Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients
Phase 4
- Conditions
- NeutropeniaChildhood Cancer
- Interventions
- Other: Ciprofloxacin administration
- Registration Number
- NCT02967341
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Children who
- are between 1 month and 18 years of age
- are under treatment for any type of childhood cancer
- use ciprofloxacin for prophylaxis of febrile neutropenia as part of regular treatment
- have a PAC for intravenous medication and blood draws.
Exclusion Criteria
Children will be excluded from this study if we are unable to
- obtain informed consent of both parents and assent of the child (if he/she is over 12 years of age)
- aspire blood from the PAC.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ciprofloxacin administration Ciprofloxacin administration Blood will be drawn, in all participants, via Port A Cath and via a peripheral draw.
- Primary Outcome Measures
Name Time Method Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction 1 hour
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universitair Ziekenhuis Brussel
🇧🇪Brussels, Belgium