Back to resultsPharmacokinetics of Ciprofloxacin in Pediatric Patients
Primary Purpose
Urinary Tract Infection, Pyelonephritis
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
ciprofloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infection focused on measuring ciprofloxacin, pharmacokinetics, excretion, clearance, infant, children, adolescent
Eligibility Criteria
Inclusion Criteria:
- age between 3 months and 17 years of age
- confirmed diagnosis of febrile urinary tract infection (a rectal body temperature of 38.5 °C.in combination with either significant leukocyturia or a positive urine nitrite test in a reliable urine sample.
- indication for treatment or uroprophylaxis with ciprofloxacin at discretion of the treating physician.
Exclusion Criteria:
- pregnancy
- impaired renal function as defined by 2x serum creatinine level for age and sex
- epilepsy
- myasthenia gravis
- long QT-syndrome
- glucose 6 phosphatase deficiency (G6PD)
- allergy to one of the substances of cipro
- concomitant use of corticosteroids
- for the oral group: co medication of antacidic drugs, ferrofumarate, calcium, magnesium or Zinc supplements.
Sites / Locations
- Universitair Ziekenhuis Brussel
- Ghent University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
intravenous
oral
Arm Description
Participants who are treated with ciprofloxacin intravenously, at discretion of the treating physician.
Participants who are treated with ciprofloxacin via the oral route, at discretion of the treating physician.
Outcomes
Primary Outcome Measures
Serum concentrations
Secondary Outcome Measures
Urine concentrations
Full Information
NCT ID
NCT02598362
First Posted
November 4, 2015
Last Updated
September 1, 2023
Sponsor
University Hospital, Ghent
Collaborators
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT02598362
Brief Title
Pharmacokinetics of Ciprofloxacin in Pediatric Patients
Official Title
Pharmacokinetics of Ciprofloxacin in Pediatric Patients With Emphasis on Renal Excretion
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Universitair Ziekenhuis Brussel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Measuring serum and urine concentrations of ciprofloxacin after IV and oral administration in children aged 3 months - 17 years who are treated for urinary tract infections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection, Pyelonephritis
Keywords
ciprofloxacin, pharmacokinetics, excretion, clearance, infant, children, adolescent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intravenous
Arm Type
Other
Arm Description
Participants who are treated with ciprofloxacin intravenously, at discretion of the treating physician.
Arm Title
oral
Arm Type
Other
Arm Description
Participants who are treated with ciprofloxacin via the oral route, at discretion of the treating physician.
Intervention Type
Drug
Intervention Name(s)
ciprofloxacin
Intervention Description
Serum and urine concentrations after ciprofloxacin administration. pharmacokinetic testing after ciprofloxacin administration
Primary Outcome Measure Information:
Title
Serum concentrations
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Urine concentrations
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 3 months and 17 years of age
confirmed diagnosis of febrile urinary tract infection (a rectal body temperature of 38.5 °C.in combination with either significant leukocyturia or a positive urine nitrite test in a reliable urine sample.
indication for treatment or uroprophylaxis with ciprofloxacin at discretion of the treating physician.
Exclusion Criteria:
pregnancy
impaired renal function as defined by 2x serum creatinine level for age and sex
epilepsy
myasthenia gravis
long QT-syndrome
glucose 6 phosphatase deficiency (G6PD)
allergy to one of the substances of cipro
concomitant use of corticosteroids
for the oral group: co medication of antacidic drugs, ferrofumarate, calcium, magnesium or Zinc supplements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Vande Walle, MD PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Brussel
Country
Belgium
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29987142
Citation
Meesters K, Michelet R, Mauel R, Raes A, Van Bocxlaer J, Vande Walle J, Vermeulen A. Results of a Multicenter Population Pharmacokinetic Study of Ciprofloxacin in Children with Complicated Urinary Tract Infection. Antimicrob Agents Chemother. 2018 Aug 27;62(9):e00517-18. doi: 10.1128/AAC.00517-18. Print 2018 Sep.
Results Reference
derived
Learn more about this trial
Pharmacokinetics of Ciprofloxacin in Pediatric Patients
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