Pharmacokinetics of Ciprofloxacin in Pediatric Patients

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Collaborator: Universitair Ziekenhuis Brussel
• Treatments: Ciprofloxacin

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.