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CompletedNCT02598362Updated Sep 5, 2023

Pharmacokinetics of Ciprofloxacin in Pediatric Patients

A Phase 4 interventional study of ciprofloxacin in Urinary Tract Infection and Pyelonephritis, sponsored by University Hospital, Ghent. Completed at 2 sites in Belgium. Open to participants aged 3 Months to 17 Years. Per ClinicalTrials.gov, last updated 2023-09-05.

Sponsored by University Hospital, Ghent · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Ages
3 Months to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Urinary Tract Infection
  • Pyelonephritis

Keywords

  • ciprofloxacin
  • pharmacokinetics
  • excretion
  • clearance
  • infant
  • children
  • adolescent
03

In context

Urinary Tract Infections

803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.

This study's enrollment of 22 is below the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • pregnancy
  • impaired renal function as defined by 2x serum creatinine level for age and sex
  • epilepsy
  • myasthenia gravis
  • long -syndrome
  • glucose 6 phosphatase deficiency (G6PD)
  • allergy to one of the substances of cipro
  • concomitant use of
  • for the oral group: co medication of antacidic drugs, ferrofumarate, calcium, magnesium or Zinc supplements.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Other
    intravenous

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

    Drug: ciprofloxacin

  • Other
    oral

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

    Drug: ciprofloxacin

Interventions

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

06

What researchers measure

Primary outcomes

  1. Serum concentrations

    Time frame: 12 hours

Secondary outcomes

  1. Urine concentrations

    Time frame: 12 hours

07

Study locations

2 sites
  • Universitair Ziekenhuis Brussel
    Brussel, Belgium
  • Ghent University Hospital
    Ghent, 9000, Belgium
08

References and documents

Publications

  • Meesters K, Michelet R, Mauel R, Raes A, Van Bocxlaer J, Vande Walle J, Vermeulen A. Results of a Multicenter Population Pharmacokinetic Study of Ciprofloxacin in Children with Complicated Urinary Tract Infection. Antimicrob Agents Chemother. 2018 Aug 27;62(9):e00517-18. doi: 10.1128/AAC.00517-18. Print 2018 Sep. PubMed 29987142 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02598362
Responsible party
Sponsor
First posted
Nov 5, 2015
Start date
Apr 2015
Primary completion
May 2017
Completion
Oct 2017
Last update
Sep 5, 2023

Study contacts

Johan Vande Walle, MD PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ciprofloxacin

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