PharmacoKinetic modelling for Antibiotics and Antifungals in Paediatric Patients on Life-saving therapies (Extracorporeal Therapies) - Phase 1 and 2

Not Applicable

Recruiting

• Conditions: Critical illness in children and infants; Sepsis in children and infants; Infection - Studies of infection and infectious agents; Public Health - Health service research

• Registration Number: ACTRN12621000606886
• Lead Sponsor: Queesland Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-20
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Patient will be recruited if they meet the inclusion criteria.
INCLUSION CRITERIA
Paediatrics from birth up to 18 years of age admitted to Paediatric Intensive Care Unit at the Queensland Children’s Hospital and the University Children's Hospital Zurich are eligible if ALL of the following criteria are met.
1. Consent to continue approach (consent will be sought with a followup of written or phone consent to be obtained from the parent or carer, within 24 hours of inclusion in the study.
2. Paediatric patients requiring extracorporeal therapies either extracorporeal membrane oxygenation and/or continuous renal replacement therapy.
3. Patients are prescribed one or more of the following antimicrobials: cefotaxime, meropenem, ampicillin, piperacillin/tazobactam, vancomycin, gentamicin, flucloxacillin, fluconazole, voriconazole, fluconazole, micafungin, anidulafungin, ceftazidime and teicoplanin.
4. Patients may receive multiple antimicrobials concurrently.
5. indwelling catheter

Exclusion Criteria

Patient will not be included if they meet the exclusion criteria
EXCLUSION CRITERIA
Patients are excluded from the study if ONE OR MORE of the following criteria are met:
1. No consent to continue
2. Known allergy to study antimicrobial
3. Pregnancy
4. Ongoing massive blood transfusion requirements (>50% blood volume transfused in the previous 8 hours) 5. Haemoglobin is less than 70 g/L
6. Therapeutic plasma exchange in the preceding 24 hours
7. No arterial or venous access for sampling

Study & Design

• Study Type: Observational
• Study Design: Not specified