Pharmacokinetics of Ciprofloxacin in Pediatric Patients

Overview

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.

Full Title of Study: “Pharmacokinetics of Ciprofloxacin in Pediatric Patients With Emphasis on Renal Excretion”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2017

Interventions

  • Drug: ciprofloxacin
    • Serum and urine concentrations after ciprofloxacin administration. pharmacokinetic testing after ciprofloxacin administration

Arms, Groups and Cohorts

  • Other: intravenous
    • Participants who are treated with ciprofloxacin intravenously, at discretion of the treating physician.
  • Other: oral
    • Participants who are treated with ciprofloxacin via the oral route, at discretion of the treating physician.

Clinical Trial Outcome Measures

Primary Measures

  • Serum concentrations
    • Time Frame: 12 hours

Secondary Measures

  • Urine concentrations
    • Time Frame: 12 hours

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Ghent
  • Collaborator
    • Universitair Ziekenhuis Brussel
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Johan Vande Walle, MD PhD, Principal Investigator, University Hospital, Ghent

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