Modelling of saliva amikacin and flucloxacillin concentrations in neonates receiving amikacin and flucloxacillin treatment

Modelling of saliva amikacin and flucloxacillin concentrations in neonates receiving amikacin and flucloxacillin treatment - Saliva amikacin and flucloxacillin concentrations in neonates

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55002

Enrollment

Registered

2020-05-22

Start date

2020-10-23

Completion date

Unknown

Last updated

2024-08-19

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

Inclusion criteria

Inclusion criteria: 1. Treatment with amikacin and flucloxacillin i.v. 2. Signed informed consent from both parents or legal guardians, according to local law and regulations 3. Admission to the neonatology ward, pediatrics/pediatric surgery department, obstetrics department or maternity ward of the AMC

Exclusion criteria

Exclusion criteria: 1. Congenital disease of the salivary glands 2. Parent refusal 3. Inability to sample saliva 4. Inability to sample blood or monitor drug levels during treatment

Design outcomes

Primary

Measure	Time frame
The concentration-time profile of saliva and plasma amikacin and flucloxacillin levels in neonates.	—

Secondary

Measure	Time frame
The saliva-plasma ratio amikacin and flucloxacillin, pharmacokinetic parameters, such as clearance (CL) and volume of distribution (Vd) will be estimated from the data during model building, identification of covariates.	—

Countries

Netherlands

Outcome results