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Cipro-onco-validation.

Validation of central venous (Port A Cath®) blood draws for ciprofloxacin pharmacokinetic research in patients under treatment for childhood cancer. - Cipro-onco-validation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-004251-47-BE
Enrollment
15
Registered
2015-10-12
Start date
Unknown
Completion date
Unknown
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood cancer

Interventions

Trade Name: Ciprofloxacine 100mg/5mL oplossing voor infusie Product Name: ciprofloxacine Pharmaceutical Form: Solution for infusion

Sponsors

UZ Brussel
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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 intravenous for selective bowel decontamination as part of regular treatment • have a PAC (port a cath) for intravenous medication and blood draws. Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 (port a cath).

Design outcomes

Primary

MeasureTime frame
Main Objective: Investigating the agreement of ciprofloxacin concentrations between blood drawn via a central venous device (Port A Cath) versus via capillary sampling in pediatric cancer patients.;Secondary Objective: Not applicable.;Primary end point(s): Correlation per participant for ciprofloxacin concentrations drawn via PAC (port a cath) and via capillary sampling.;Timepoint(s) of evaluation of this end point: Concomittant blood draws.

Secondary

MeasureTime frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: None

Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University Hospital

bimetra.clinics@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026