Population Pharmacokinetics of Antibiotics in Critically Ill Children (POPSICLE)

NCT03248349 | Unknown FDA Drug

• 1 other identifier: 2016-3085
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Critical Illness; Infectious Disease; Children

Keywords

Critically ill children; Pharmacokinetics; Anti-Bacterial agents

Outcome Measures

Primary Outcomes (2)

• Volume of distribution of antibiotics in critically ill children

  Population mean value of volume of distribution of antibiotics during critical illness. Mean population volume of distribution will be derived from pooled data of antibiotic concentrations. Covariates of influence on volume of distribution will be incorporated within a population pharmacokinetic model.

  14 days

• Clearance of antibiotics in critically ill children

  Population mean value of clearance of antibiotics during critical illness. Mean population clearance will be derived from pooled data of antibiotic concentrations. Covariates of influence on drug clearance will be incorporated within a population pharmacokinetic model.

  14 days

Study Arms (1)

1

Pharmacokinetics

Drug: Pharmacokinetics

Interventions

Pharmacokinetics DRUG

* 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

Also known as: Antibiotics

1

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill children receiving antibiotics.

You may qualify if:

• to 18 years of postnatal age;
• \>37 weeks of gestational age (in children less than 6 months of postnatal age);
• Admitted to pediatric intensive care unit;
• Indwelling central line or arterial line in place for clinical purposes, or regular blood work for clinical reasons;
• Antibiotic therapy already prescribed by treating physician;
• Written informed consent (IC).

You may not qualify if:

• Language or cognitive inability to understand written and oral informed consent.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

Related Publications (2)

• Hartman SJF, Upadhyay PJ, Mathot RAA, van der Flier M, Schreuder MF, Bruggemann RJ, Knibbe CA, de Wildt SN. Population pharmacokinetics of intravenous cefotaxime indicates that higher doses are required for critically ill children. J Antimicrob Chemother. 2022 May 29;77(6):1725-1732. doi: 10.1093/jac/dkac095.

  PMID: 35383374 DERIVED

• Hartman SJF, Upadhyay PJ, Hagedoorn NN, Mathot RAA, Moll HA, van der Flier M, Schreuder MF, Bruggemann RJ, Knibbe CA, de Wildt SN. Current Ceftriaxone Dose Recommendations are Adequate for Most Critically Ill Children: Results of a Population Pharmacokinetic Modeling and Simulation Study. Clin Pharmacokinet. 2021 Oct;60(10):1361-1372. doi: 10.1007/s40262-021-01035-9. Epub 2021 May 26.

  PMID: 34036552 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Blood plasma for antibiotic concentrations during admission (max. 14 days) * Whole blood sample for future DNA-analysis * Urine samples during admission (max. 14 days)

MeSH Terms

Conditions

Critical Illness; Communicable Diseases

Interventions

Pharmacokinetics; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Metabolism; Pharmacological and Toxicological Phenomena; Physiological Phenomena; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Saskia N de Wildt, Prof. M.D.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stan JF Hartman, M.D.

CONTACT

+31622739795; Stan.Hartman@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 14, 2017
• Study Start: May 24, 2017
• Primary Completion: May 1, 2020
• Study Completion: October 1, 2020
• Last Updated: March 13, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)