Pilot Trial: Feasibility of Microdialysis for Pharmacokinetic Studies in Neonatal Patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020939-40-AT

Enrollment

Registered

2010-07-15

Start date

2010-07-28

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

The present pilot study intends to establish the logistics of MD measurements of antibiotics in subcutaneous tissue of neonatal intensive care patients. Antibiotic serum levels will be measured in parallel at certain time points to correlate these with MD measurements. The findings of the present study will help to establish and validate MD as a method for PK studies in paediatric patients.

Interventions

Trade Name: STANDACILLIN - Trockenstechampulle 1 g mit Loesungsmittel Product Name: STANDACILLIN - Trockenstechampulle 1 g mit Loesungsmittel Pharmaceutical Form: Powder and solvent for solution for i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male or female newborn babies born after 28 weeks post-gestational age (i.e. 28+0 weeks post-gestational age or older) • Clinical diagnosis of infection, requiring antibiotic therapy • Prescription of ampicillin, gentamicin or vancomycin for therapeutic reasons. • Signed informed consent by at least one parent or legal representative Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • HIV, Hepatitis B or C positive. • Major congenital malformations • Allergy or hypersensitivity against study drug. • Severe renal impairment, defined by a serum creatinine level > 1.6 mg/L • Severe thrombocytopenia <50.000/µl • Any disease considered a risk for proper performance of the study or risks to the patient, at the discretion of the investigator

Design outcomes

Primary

Measure	Time frame
Main Objective: - To establish the feasibility of continuous MD measurement of antibiotic concentrations in subcutaneous adipose tissue of neonatal intensive care patients. - To correlate subcutaneous MD measurements with serial serum antibiotic concentrations. Candidate antibiotics to be studied will be Ampicillin, Vancomycin and Gentamicin which are used frequently in our neonatal population ;Secondary Objective: -;Primary end point(s): Area under the concentration time curve (AUC), maximum concentration (Cmax), half-life (t1/2), time of maximum concentration (tmax).	—

Measure

Time frame

Main Objective: - To establish the feasibility of continuous MD measurement of antibiotic concentrations in subcutaneous adipose tissue of neonatal intensive care patients. - To correlate subcutaneous MD measurements with serial serum antibiotic concentrations. Candidate antibiotics to be studied will be Ampicillin, Vancomycin and Gentamicin which are used frequently in our neonatal population ;Secondary Objective: -;Primary end point(s): Area under the concentration time curve (AUC), maximum concentration (Cmax), half-life (t1/2), time of maximum concentration (tmax).

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026