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NCT02598362 Clinical Trial

Pharmacokinetics of Ciprofloxacin in Pediatric Patients

Urinary Tract Infection Clinical Trial

Official title:
Pharmacokinetics of Ciprofloxacin in Pediatric Patients With Emphasis on Renal Excretion

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02598362
Other study ID # 2014-004638-24
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2015
Est. completion date October 2017

Study information
Verified date September 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date October 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 3 Months to 17 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium Universitair Ziekenhuis Brussel Brussel
Belgium Ghent University Hospital Ghent

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum concentrations 12 hours
Secondary Urine concentrations 12 hours
See also
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