NCT02967341

Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients

Validation of Central Venous (Port A Cath®) Blood Draws for Ciprofloxacin Pharmacokinetic Research in Patients Under Treatment for Childhood Cancer

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The concentration of cipro will be determined using a validated high-performance liquid chromatographic (HPLC) method with fluorescence detection. Unbound concentration will be determined by adjusting the pH of the plasma samples to physiological pH (7.4) in a CO2 incubator, followed by ultrafiltration and extraction of ciprofloxacin from the ultrafiltrate (as described above) prior to injection onto the HPLC system.

Conditions

• Childhood Cancer
• Neutropenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-11-18
• Last updated: 2016-11-18

Locations

1 site across 1 country: Belgium