric patients, aged 1 month to 18 years, admitted with confirmed or suspected CNS infections and with an external ventricular drain (EVD) in place.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tigecycline (Tygacil)
Drugtigecycline-based regimen administered both intravenously (IV) and intraventricularly (IVT) for 14-21 days
Colistimethate sodium (CMS)
DrugColistimethate sodium-based regimen (standard therapy for MDR infections) administered both IV and IVT for 14-21 days.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Pediatrics patients having EVD and suffering from meningitis caused by MDR bacteria2 interventions
Trial outcomes
Primary outcomes
1
Microbiological eradication
CSF Culture: Conducted at diagnosis and follow up for it till the end of the treatment course to monitor microbiological clearance. Two consecutive negative cultures are required to consider positive microbiological eradication.
Time frame
follow up of the patients from time of enrollment to end of treatment is for 14-21 days2
Clinical Cure rate
Resolution of infection symptoms like fever, seizures, fatigue and neck stiffness.
Time frame
follow up of the patients from time of enrollment to end of treatment is for 14-21 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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