An exploratory pharmacokinetics and pharmacodynamics study beta-lactam antibiotics in pediatric intensive care patients: is there a need for more precision?

Conditions: Infectious diseases

Registration Number: NL-OMON29496

Lead Sponsor: MRace

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

•Written informed consent has been obtained from the patient or their legally authorised representative
•Suitable intra-arterial access to facilitate sample collection
•Recruitment within 36 hours after start of antibiotic therapy
•Intravenous antibiotic therapy of the target antibiotic should be aimed for at least 2 days

Exclusion Criteria

•Consent not obtained
•Premature infants
•History of anaphylaxis for the study antibiotics
•Study antibiotic cessation before blood collection
•Prophylactic use of the study antibiotics

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main objective is to determine the prevalence of target attainment for six frequently used beta-lactam antibiotics in the early phase after start of the therapy in PICU patients. Target attainment for beta-lactam antibiotics is set at 100% of time (T) of the dosing interval in which the unbound (free, ƒ) serum antibiotic concentration remains above the above the epidemiological cut-off (ƒT > MICECOFF).

Secondary Outcome Measures

Name	Time	Method
To identify risk factors and clinical outcomes associated with target non-attainment. Factors likely to contribute to outcomes are analysed for association based on clinical relevancy and previously described relationship, and include: <br>•Length of PICU stay, days on antibiotics, microbiological cure, and other clinical outcomes in PICU patients<br>•Use of other antibiotics<br>•C-reactive protein (CRP), interleukin 6 (IL-6), and procalcitonin<br>•Antibiotic resistance development<br>•Serum albumin<br>•Estimated glomerular filtration rate (eGFR = 90 mL/min/1.73 m2)<br>•Presence of continuous renal replacement therapy (CRRT)<br>