Recruiting

Gentamicin

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT07460349

Conditions

Early Onset Sepsis

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hours

Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hours

Study Details

Brief summary:

A previous pharmacy residency project was done 20 years ago looking at the best dosing for the antibiotic gentamicin for babies up to 7 days old. This study showed that giving the dose less often leads to better drug concentrations than giving the dose more often. Our gentamicin dosing at the Children's Hospital at London Health Sciences Centre is based on the better dosing from the study. This dosing is gentamicin 3 mg/kg every 24 hours for babies less than 35 weeks gestational age and 3.5 mg/kg every 24 hours for babies at least 35 weeks gestational age. These results were never published. Different dosing is used at different hospitals. It is important that we check that our gentamicin dosing is still reaching safe and effective drug concentrations in the current study. The study will look at the gentamicin drug concentrations of babies up to 7 days old, including premature and term babies. We will also confirm if the babies have kidney or hearing damage from gentamicin. We will compare the gentamicin drug concentrations from this study to the past data to see if the dosing is still the best. The results can help form a guideline for the Children's Hospital and surrounding hospitals.

Conditions

Early Onset Sepsis

Study ID

NCT07460349

Start date

Jun, 2026

Status verified date

Jun, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Neonates up to 7 days of age,
  • Neonate must be on gentamicin, and
  • Gentamicin trough and peak levels must be available for the third dose of gentamicin.

Exclusion Criteria:

  • Incorrect dose for weight (+/- 10% allowed to account for dose rounding)
  • Multiple levels from the same patient; only the first set of levels will be collected
  • Baseline renal dysfunction (e.g. congenital kidney disease)
  • On other nephrotoxic or ototoxic drugs concurrently with the first 3 days of gentamicin

Study Design

Enrollment

42 participants

Anticipated

Interventions and Outcome Measures

Arms

Neonates less than 35 weeks gestational age

Neonates at least 35 weeks gestational age

Interventions

Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hours

No interventions will be made to the neonates. Standard of care will be followed with empiric gentamicin and levels ordered for the neonates at the discretion of the medical team.

Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hours

No interventions will be made to the neonates. Standard of care will be followed with empiric gentamicin and levels ordered for the neonates at the discretion of the medical team.

Primary outcome measure

  • Trough gentamicin levels [ Time Frame: Day 3 of treatment: prior to the third gentamicin dose ]

Central Contacts and Locations

Central contacts

Sarah H.P. Vo, PharmD

519-685-8500sarah.vo@lhsc.on.ca

Locations

Children's Hospital: London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Venita Harris, BScPharm, PharmD

519-685-8500venita.harris@lhsc.on.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • gentamicin
  • extended interval dosing
  • neonates

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2026-06-09.