Pharmacokinetics of Ciprofloxacin in Pediatric Patients

September 1, 2023 updated by: University Hospital, Ghent

Pharmacokinetics of Ciprofloxacin in Pediatric Patients With Emphasis on Renal Excretion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium
        • Universitair Ziekenhuis Brussel
      • Ghent, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum concentrations
Time Frame: 12 hours
12 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Urine concentrations
Time Frame: 12 hours
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Johan Vande Walle, MD PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimated)

November 5, 2015

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-004638-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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