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Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients

Primary Purpose

Childhood Cancer, Neutropenia

Status
Unknown status
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Ciprofloxacin administration
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Cancer

Eligibility Criteria

1 Month - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Universitair Ziekenhuis BrusselRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ciprofloxacin administration

Arm Description

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

Outcomes

Primary Outcome Measures

Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction

Secondary Outcome Measures

Full Information

First Posted
July 27, 2016
Last Updated
November 15, 2016
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT02967341
Brief Title
Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients
Official Title
Validation of Central Venous (Port A Cath®) Blood Draws for Ciprofloxacin Pharmacokinetic Research in Patients Under Treatment for Childhood Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Cancer, Neutropenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ciprofloxacin administration
Arm Type
Other
Arm Description
Blood will be drawn, in all participants, via Port A Cath and via a peripheral draw.
Intervention Type
Other
Intervention Name(s)
Ciprofloxacin administration
Other Intervention Name(s)
Ciprofloxacin, Port A Cath (PAC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Meesters, MD MPH
Email
kevin.meesters@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jutte van der Werff ten Bosch, MD PhD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jutte van der Werff ten Bosch, MD PhD
Email
Jutte.VanderWerffTenBosch@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Kevin Meesters, MD MPH
Email
kevin.meesters@uzbrussel.be

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients

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