Personalizing colistin dosage for preterm neonates
Colistin in Neonatal ICU Patients With Gram Negative Resistant Infection: Dosage Personalization Approach
Helwan University · NCT06472271
This study is testing whether a higher dose of colistin can safely treat serious infections in preterm babies better than a lower dose while trying to avoid kidney problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | Helwan University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06472271 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the optimal intravenous colistin dosing strategies for treating multidrug-resistant gram-negative infections in preterm neonates. It will compare the safety and efficacy of a conventional low dose of 5 mg/kg/day versus a higher dose of 7.5 mg/kg/day. The study will involve a retrospective analysis followed by a prospective design to assess pharmacokinetics and identify factors influencing acute kidney injury (AKI) incidence. The goal is to improve colistin exposure while minimizing nephrotoxicity risks.
Who should consider this trial
Good fit: Ideal candidates include critically ill neonates aged 0-30 days, born before 37 weeks, with nosocomial infections caused by culture-resistant gram-negative bacteria.
Not a fit: Patients with pre-existing renal impairment or those receiving concurrent nephrotoxic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective colistin dosing strategies for vulnerable preterm neonates.
How similar studies have performed: Previous studies have shown promising results with higher colistin doses in adults, but this specific approach in neonates is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Cairo univrsity Hospitals — Cairo, Egypt (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colistin Adverse Reaction