Colistin Dosage Prsonalization Approach

Mahmoud I Mostafa

Status

Enrolling

Conditions

Colistin Adverse Reaction

Treatments

Drug: Polymyxin e

Study type

Observational

Funder types

Other

Identifiers

NCT06472271

colistin in neonates

Details and patient eligibility

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

Full 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

Enrollment

100 estimated patients

Sex

All

Ages

Under 28 days old

Volunteers

No Healthy Volunteers

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.