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Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients

NCT ID: NCT02967341

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Childhood Cancer Neutropenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ciprofloxacin administration

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

Group Type OTHER

Ciprofloxacin administration

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Ciprofloxacin Port A Cath (PAC)

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jutte van der Werff ten Bosch, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Brussel

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Kevin Meesters, MD MPH

Role: CONTACT

Email: [email protected]

Facility Contacts

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Jutte van der Werff ten Bosch, MD PhD

Role: primary

Kevin Meesters, MD MPH

Role: backup

Other Identifiers

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Safepedrug-02

Identifier Type: -

Identifier Source: org_study_id