Pharmacokinetics of Ciprofloxacin in Pediatric Patients

Sponsor

University Hospital, Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT02598362

Collaborator

Universitair Ziekenhuis Brussel (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection Pyelonephritis	Drug: ciprofloxacin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pharmacokinetics of Ciprofloxacin in Pediatric Patients With Emphasis on Renal Excretion

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: intravenous Participants who are treated with ciprofloxacin intravenously, at discretion of the treating physician.	Drug: ciprofloxacin Serum and urine concentrations after ciprofloxacin administration. pharmacokinetic testing after ciprofloxacin administration
Other: oral Participants who are treated with ciprofloxacin via the oral route, at discretion of the treating physician.	Drug: ciprofloxacin Serum and urine concentrations after ciprofloxacin administration. pharmacokinetic testing after ciprofloxacin administration

Arm

Intervention/Treatment

Other: intravenous

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

Drug: ciprofloxacin

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

Other: oral

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

Drug: ciprofloxacin

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

Outcome Measures

Primary Outcome Measures

Serum concentrations [12 hours]

Secondary Outcome Measures

Urine concentrations [12 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 17 Years

Sexes Eligible for Study:

All

Accepts 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.