Cairo univrsity Hospitals
Cairo, 11435, Egypt
Location status: Recruiting
Recruiting
NCT Number: NCT06472271
Colistin Dosage Prsonalization 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
Recruiting
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Conditions
Age range
0 day–28 day
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Polymyxin e
DrugIncreased starting colistin dose
Other names: Colistin
Primary outcomes
-
Clinical response
Time frame: 21 days
Resolving signs and symptoms with normalized acute phase reactants in clinical septic patients
Secondary outcomes
-
Microbiological clearance
Time frame: 21 days
Negative culture results following Colistin therapy
Sponsors and collaborators
Lead sponsor
Mahmoud I Mostafa
Other
Registry information
Official study title
Colistin in Neonatal ICU Patients With Gram Negative Resistant Infection: Dosage Personalization Approach
Important dates
- Study start
- 2024
- Primary completion
- 2024
- Study completion
- 2025
- First posted
- Jun 25, 2024
- Registry last updated
- Aug 13, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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