CompletedPhase 4ACTRN12618000073202

Comparing two antibiotic regimens for the treatment of late onset sepsis in neonates

Cefazolin as an alternative to vancomycin for late onset sepsis in preterm infants; A randomised controlled pilot trial.

Sponsor

John Hunter Childrens Hospital

Enrollment

50 participants

Start Date

Apr 20, 2018

Study Type

Interventional

Conditions

Preterm Birth

Summary

About 25% of very preterm infants in the neonatal intensive care unit will develop a suspected infection, or late onset sepsis. Current empirical late onset sepsis treatment regimens usually include vancomycin, however this antibiotic is associated with the development of drug resistance. Antimicrobial resistance threatens the effective prevention and treatment of infections and is a serious threat to public health. Patients with infections caused by drug-resistant bacteria are at increased risk of worse clinical outcomes and consume more health resources. The aim of this study is to lead to the development of a safe and effective antibiotic regime for late onset sepsis in preterm infants using a randomised controlled trial design. Preterm infants <29 weeks with suspected late onset sepsis will be randomised to receive either a vancomycin or cephazolin containing antibiotic regimen, both of which should appropriately treat common bacterial causes of late onset sepsis. The trial results will potentially lead to reduced vancomycin use in Australasia and subsequently reduce the development of multi drug resistant organisms, and an overall reduction in health care costs.

Eligibility

Sex: Both males and femalesMin Age: 72 HourssMax Age: 16 Weekss

Inclusion Criteria4

Signed, written informed consent by a parent or a legal guardian
Infants <29 weeks gestation at birth
Baby starting treatment for an episode of suspected LOS
Postnatal age more than 72 hours and less than term corrected gestational age (at time of suspected LOS).

Exclusion Criteria2

Presence of major congenital malformation(s) or chromosomal abnormalities
Contraindications for either antibiotic regimen

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Interventions

The purpose of this study is to determine if it is possible in the trial setting to use an alternative narrow spectrum antibiotic combination (a more targeted approach) for late onset sepsis in premature infants. Treatment with the antibiotics Vancomycin and Gentamicin (standard care) or Cefazolin and Gentamicin (all intravenous administration). Cefazolin: Post natal age less than 8 days Weight: less than 2000g Dose: 25 mg/kg/dose Interval: 12 hourly Post natal age less than 8 days Weight: greater than or equal to 2000g Dose: 50 mg/kg/dose Interval:12 hourly Post natal age equal to or greater than 8 days Weight: less than 2000g Dose: 25 mg/kg/dose Interval: 8 hourly Post natal age equal to or greater than 8 days Weight:greater than or equal to 2000g Dose:50 mg/kg/dose Interval: 8 hourly Gentamicin Dose: 5mg/kg/dose Intervals Corrected Gestational Age/Postmenstrual Age -Less than 30+0 weeks 48 hourly -From 30+0-34+6 weeks 36 hourly - From 35+0 weeks 24 hourly Duration dependant on if sepsis is confirmed. If blood cultures are negative treatment will be for 48 hours. If sepsis confirmed infectious diseases advise will be sought. All medications are given as per National Neomed guidelines.