Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients

Universitair Ziekenhuis Brussel

Status and phase: Unknown; Phase 4

Conditions: Neutropenia; Childhood Cancer

Treatments: Other: Ciprofloxacin administration

Study type: Interventional

Funder types: Other

Identifiers

NCT02967341

Safepedrug-02

Details and patient eligibility

About

To validate blood draws via a central venous catheter (Port A Cath ®) for pharmacokinetic studies of ciprofloxacin in patients under treatment for childhood cancer.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 1 month to 17 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Ciprofloxacin administration

Other group

Description:

Blood will be drawn, in all participants, via Port A Cath and via a peripheral draw.

Treatment:

Other: Ciprofloxacin administration