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Population Pharmacokinetics of Antibiotics in Critically Ill Children (POPSICLE)

NCT03248349 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2020-03-13

No results posted yet for this study

Summary

Infections are common on the Intensive Care for both adult and pediatric patients. Adequately dosing antibiotic treatment is of vital importance but both under- and overdosing is frequent due to pathophysiological changes during critical illness. Moreover, the interplay of age and critical illness is even more understudied.

To optimize antibiotic dosing and outcome of infectious disease, personalized dosing guidelines in critically ill patients are highly needed. In this prospective observational population pharmacokinetic study we will evaluate if target attainment for antibiotics is reached in critically ill children with current dosing guidelines. Using these data, individualized dosing guidelines will be developed.

Conditions

Interventions

DRUG

Pharmacokinetics

* Blood samples are drawn for pharmacokinetic properties of antibiotics during routine care treatment * Blood samples for relevant covariates of drug disposition (kidney function, liver enzymes, C-reactive protein (CRP), albumin) * Whole blood is stored for DNA analysis * Urine is drawn from catheter for more detailed estimation of glomerular filtration rate and drug metabolite analysis

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Saskia N de Wildt, Prof. M.D. · Radboud University Medical Center

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2020-05-01
Completion
2020-10-01
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03248349 on ClinicalTrials.gov