Colistin Dosage Prsonalization Approach

NCT06472271 | Recruiting FDA Drug

• 1 other identifier: colistin in neonates
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Colistin Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Clinical response

  Resolving signs and symptoms with normalized acute phase reactants in clinical septic patients

  21 days

Secondary Outcomes (1)

• Microbiological clearance

  21 days

Study Arms (2)

Conventional initial dose

Colistin 5mg/kg/day

Drug: Polymyxin e

High initial dose

Colistin 7.5mg/kg/day

Drug: Polymyxin e

Interventions

Polymyxin e DRUG

Increased starting colistin dose

Also known as: Colistin

Conventional initial dose; High initial dose

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahmoud I Mostafa: lead

Study Sites (1)

Cairo univrsity Hospitals

Cairo, 11435, Egypt

RECRUITING

MeSH Terms

Interventions

Colistin

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 21 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer at pharmacy practice department

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: July 30, 2024
• Primary Completion: November 30, 2024
• Study Completion: October 30, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

EG (1)