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Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients

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ClinicalTrials.gov Identifier: NCT02967341
Recruitment Status : Unknown
Verified June 2016 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
First Posted : November 18, 2016
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

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.

Condition or disease Intervention/treatment Phase
Childhood Cancer Neutropenia Other: Ciprofloxacin administration Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validation of Central Venous (Port A Cath®) Blood Draws for Ciprofloxacin Pharmacokinetic Research in Patients Under Treatment for Childhood Cancer
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017


Arm Intervention/treatment
Ciprofloxacin administration
Blood will be drawn, in all participants, via Port A Cath and via a peripheral draw.
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.
Other Names:
  • Ciprofloxacin
  • Port A Cath (PAC)




Primary Outcome Measures :
  1. Correlation between ciprofloxacin concentration drawn via Port a Cath (PAC) versus capillary/venous punction [ Time Frame: 1 hour ]


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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967341


Contacts
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Contact: Kevin Meesters, MD MPH kevin.meesters@uzbrussel.be

Locations
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Belgium
Universitair Ziekenhuis Brussel Recruiting
Brussels, Belgium, 1090
Contact: Jutte van der Werff ten Bosch, MD PhD       Jutte.VanderWerffTenBosch@uzbrussel.be   
Contact: Kevin Meesters, MD MPH       kevin.meesters@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Jutte van der Werff ten Bosch, MD PhD Universitair Ziekenhuis Brussel

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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02967341     History of Changes
Other Study ID Numbers: Safepedrug-02
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors