Antibiotic Dosing Calculator for Neonates and Children Trial

A study in premature and full term neonates and children using non-blinded randomized intervention to compare a standard protocol dose versus dose calculator predicted dose of either vancomycin, amikacin or gentamicin with outcome measured by closeness to target concentration

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610001038088

Enrollment

Registered

2010-11-25

Start date

2011-04-25

Completion date

2012-08-28

Last updated

2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Test of a pharmacokinetically guided dose calculator for dosing of vancomycin, gentamicin or amikacin in premature neonates, neonates and infants

Interventions

A comparison will be made of standard of care protocol dose method with a web based pharmacokinetic model based dose calculator. The dose calculator uses primarily weight, post-menstrual age and serum creatinine. Additional factors include use of mechanical ventilation, inotropes and non-steroidal anti-inflammatory drugs. It is used to predict the initial dosing of vancomycin, amikacin or gentamicin. The intervention is applied once when initial dosing is decided by the clinician.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 2 Years

Healthy volunteers

Inclusion criteria

requires treatment with either vancomycin, gentamicin or amikacin

Exclusion criteria

None

Outcome results