NCT06472271

Colistin Dosage Prsonalization Approach

Colistin in Neonatal ICU Patients With Gram Negative Resistant Infection: Dosage Personalization Approach

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Mahmoud I Mostafa · Academic / Other
• Sex: All
• Age: 0 Days – 28 Days
• Healthy volunteers: Not accepted

Summary

A few studies have evaluated higher doses or the administration or a loading dose, which is routine in adults, in pediatric patients, and reported improved colistin exposure without an increased risk of nephrotoxicity The main questions it aims to answer are What is the optimal dosing strategies of intravenous colistin for the treatment of multidrug-resistant gram-negative bacterial infections in preterm neonates? What is the incidence of AKI? What is the factors increasing AKI incidence? A single center retrospective and comparative study, cohort study compare low dose 5 mg/kg/day versus 7.5mg/kg/day

Detailed description

Retrospective study to measure safety and efficacy of colistin conventional dose versus high dose then prospective design to measure pharmacokinetics parameter of both doses to design optimal dose

Conditions

• Colistin Adverse Reaction

Interventions

Type	Name	Description
DRUG	Polymyxin e	Increased starting colistin dose

Timeline

• Start date: 2024-07-30
• Primary completion: 2024-11-30
• Completion: 2025-10-30
• First posted: 2024-06-25
• Last updated: 2025-08-13

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study