Pharmacokinetics of Ciprofloxacin in Pediatric Patients
1 other identifier
interventional
22
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2015
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 4, 2015
CompletedFirst Posted
Study publicly available on registry
November 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedSeptember 5, 2023
September 1, 2023
2.1 years
November 4, 2015
September 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum concentrations
12 hours
Secondary Outcomes (1)
Urine concentrations
12 hours
Study Arms (2)
intravenous
OTHERParticipants who are treated with ciprofloxacin intravenously, at discretion of the treating physician.
oral
OTHERParticipants who are treated with ciprofloxacin via the oral route, at discretion of the treating physician.
Interventions
Serum and urine concentrations after ciprofloxacin administration. pharmacokinetic testing after ciprofloxacin administration
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- Universitair Ziekenhuis Brusselcollaborator
Study Sites (2)
Universitair Ziekenhuis Brussel
Brussels, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
Related Publications (1)
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.
PMID: 29987142DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johan Vande Walle, MD PhD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2015
First Posted
November 5, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2017
Study Completion
October 1, 2017
Last Updated
September 5, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share