Pharmacokinetics of Ciprofloxacin in Pediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Urinary Tract Infection Pyelonephritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intravenous

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

Group Type OTHER

ciprofloxacin

Intervention Type DRUG

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

oral

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

Group Type OTHER

ciprofloxacin

Intervention Type DRUG

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

Interventions

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ciprofloxacin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

3 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No