Colistin Dosage Prsonalization Approach

Recruiting

• Conditions: Colistin Adverse Reaction
• Interventions: Drug: Polymyxin e

• Registration Number: NCT06472271
• Lead Sponsor: Mahmoud I Mostafa

Brief 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

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-18
• Last Update Submitted: 2024-06-18
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Study Start: 2024-07-30
• Primary Completion: 2024-11-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Neonates aged between (0-30 days) born before 37 weeks
• Critically ill patients with nosocomial infection with proven culture-resistant gram-negative bacteria.
• Neonates who are indicated for colistin and started colistin therapy for at least 48 hr.

Exclusion Criteria

• Serum creatinine ≥1.5 baseline before colistin
• Received colistin before NICU stay
• Administration of concurrent nephrotoxic drugs including amphotericin, gentamicin, or amikacin.
• Major congenital anomalies or with previous renal impairment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High initial dose	Polymyxin e	Colistin 7.5mg/kg/day
Conventional initial dose	Polymyxin e	Colistin 5mg/kg/day

Primary Outcome Measures

Name	Time	Method
Clinical response	21 days	Resolving signs and symptoms with normalized acute phase reactants in clinical septic patients

Secondary Outcome Measures

Name	Time	Method
Microbiological clearance	21 days	Negative culture results following Colistin therapy

Trial Locations

Locations (1)

Cairo univrsity Hospitals; 🇪🇬 Cairo, Egypt