Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients

Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02967341
• Other study ID #: Safepedrug-02
• Status: Recruiting
• Phase: Phase 4
• First received: July 27, 2016
• Last updated: November 15, 2016
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: June 2016
• Source: Universitair Ziekenhuis Brussel
• Contact: Kevin Meesters, MD MPH
• Email: kevin.meesters[@]uzbrussel.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 17 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Cancer
• Neutropenia

Intervention

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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction		1 hour	No