Urinary Tract InfectionPhase 4NCT02598362
Pharmacokinetics of Ciprofloxacin in Pediatric Patients
A Phase 4 study testing ciprofloxacin in people with Urinary Tract Infection and Pyelonephritis, run by University Hospital, Ghent at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Urinary Tract Infection, Pyelonephritis
- What is being tested?
- ciprofloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesBelgium
- Study dates
- Apr 2015to Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Universitair Ziekenhuis Brussel
Brussels
Ghent University Hospital
Ghent, 9000
About this study
Official title: 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.
- Conditions
- Urinary Tract Infection, Pyelonephritis
- Being tested
- ciprofloxacin
- Keywords
- ciprofloxacin, pharmacokinetics, excretion, clearance, infant, children, adolescent
- Medical subject headings
- Urinary Tract Infections, Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofloxacinDrug
Serum and urine concentrations after ciprofloxacin administration. pharmacokinetic testing after ciprofloxacin administration
| Study group | Role | What they receive |
|---|---|---|
| intravenous | Other | Participants who are treated with ciprofloxacin intravenously, at discretion of the treating physician. Receives: Drug: ciprofloxacin |
| oral | Other | Participants who are treated with ciprofloxacin via the oral route, at discretion of the treating physician. Receives: Drug: ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentrations
Measured: 12 hours
Secondary outcomes (1)
Urine concentrations
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Responsible party
- Sponsor
- Investigators
- Johan Vande Walle, MD PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598362
- Sponsor's protocol ID
- 2014-004638-24
- Other IDs
- 2014
- Status last verified
- Sep 2023
- First submitted
- 4 Nov 2015
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Ciprofloxacin in Pediatric Patients With Emphasis on Renal Excretion
- ClinicalTrials.gov ID
- NCT02598362
- Acronym / sponsor ID
- 2014-004638-24
- Conditions
- Urinary Tract Infection, Pyelonephritis
- Keywords
- ciprofloxacin, pharmacokinetics, excretion, clearance, infant, children, adolescent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Study start
- Apr 2015
- Primary completion
- May 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous | Other | Drug: ciprofloxacinParticipants who are treated with ciprofloxacin intravenously, at discretion of the treating physician. |
| oral | Other | Drug: ciprofloxacinParticipants who are treated with ciprofloxacin via the oral route, at discretion of the treating physician. |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- pregnancy
- impaired renal function as defined by 2x serum creatinine level for age and sex
- epilepsy
- myasthenia gravis
- long QT-syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ciprofloxacinSerum and urine concentrations after ciprofloxacin administration. pharmacokinetic testing after ciprofloxacin administration | Drug | intravenous, oral |
Primary outcome
Serum concentrations
Time frame: 12 hours
1 secondary outcome
Urine concentrations
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Derived from this study: PubMed 29987142Meesters 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Vande Walle, MD PhD principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ciprofloxacin in people with Urinary Tract Infection and Pyelonephritis, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentrations (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02598362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.