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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29496

Enrollment

150

Registered

2021-03-08

Start date

2021-05-03

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Infectious diseases

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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: • Length of PICU stay, days on antibiotics, microbiological cure, and other clinical outcomes in PICU patients • Use of other antibiotics • C-reactive protein (CRP), interleukin 6 (IL-6), and procalcitonin • Antibiotic resistance development • Serum albumin • Estimated glomerular filtration rate (eGFR = 90 mL/min/1.73 m2) • Presence of continuous renal replacement therapy (CRRT)	—

Measure

Time frame

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: • Length of PICU stay, days on antibiotics, microbiological cure, and other clinical outcomes in PICU patients • Use of other antibiotics • C-reactive protein (CRP), interleukin 6 (IL-6), and procalcitonin • Antibiotic resistance development • Serum albumin • Estimated glomerular filtration rate (eGFR = 90 mL/min/1.73 m2) • Presence of continuous renal replacement therapy (CRRT)

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Contacts

Public ContactStef Schouwenburg

Erasmus Medisch Centrum

s.schouwenburg@erasmusmc.nl010-703320

Outcome results