Actively Recruiting

Age: 0Days - 28Days
All Genders
NCT06472271

Colistin Dosage Prsonalization Approach

Led by Mahmoud I Mostafa · Updated on 2025-08-13

100

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Colistin Dosage Prsonalization Approach

Who Can Participate

Age: 0Days - 28Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Neonates aged between 0 and 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 hours
Not Eligible

You will not qualify if you...

  • Serum creatinine ≥1.5 baseline before colistin treatment
  • Received colistin before neonatal intensive care unit stay
  • Administration of concurrent nephrotoxic drugs including amphotericin, gentamicin, or amikacin
  • Presence of major congenital anomalies or previous renal impairment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cairo univrsity Hospitals

Cairo, Egypt, 11435

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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