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ID
Source
Brief title
Health condition
Infectious diseases
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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)
Background summary
Morbidity and mortality in critically ill patients with infection is a global health problem. Emerging evidence supports the importance of optimized antibiotic exposure in pediatric intensive care unit (PICU) patients, while evidence based antibiotic dosing in PICU patients in clinical practice is limited. Changes in pharmacokinetic (PK) parameters of antibiotics in subpopulations of critically ill patient have been defined in previous studies. However, there are no data from studies assessing whether the issues identified in a controlled research environment correspond to clinical practice. Assessment of pharmacodynamic target attainment is warranted to identify whether clinical outcomes for patients admitted to the PICU can be improved. We propose an exploratory pharmacokinetic and pharmacodynamic (PK/PD) study to analyse whether current antibiotic dosing regimens of frequently used beta lactam antibiotics achieve defined therapeutic target concentrations in PICU patients.
Study objective
Current antibiotic treatment with beta lactam do not meet pharmacodynamic targets in pediatric intensive care unit patients
Study design
Day 0 till 6: bioanalysis of bloodsamples for drug exposure (primary)
Week 1: data abstraction EPR (secondary)
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9326 |
| Other | METC EMC : MEC-2021-0173 |