Pharmacokinetics of Ciprofloxacin in Pediatric Patients (NCT02598362) | Clinical Trial Compass
CompletedPhase 4
Pharmacokinetics of Ciprofloxacin in Pediatric Patients
Belgium22 participantsStarted 2015-04
Plain-language 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.
Who can participate
Age range
3 Months – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial already completed and was studying how ciprofloxacin moves through children's bodies, has enough data been published from it that my child's doctor can use those findings to guide dosing decisions right now?
2This was a Phase 4 study, which means ciprofloxacin was already approved before this trial started — so how does what was learned here about blood concentration levels in kids change how doctors think about the right dose for my child's age and weight?
3Ciprofloxacin is not always the first choice for urinary tract infections or pyelonephritis in children — are there other antibiotics that are better established for my child's situation, and would my doctor consider those before ciprofloxacin?
4Since the trial focused on measuring ciprofloxacin levels in the blood, does my child's doctor have any concerns about whether standard doses reach the right concentration to treat a kidney infection like pyelonephritis effectively in kids?
5Are there specific factors about my child — such as their kidney function, age, or weight — that would make the pharmacokinetic findings from this trial especially relevant or potentially concerning for how they would process ciprofloxacin?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.