Comparing Tigecycline Vs. Colistimethate in CNS Infections

NCT06702943 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: ACUC-FP-ASU#265
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Central nervous system infections; MDR bacteria

Outcome Measures

Primary Outcomes (2)

• 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.

  follow up of the patients from time of enrollment to end of treatment is for 14-21 days

• Clinical Cure rate

  Resolution of infection symptoms like fever, seizures, fatigue and neck stiffness.

  follow up of the patients from time of enrollment to end of treatment is for 14-21 days

Study Arms (1)

Pediatrics patients having EVD and suffering from meningitis caused by MDR bacteria

Drug: Tigecycline (Tygacil); Drug: Colistimethate sodium (CMS)

Interventions

Tigecycline (Tygacil) DRUG

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

Pediatrics patients having EVD and suffering from meningitis caused by MDR bacteria

Colistimethate sodium (CMS) DRUG

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

Pediatrics patients having EVD and suffering from meningitis caused by MDR bacteria

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Known allergy to tigecycline or colistimethate sodium. Patients with concurrent severe comorbid conditions that may confound study results.
• Neonates (less than 1 month old).

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Central Nervous System Infections

Interventions

Tigecycline; colistinmethanesulfonic acid

Condition Hierarchy (Ancestors)

Infections; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Abdelwahab, MSc

CONTACT

+20-1224959630; Nouran_elsherazy@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: November 25, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share