Pharmacokinetics and Pharmacodynamics of Ceftazidime in Pediatric ICU Patients

NCT03133910 | Unknown

• 1 other identifier: 2016-679
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Mortality benefit has been proven with early antibiotic administration in sepsis. Antimicrobial therapy should be based on early achievement of effective drug concentrations by optimizing the pharmacokinetic/pharmacodynamics of individual drugs. Optimal dosing in the critically ill patient can be challenging with the rapidly changing physiology of sepsis during the first days of hospitalization with capillary leak, fluid overload, changes in cardiac output, and alterations renal clearance. Ceftazidime is the preferred beta-lactam for empiric treatment of sepsis at Lurie Children's Hospital because of its anti-pseudomonal and anti-enteric bacilli coverage, however, the majority of pharmacokinetic data currently published in pediatrics does not include Intensive Care Unit (ICU) patients. Adult pharmacokinetic/pharmacodynamics data suggest that critically ill adults with high level of illness severity may benefit from continuous or extended infusion beta lactam therapy to optimize the therapeutic concentration particularly for pathogens that are relatively resistant to beta-lactams. Understanding the changing pharmacokinetic/pharmacodynamics of ceftazidime with the progression of illness in the ICU may help determine if current dosing regimens are adequate to maintain appropriate drug concentrations to optimize antimicrobial treatment.

Conditions

Sepsis

Keywords

Pharmacokinetics; Ceftazidime

Outcome Measures

Primary Outcomes (1)

• Duration of time that antibiotic concentration is above the minimum inhibitory concentration (T>MIC) of common gram negative bacteria

  Number of patients with altered ceftazidime concentrations due to critical illness as measured by less that 50% T\>MIC.

  Blood sample collection beings within 24 to 32 hours of antibiotics administration. Day 1 collections times are zero (predose); 30 minute post dose; 1 hour post dose; 4 hour post dose. Day 2 through 7 collections times occur 2 to 4 hour post dose.

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients between the ages of 2 months and 18 years admitted to the PICU/CICU who will receive ceftazidime for empiric or definitive antimicrobial therapy with an expected duration of greater than or equal to 48 hours.

You may qualify if:

• Admitted to pediatric or cardiac intensive care unit
• Between the ages of 2 month to 18 years
• Receiving ceftazidime for an anticipated course of greater than or equal to 48 hours
• Central venous or arterial access for blood sampling

You may not qualify if:

• Less than 2 months or greater than 18 years
• Anticipated need for renal replacement therapy or ECMO
• History of chronic kidney disease greater than stage 1
• Inadequate access for blood draws

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Northwestern Memorial Hospital: collaborator

Study Sites (1)

Ann & Robert H Lurie Childjren's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erin Bradley, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: April 28, 2017
• Study Start: March 9, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: April 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)