InfectionPhase 3NCT01109823
Pharmacokinetic Evaluation of Fluoroquinolone Antibiotics Administered Intravenously in Intensive Care Patients With Normal Renal Function and With Renal Hyperfiltration
A Phase 3 study testing intravenous administration of levofloxacin in people with Infection, run by University Ghent at 2 sites in Belgium.
Trial summary
At the intensive care unit (ICU) fluoroquinolone antibiotics, like levofloxacin, are frequently used for the treatment of infections. Adequate blood levels are required for a good efficacy of the antibiotic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- intravenous administration of levofloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesBelgium
- Study dates
- 19 May 2010to 1 Dec 2013
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection.
Who cannot join
- Younger than 18 years
- No informed consent
- No arterial catheter
- Hematocrit ≤ 21
- Pregnancy and lactation
- Creatinine clearance < 80 ml/min
Trial locations and contacts
2 sites in 1 country.
About this study
At the intensive care unit (ICU) fluoroquinolone antibiotics, like levofloxacin, are frequently used for the treatment of infections.
Adequate blood levels are required for a good efficacy of the antibiotic. Due to the fact that levofloxacin is almost completely eliminated renally, the blood levels for this antibiotic are strongly influenced by the renal function. Therefore, this study aims to evaluate the pharmacokinetics of levofloxacin in patients with hyperfiltration, in comparison with critically ill patients with normal renal function.
- Conditions
- Infection
- Being tested
- intravenous administration of levofloxacin
- Keywords
- Patients hospitalized at Intensive Care Unit treated with levofloxacin IV
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous administration of levofloxacinDrug
Intravenous administration of levofloxacin is used.
| Study group | Role | What they receive |
|---|---|---|
| patients with normal renal function | Active comparator | Patients with normal renal function hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection. Receives: Drug: intravenous administration of levofloxacin |
| patients with hyperfiltration | Active comparator | Patients with hyperfiltration hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection. Receives: Drug: intravenous administration of levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the pharmacokinetics of levofloxacin in patients with hyperfiltration, in comparison with critically ill patients with normal renal function.
Measured: 12 hours after start antibiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study start19 May 2010
- Primary completion1 Dec 2013
- Study completion1 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Van Bocxlaer, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109823
- Sponsor's protocol ID
- 2010/167
- Status last verified
- Jun 2021
- First submitted
- 22 Apr 2010
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Evaluation of Fluoroquinolone Antibiotics Administered Intravenously in Intensive Care Patients With Normal Renal Function and With Renal Hyperfiltration
- ClinicalTrials.gov ID
- NCT01109823
- Acronym / sponsor ID
- 2010/167
- Conditions
- Infection
- Keywords
- Patients hospitalized at Intensive Care Unit treated with levofloxacin IV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 19 May 2010 (actual)
- Primary completion
- 1 Dec 2013 (actual)
- Study completion
- 1 Dec 2013 (actual)
- First posted
- 23 Apr 2010 (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.
At the intensive care unit (ICU) fluoroquinolone antibiotics, like levofloxacin, are frequently used for the treatment of infections.
Adequate blood levels are required for a good efficacy of the antibiotic. Due to the fact that levofloxacin is almost completely eliminated renally, the blood levels for this antibiotic are strongly influenced by the renal function. Therefore, this study aims to evaluate the pharmacokinetics of levofloxacin in patients with hyperfiltration, in comparison with critically ill patients with normal renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with normal renal function | Active comparator | Drug: intravenous administration of levofloxacinPatients with normal renal function hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection. |
| patients with hyperfiltration | Active comparator | Drug: intravenous administration of levofloxacinPatients with hyperfiltration hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients hospitalized at the Department Intensive Care Unit who are being treated with levofloxacin I.V. (500mg, twice daily) for an infection.
Key exclusion criteria (6 listed)
- Younger than 18 years
- No informed consent
- No arterial catheter
- Hematocrit ≤ 21
- Pregnancy and lactation
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 |
|---|---|---|
| intravenous administration of levofloxacinIntravenous administration of levofloxacin is used. | Drug | patients with hyperfiltration, patients with normal renal function |
Primary outcome
to evaluate the pharmacokinetics of levofloxacin in patients with hyperfiltration, in comparison with critically ill patients with normal renal function.
Time frame: 12 hours after start antibiotic treatment
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 29 Jun 2021.
Related trials for Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
Jan Van Bocxlaer, PhD principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intravenous administration of levofloxacin in people with Infection, run by University 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 1 inclusion and 6 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 29 Jun 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
to evaluate the pharmacokinetics of levofloxacin in patients with hyperfiltration, in comparison with critically ill patients with normal renal function. (time frame: 12 hours after start antibiotic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2021.