Evaluation of a new Dutch vancomycin dosage guideline in preterm and term neonates.

Evaluation of a new Dutch vancomycin dosage guideline in preterm and term neonates. - VancoNEO

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42496

Enrollment

Registered

2016-01-08

Start date

2016-03-15

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Antibiotic treatment

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - Treatment with vancomycin i.v. starting dose according to hospital guidelines (table 1) for a clinically suspected or proven infection - Signed informed consent from parents or legal guardians

Exclusion criteria

Exclusion criteria: - Parent refusal - Inability to monitor drug levels during treatment - Inability to sample blood

Design outcomes

Primary

Measure	Time frame
Main study parameter is the number of therapeutic first vancomycin trough levels, when receiving the earlier mentioned starting doses. Furthermore, the number of sub- and supra-therapeutic first trough levels will be determined as well.	—

Secondary

Measure	Time frame
Secondary study parameter is the determination of inter-patient variability in population pharmacokinetic parameters and drug exposure/MIC, expressed as AUC/MIC. Availability of these parameters will allow further improvement of the dosage regimens.	—

Countries

Netherlands

Outcome results