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Completed

NCT Number: NCT02598362

Pharmacokinetics of Ciprofloxacin in Pediatric Patients

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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Key information

Conditions

Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Nephritis Nephritis, Interstitial Pyelitis Pyelonephritis Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

3 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitair Ziekenhuis Brussel, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ciprofloxacin

Drug

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

Primary outcomes

  1. Serum concentrations

    Time frame: 12 hours

Secondary outcomes

  1. Urine concentrations

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Universitair Ziekenhuis Brussel

Registry information

Official study title

Pharmacokinetics of Ciprofloxacin in Pediatric Patients With Emphasis on Renal Excretion

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 5, 2015
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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