Cipro-onco-validation.
Phase 1
- Conditions
- Childhood cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004251-47-BE
- Lead Sponsor
- Z Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): none;Timepoint(s) of evaluation of this end point: None