Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02967341|
Recruitment Status : Unknown
Verified June 2016 by Universitair Ziekenhuis Brussel.
Recruitment status was: Recruiting
First Posted : November 18, 2016
Last Update Posted : November 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Childhood Cancer Neutropenia||Other: Ciprofloxacin administration||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of Central Venous (Port A Cath®) Blood Draws for Ciprofloxacin Pharmacokinetic Research in Patients Under Treatment for Childhood Cancer|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2017|
Blood will be drawn, in all participants, via Port A Cath and via a peripheral draw.
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.
- Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction [ Time Frame: 1 hour ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967341
|Contact: Kevin Meesters, MD MPHfirstname.lastname@example.org|
|Principal Investigator:||Jutte van der Werff ten Bosch, MD PhD||Universitair Ziekenhuis Brussel|