Blood Draw Validation for Ciprofloxacin Pharmacokinetic Research in Pediatric Cancer Patients

NCT02967341 | Unknown Phase 4 DMC

• 1 other identifier: Safepedrug-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Cancer; Neutropenia

Outcome Measures

Primary Outcomes (1)

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

  1 hour

Study Arms (1)

Ciprofloxacin administration

OTHER

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

Other: Ciprofloxacin administration

Interventions

Ciprofloxacin administration 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.

Also known as: Ciprofloxacin, Port A Cath (PAC)

Ciprofloxacin administration

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Neoplasms; Neutropenia

Interventions

Ciprofloxacin; Vascular Access Devices

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Catheters; Equipment and Supplies

Study Officials

• Jutte van der Werff ten Bosch, MD PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Meesters, MD MPH

CONTACT

kevin.meesters@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: November 18, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 18, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)