Colistin Dosage Prsonalization Approach

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

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

Study Overview

• Status: Recruiting
• Conditions: Colistin Adverse Reaction
• Intervention / Treatment: Drug: Polymyxin e

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11435
    • Recruiting
    • Cairo univrsity Hospitals
    • Contact: Doaa Hamed, PHD; Phone Number: 01062963529; Email: doaa.labib@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Preterm, critically-ill, neonates diagnosed with resistant gram-negative infections

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Conventional initial dose; Colistin 5mg/kg/day	Drug: Polymyxin e; Increased starting colistin dose; Other Names: Colistin
High initial dose; Colistin 7.5mg/kg/day	Drug: Polymyxin e; Increased starting colistin dose; Other Names: Colistin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response	Resolving signs and symptoms with normalized acute phase reactants in clinical septic patients	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological clearance	Negative culture results following Colistin therapy	21 days

Collaborators and Investigators

• Sponsor: Mahmoud I Mostafa

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Colistin; Polymyxins
• Other Study ID Numbers: colistin in neonates

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No