Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04152694
Other study ID # HP-00077498
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 9, 2018
Est. completion date September 1, 2020

Study information

Verified date March 2021
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dosing of ceftaroline in patients with chronic kidney disease is defined, but there is no data on pharmacokinetics and pharmacodynamics of the drug in patients receiving continuous renal replacement therapy (CRRT). The purpose of this study is to determine pharmacokinetics and pharmacodynamics of ceftaroline in a critically ill patient population receiving CRRT, in order to define a dosing recommendation in this population.


Description:

Ceftaroline fosamil is a time-dependent, hydrophilic, bactericidal fifth generation cephalosporin that was FDA approved in 2010 for community acquired pneumonia and skin and skin structure infections. Ceftaroline is FDA approved for both Gram-positive and Gram-negative organisms. Gram-positive organisms covered are Staphylococcus aureus (methicillin resistant and methicillin sensitive strains), Streptococcus agalactiae, Streptococcus pneumonia, and Streptococcus pyogenes. Gram-negative coverage includes Escherichia coli, Haemophilus influenza, Klebsiella pneumonia, and Klebsiella oxytoca. In order for ceftaroline to exhibit effective bacterial killing, it requires that a certain percentage of the dosing interval is spent above the MIC. Dosing of ceftaroline in patients with chronic kidney disease is defined, but there is no data on pharmacokinetics and pharmacodynamics of the drug in patients receiving continuous renal replacement therapy (CRRT). The purpose of this study is to determine pharmacokinetics and pharmacodynamics of ceftaroline in a critically ill patient population receiving CRRT, in order to define a dosing recommendation in this population. CRRT modes that patients may be receiving in this trial include: continuous veno-venous hemofiltration (CVVH), continuous veno-venous hemodialysis (CVVHD), and continuous veno-venous hemodiafiltration (CVVHDF).


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Admitted to an intensive care unit - Receiving CRRT (CVVH, CVVHDF, CVVHD) - Receiving ceftaroline Exclusion Criteria: - Pregnant patients - Burn patients - Patients with toxic epidermal necrolysis or Stevens-Johnson syndrome - Patients prescribed extended infusion ceftaroline

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ceftaroline levels in CRRT
Levels of ceftaroline measured in patients receiving CRRT

Locations

Country Name City State
United States University of Maryland Medical Center Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Half-life Ceftaroline elimination half-life 1 year
Primary Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Clearance Ceftaroline clearance 1 year
Primary Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Volume of distribution Ceftaroline volume of distribution 1 year
Primary Ceftaroline pharmacokinetics in critically ill patients receiving continuous renal replacement therapy - Sieving coefficient Continuous renal replacement therapy modality sieving coefficient for ceftaroline 1 year
Secondary Ceftaroline pharmacodynamics in patients receiving continuous renal replacement therapy Percentage of time ceftaroline levels are above the minimum inhibitory concentration for the most likely pathogen(s) 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05539521 - Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation Phase 2
Recruiting NCT04776486 - Iohexol Clearance in Critically Ill Patients With Augmented Renal Creatinine Clearance N/A
Completed NCT05766319 - The ICU-recover Box, Using Smart Technology for Monitoring Health Status After ICU Admission N/A
Recruiting NCT03231540 - The PREServation of MUScle Function in Critically Ill Patients (PRESMUS) N/A
Completed NCT02286869 - Cardioventilatory Coupling in Critically Ill Patients N/A
Completed NCT01434823 - 24 Hour Intensivist Coverage in the Medical Intensive Care Unit N/A
Active, not recruiting NCT01142570 - Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients N/A
Completed NCT01167595 - Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients N/A
Not yet recruiting NCT00916591 - Prokinetic Drugs and Enteral Nutrition N/A
Completed NCT01293708 - Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians:
Recruiting NCT00654797 - Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2 Phase 2
Withdrawn NCT00178321 - Improving Sleep in the Pediatric Intensive Care Unit N/A
Completed NCT01168128 - PERFormance Enhancement of the Canadian Nutrition Guidelines by a Tailored Implementation Strategy: The PERFECTIS Study N/A
Completed NCT02447692 - Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: The PROMIZING Study N/A
Recruiting NCT04582760 - Early Mobilization in Ventilated sEpsis & Acute Respiratory Failure Study N/A
Not yet recruiting NCT05961631 - Bio-electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation
Completed NCT03276650 - Admission of Adult-onset Still Disease Patients in the ICU
Completed NCT03922113 - Muscle Function After Intensive Care
Recruiting NCT05055830 - Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
Recruiting NCT06027008 - Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults N/A