Clinical Trials Logo
  1. Home
  2. Pharmacokinetics
  3. NCT02456974
  4. Details
NCT02456974 Clinical Trial

Antibiotic Dosing in Pediatric Intensive Care

Pharmacokinetics Clinical Trial

— ADIC  

Official title:
Antibiotic Dosing in Pediatric Intensive Care

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02456974
Other study ID # 2012/172
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2012
Est. completion date April 28, 2025

Study information
Verified date December 2023
Source University Hospital, Ghent
Contact Pieter De Cock, PharmD
Phone +32 9 332 29 69
Email pieter.decock@uzgent.be
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Pharmacokinetics of antibiotics in critically ill neonates, infants and children

Recruitment information / eligibility
Status Recruiting
Enrollment 640
Est. completion date April 28, 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 1 Day to 16 Years
Eligibility Inclusion Criteria: - patients admitted to the pediatric intensive care unit - patient age/weight : 1,8 kg-15 years - patient receiving antibiotic treatment (piperacillin-tazobactam, amoxicillin-clavulanate, vancomycin, teicoplanin, meropenem, ciprofloxacin, amikacin) via intermittent infusion regimen or continuous infusion according to institutional treatment guidelines - intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred) Exclusion Criteria: - no catheter in place for blood sampling - absence of parental/patient consent - known hypersensitivity to beta-lactam antibiotics, glycopeptides, fluoroquinolones, aminoglycosides - extracorporeal circuit (haemodialysis, ECMO, peritoneal dialysis )

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care

• blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care.

• blood sampling in patients receiving vancomycin as part of routine clinical care.

• blood sampling in patients receiving teicoplanin as part of routine clinical care.

• blood sampling in patients receiving meropenem as part of routine clinical care.

• blood sampling and urine smapling in patients receiving ciprofloxacin as part of routine clinical care.

• blood sampling in patients receiving amikacin as part of routine clinical care.

Locations
Country Name City State
Belgium Ghent University Hospital, Hospital Pharmacy Ghent

Sponsors (3)
Lead Sponsor Collaborator
University Hospital, Ghent Queen Fabiola Children's University Hospital, Brussels, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary To investigate if first-dose blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens. 2 years (expected)
Primary To investigate if steady-state blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens. 2 years (expected)
Secondary To compare measured first-dose blood concentrations with predefined pharmacodynamic targets (Time above MIC) 2 years (expected)
Secondary To compare measured steady-state blood concentrations with predefined pharmacodynamic targets (Time above MIC) 2 years (expected)
See also
  Status Clinical Trial Phase
Completed NCT04092725 - Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects Phase 1
Completed NCT04181008 - Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers Early Phase 1
Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed NCT04406415 - Oral Nafamostat in Healthy Volunteers Phase 1
Not yet recruiting NCT05421312 - Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip Phase 4
Completed NCT02534753 - A Pharmacokinetics Study of Intravenous Ascorbic Acid Phase 1
Completed NCT01976078 - Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents N/A
Completed NCT01682408 - Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability Phase 1
Completed NCT01636024 - To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594 Phase 1
Completed NCT01415102 - A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372. Phase 1
Completed NCT01214941 - Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol Phase 4
Completed NCT01208155 - Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets Phase 1
Completed NCT01260025 - Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor Phase 1
Completed NCT00856570 - A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects Phase 1
Completed NCT00746499 - Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women. Phase 1
Completed NCT00984009 - A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice Phase 1
Completed NCT00730145 - A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis Phase 1
Completed NCT00747721 - Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU Phase 1
Completed NCT00983242 - Drug-Drug Interaction Between Colchicine and Verapamil ER Phase 1
Completed NCT01055964 - a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients Phase 3