PneumoniaPhase 2NCT00458900
Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients
A Phase 2 study testing IV and enteral administration of moxifloxacin in people with Pneumonia, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
In the Intensive Care (IC)-unit moxifloxacin treatment is often started with intravenous administrations. As moxifloxacin is known to have a high oral bioavailability in healthy volunteers, patients are switched to oral or enteral therapy as soon as possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- IV and enteral administration of moxifloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2007to Sep 2012
- Phase
- Phase 2
- 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
- IC patients treated with 400 mg moxifloxacin IV (once a day) that can be switched to enteral administration of 400 mg moxifloxacin.
- IV steady state
- Hemodynamic stability
- Normal enteral feeding without prokinetics
- Presence of arterial line
- Informed consent
- ≥ 18 jaar
Who cannot join
- Dialysis patients
- Creatinine clearance < 30 ml/min
- Transaminase levels > 5x upper limit
Trial locations and contacts
1 site in 1 country.
About this study
In the Intensive Care (IC)-unit moxifloxacin treatment is often started with intravenous administrations. As moxifloxacin is known to have a high oral bioavailability in healthy volunteers, patients are switched to oral or enteral therapy as soon as possible. However, no data on plasma levels for moxifloxacin during such a switch-therapy in IC-patients are available. Therefore, this study aims to evaluate the moxifloxacin-plasma levels and their inter-individual variability during IV to enteral switch therapy in IC-patients.
- Conditions
- Pneumonia
- Being tested
- IV and enteral administration of moxifloxacin
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV and enteral administration of moxifloxacinDrug
IV and enteral administration of moxifloxacin
| Study group | Role | What they receive |
|---|---|---|
| IV and enteral administration of moxifloxacin | Experimental | IV and enteral administration of moxifloxacin Receives: Drug: IV and enteral administration of moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Pharmacokinetics will be followed.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten Colpaert, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458900
- Sponsor's protocol ID
- 2007/071
- Status last verified
- Dec 2012
- First submitted
- 10 Apr 2007
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT00458900
- Acronym / sponsor ID
- 2007/071
- Conditions
- Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Apr 2007 (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.
In the Intensive Care (IC)-unit moxifloxacin treatment is often started with intravenous administrations. As moxifloxacin is known to have a high oral bioavailability in healthy volunteers, patients are switched to oral or enteral therapy as soon as possible. However, no data on plasma levels for moxifloxacin during such a switch-therapy in IC-patients are available. Therefore, this study aims to evaluate the moxifloxacin-plasma levels and their inter-individual variability during IV to enteral switch therapy in IC-patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV and enteral administration of moxifloxacin | Experimental | Drug: IV and enteral administration of moxifloxacinIV and enteral administration of moxifloxacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- IC patients treated with 400 mg moxifloxacin IV (once a day) that can be switched to enteral administration of 400 mg moxifloxacin.
- IV steady state
- Hemodynamic stability
- Normal enteral feeding without prokinetics
- Presence of arterial line
Key exclusion criteria (3 listed)
- Dialysis patients
- Creatinine clearance < 30 ml/min
- Transaminase levels > 5x upper limit
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 |
|---|---|---|
| IV and enteral administration of moxifloxacinIV and enteral administration of moxifloxacin | Drug | IV and enteral administration of moxifloxacin |
Primary outcome
Pharmacokinetics
Time frame: 2 days
Pharmacokinetics will be followed.
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 10 Dec 2012.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Kirsten Colpaert, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IV and enteral administration of moxifloxacin in people with Pneumonia, run by University Hospital, Ghent at 1 site 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 7 inclusion and 3 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 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pharmacokinetics (time frame: 2 days). 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 10 Dec 2012.