Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients
NCT02967341 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2016-11-18
Summary
To validate blood draws via a central venous catheter (Port A Cath ®) for pharmacokinetic studies of ciprofloxacin in patients under treatment for childhood cancer.
Conditions
- Childhood Cancer
- Neutropenia
Interventions
- OTHER
-
Ciprofloxacin administration
Ciprofloxacin will be administered via the PAC directly followed by a NaCl 0.9% flush to wash the PAC. At least 1 hour afterwards 500 microliter of blood will be drawn via the PAC. Directly hereafter a blood draw of 500 microliter will be performed either via capillary blood sampling or via a venipuncture. If an anaesthesia is foreseen for another procedure (e.g. a lumbar puncture or an osseous punction), we will strive to perform the peripheral blood draw under anaesthesia.
Sponsors & Collaborators
-
Universitair Ziekenhuis Brussel
lead OTHER
Principal Investigators
-
Jutte van der Werff ten Bosch, MD PhD · Universitair Ziekenhuis Brussel
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Month
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-31
- Primary Completion
- 2017-03-31
- Completion
- 2017-03-31
Countries
- Belgium
Study Locations
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