Colistin Dosage Prsonalization Approach

August 8, 2025 updated by: Mahmoud I Mostafa

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11435
        • Recruiting
        • Cairo univrsity Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 21 days
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
Time Frame: 21 days
Negative culture results following Colistin therapy
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahmoud I Mostafa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Actual)

November 30, 2024

Study Completion (Estimated)

October 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)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 8, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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