Colistin Dosage Prsonalization Approach

Recruiting now

Conditions studied: Colistin Adverse Reaction

In brief

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

Key facts

Study ID

NCT06472271

Run by

Mahmoud I Mostafa

People needed

100

Starts

2024-07-30

Expected to finish

2025-10-30

Last updated by the study team

2025-08-13

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cairo univrsity Hospitals — Cairo, Egypt (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.