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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02967341

Enrollment

Registered

2016-11-18

Start date

2016-03-31

Completion date

2017-03-31

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Cancer, Neutropenia

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.

Interventions

OTHERCiprofloxacin 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 17 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction	1 hour

Countries

Belgium

Contacts

Primary ContactKevin Meesters, MD MPH

kevin.meesters@uzbrussel.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026