Pharmacokinetics of Ciprofloxacin in Pediatric Patients

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infection; Pyelonephritis

Treatments: Drug: ciprofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02598362

2014-004638-24

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 3 months to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

22 participants in 2 patient groups

intravenous

Other group

Description:

Participants who are treated with ciprofloxacin intravenously, at discretion of the treating physician.

Treatment:

Drug: ciprofloxacin

oral

Other group

Description:

Participants who are treated with ciprofloxacin via the oral route, at discretion of the treating physician.

Treatment:

Drug: ciprofloxacin