Colistin Dosage Prsonalization Approach
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Polymyxin e.
- Who it may be relevant to
- Registry conditions: Colistin Adverse Reaction. Basic parameters: 0 Days — 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Colistin in Neonatal ICU Patients With Gram Negative Resistant Infection: Dosage Personalization Approach
Overview
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
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
Interventions
- Drug Polymyxin e
Increased starting colistin dose
Primary outcome measures
- Clinical response [Time frame: 21 days]
Secondary outcome measures (1)
- Microbiological clearance [Time frame: 21 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Cairo univrsity Hospitals — Cairo
Identifiers
NCT: NCT06472271 · colistin in neonates