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Pharmacokinetics of Ciprofloxacin in Pediatric Patients

Pharmacokinetics of Ciprofloxacin in Pediatric Patients With Emphasis on Renal Excretion

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02598362
Enrollment
22
Registered
2015-11-05
Start date
2015-04-30
Completion date
2017-10-31
Last updated
2023-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pyelonephritis, Urinary Tract Infection

Keywords

ciprofloxacin, pharmacokinetics, excretion, clearance, infant, children, adolescent

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.

Interventions

DRUGciprofloxacin

Serum and urine concentrations after ciprofloxacin administration. pharmacokinetic testing after ciprofloxacin administration

Sponsors

Universitair Ziekenhuis Brussel
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Months to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Serum concentrations12 hours

Secondary

MeasureTime frame
Urine concentrations12 hours

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026