Pneumonia, AspirationPhase 3NCT01045902
BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia
A Phase 3 study testing Avelox (Moxifloxacin, BAY12-8039) and Sulbactam/Ampicillin in people with Pneumonia, Aspiration and Lung Abscess, run by Bayer at 15 sites in Germany.
Trial summary
The purpose of this trial is to determine the efficacy and safety of Moxifloxacin in comparison to Sulbactam/Ampicillin in the treatment of pulmonary abscesses and aspiration pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Aspiration, Lung Abscess
- What is being tested?
- Avelox (Moxifloxacin, BAY12-8039) and Sulbactam/Ampicillin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 15 sitesGermany
- Study dates
- Feb 2001to Jan 2005
- 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
- Male or female patients aged 18 years or above
- The primary diagnosis is community or hospital acquired primary pulmonary abscess or aspiration pneumonia, requiring initial parenteral treatment
Who cannot join
- Known hypersensitivity to fluoroquinolones and/or ß-lactams
- Patients with mechanical ventilation lasting more than 48 hours prior to enrollment, with poststenotic pneumonia, infarction pneumonia, pulmonary tuberculosis, lung abscess/pneumonia with concomitant endocarditis
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Germany15 sites
Study site
Berlin, State of Berlin, 13353
Study site
Berlin, State of Berlin, 14165
Study site
Frankfurt am Main, Hesse, 60596
Study site
Hildesheim, Lower Saxony, 31134
Study site
Leipzig, Saxony, 04129
Study site
Lübeck, Schleswig-Holstein, 23538
Study site
Lüdenscheid, North Rhine-Westphalia, 58515
Study site
Magdeburg, Saxony-Anhalt, 39112
Study site
Mannheim, Baden-Wurttemberg, 68167
Study site
Nuremberg, Bavaria, 90419
Study site
Oberhausen, North Rhine-Westphalia, 46045
Study site
Paderborn, North Rhine-Westphalia, 33098
Study site
Regensburg, Bavaria, 93053
Study site
Rotenburg (Wümme), Lower Saxony, 27356
Study site
Treuenbrietzen, Brandenburg, 14929
About this study
Official title: Prospective, Multi-center, Randomized, Non-blind Trial to Assess the Efficacy and Safety of Moxifloxacin Versus Sulbactam/Ampicillin in the Treatment of Pulmonary Abscess and Aspiration Pneumonia
The purpose of this trial is to determine the efficacy and safety of Moxifloxacin in comparison to Sulbactam/Ampicillin in the treatment of pulmonary abscesses and aspiration pneumonia.
- Conditions
- Pneumonia, Aspiration, Lung Abscess
- Being tested
- Avelox (Moxifloxacin, BAY12-8039), Sulbactam/Ampicillin
- Keywords
- Pulmonary Abscess, Aspiration Pneumonia
- Medical subject headings
- Pneumonia, Aspiration, Lung Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avelox (Moxifloxacin, BAY12-8039)Drug
Moxifloxacin, 400 mg iv, od, switch after 6 doses (6 days) to 400 mg Moxifloxacin oral, od
Sulbactam/AmpicillinDrug
Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Avelox (Moxifloxacin, BAY12-8039) |
| Arm 2 | Active comparator | Not described Receives: Drug: Sulbactam/Ampicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events
Measured: Up to 30 days after end of treatment with study medication for serious adverse events
Secondary outcomes (1)
Clinical Response
Measured: Regulary doing i.v. treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startFeb 2001
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, AspirationStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045902
- Sponsor's protocol ID
- 10381
- Status last verified
- Jan 2010
- First submitted
- 8 Jan 2010
- Last updated
- 11 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Randomized, Non-blind Trial to Assess the Efficacy and Safety of Moxifloxacin Versus Sulbactam/Ampicillin in the Treatment of Pulmonary Abscess and Aspiration Pneumonia
- ClinicalTrials.gov ID
- NCT01045902
- Acronym / sponsor ID
- 10381
- Conditions
- Pneumonia, Aspiration, Lung Abscess
- Keywords
- Pulmonary Abscess, Aspiration Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- Study completion
- Jan 2005 (actual)
- First posted
- 11 Jan 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.
The purpose of this trial is to determine the efficacy and safety of Moxifloxacin in comparison to Sulbactam/Ampicillin in the treatment of pulmonary abscesses and aspiration pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Avelox (Moxifloxacin, BAY12-8039) |
| Arm 2 | Active comparator | Drug: Sulbactam/Ampicillin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female patients aged 18 years or above
- The primary diagnosis is community or hospital acquired primary pulmonary abscess or aspiration pneumonia, requiring initial parenteral treatment
Key exclusion criteria (2 listed)
- Known hypersensitivity to fluoroquinolones and/or ß-lactams
- Patients with mechanical ventilation lasting more than 48 hours prior to enrollment, with poststenotic pneumonia, infarction pneumonia, pulmonary tuberculosis, lung abscess/pneumonia with concomitant endocarditis
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 |
|---|---|---|
| Avelox (Moxifloxacin, BAY12-8039)Moxifloxacin, 400 mg iv, od, switch after 6 doses (6 days) to 400 mg Moxifloxacin oral, od | Drug | Arm 1 |
| Sulbactam/AmpicillinSulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid | Drug | Arm 2 |
Primary outcome
Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events
Time frame: Up to 30 days after end of treatment with study medication for serious adverse events
1 secondary outcome
Clinical Response
Time frame: Regulary doing i.v. 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 11 Jan 2010.
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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.
Bayer Study Director study director
Bayer
15 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 Avelox (Moxifloxacin, BAY12-8039) and Sulbactam/Ampicillin in people with Pneumonia, Aspiration and Lung Abscess, run by Bayer at 15 sites in Germany.
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 2 inclusion and 2 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 11 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany. 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?
Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events (time frame: Up to 30 days after end of treatment with study medication for serious adverse events). 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 11 Jan 2010.