SinusitisPhase 4NCT00493038
Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis
A Phase 4 study testing Moxifloxacin (Avelox, BAY12-8039) and Amoxicillin/Clavulanate in people with Sinusitis and Bacterial Infections, run by Bayer at 34 sites in Italy.
Trial summary
This is a clinical study organized to collect clinical data to better define the activity of some antimicrobials already marketed in Italy and in the rest of the world for the treatment of acute bacterial rhinosinusitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis, Bacterial Infections
- What is being tested?
- Moxifloxacin (Avelox, BAY12-8039) and Amoxicillin/Clavulanate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 34 sitesItaly
- Study dates
- Feb 2006to Jan 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age >= 18 years
- Clinical diagnosis of acute rhinosinusitis with signs and symptoms present for >/= 5-7 days but < 28 days
- Clinical diagnosis will be confirmed by nasal endoscopic examination
Who cannot join
- History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subject with history of sinus surgery may be included; subjects with recurrent acute sinusitis may be included)
- Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
- Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses
- Known immunodeficiency diseases including, but not limited to: neutropenia (neutrophil count < 1000/mm3), human immunodeficiency virus (HIV) infection (Cluster of differentiation 4 (CD4)+ T-cell count of < 200/mm3). Note: HIV testing is not required
- Received systemic antibacterial therapy likely to be effective in the treatment of acute bacterial sinusitis for more than 24 hours within 5/6 days of enrollment
- Requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol
Show all 20Show fewer
- Currently receiving topical nasal corticosteroids, unless they have been on a stable dose for > 4 weeks prior to enrollment
- Requirement for concomitant therapy with systemic corticosteroids
- Pregnant or breast feeding
- Of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable barrier method of contraception
- Received an investigational drug in the past 30 days
- Previously enrolled in this study
- Unable to take oral medication
- History of allergy to quinolone antibiotics or related compounds and beta-lactams
- History of tendinopathy associated with quinolones
- Known to have congenital or sporadic syndromes of QT interval corrected for rate (QTc) prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine)
- Uncorrected hypokalemia
- End stage liver cirrhosis (class Child-Pugh C)
- Severe renal impairment requiring dialysis
- Diagnosis of rapidly fatal illness with a life expectancy of less than 6 months
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Italy34 sites
Study site
Bari, 70123
Study site
Benevento, 82100
Study site
Bergamo, 24128
Study site
Bologna, 40138
Study site
Bolzano, 39100
Study site
Caserta, 81100
Study site
Catania, 95123
Study site
Catania, 95126
Study site
Cesena, Forlì, 47023
Study site
Comiso, Ragusa, 97013
Study site
Esine, Brescia, 25040
Study site
Florence, 50126
Study site
Foggia, 71100
Study site
Lamezia Terme, Catanzaro, 88046
Study site
Lecce, 73100
Study site
Lecco, 23900
Study site
Matera, 75100
Study site
Milan, 20122
Study site
Milan, 20142
Study site
Monza, Monza-Brianza, 20052
Study site
Novara, 28100
Study site
Pavia, 27100
Study site
Perugia, 06122
Study site
Pisa, 56126
Study site
Roma, 00135
Study site
Roma, 00151
Study site
Roma, 00184
Study site
San Benedetto del Tronto, Ascoli Piceno, 63039
Study site
Sestri Ponente, Genova, 16154
Study site
Siena, 53100
Study site
Torino, 10126
Study site
Torino, 10141
Study site
Treviso, 31100
Study site
Udine, 33100
About this study
Official title: Prospective, Multicenter, Randomized, Double Blind, Parallel Arm Study to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg OD for 7 Days Versus a Standard Antibiotic Therapy for 10 Days in the Treatment of Acute Bacterial Rhino Sinusitis
This is a clinical study organized to collect clinical data to better define the activity of some antimicrobials already marketed in Italy and in the rest of the world for the treatment of acute bacterial rhinosinusitis
- Conditions
- Sinusitis, Bacterial Infections
- Being tested
- Moxifloxacin (Avelox, BAY12-8039), Amoxicillin/Clavulanate
- Keywords
- Treatment of acute bacterial rhinosinusitis
- Medical subject headings
- Sinusitis, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin (Avelox, BAY12-8039)Drug
Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days
Amoxicillin/ClavulanateDrug
Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Experimental | Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID)for 10 days Receives: Drug: Moxifloxacin (Avelox, BAY12-8039) |
| Amoxicillin/Clavulanate | Active comparator | Amoxicillin/clavulanate 1000 mg tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days Receives: Drug: Amoxicillin/Clavulanate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Response (Per-protocol Population)
Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 1-3 days after treatment was assessed by the investigator as "clinical cure"
Measured: At 'Test-of-Cure', Day 1-3 after treatment
Secondary outcomes (4)
Number of Participants With Response (Intent-to-treat Population)
Number of patients in the population who received at least one dose of study medication whose clinical response 1-3 days after treatment was assessed by the investigator as "clinical cure"
Measured: At 'Test-of-Cure', Day 1-3 after treatment
Number of Participants With Response (Per-protocol Population)
Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 24-30 days after treatment was assessed by the investigator as "continued clinical cure"
Measured: End of Follow-up, Day 24-30 after treatment
Number of Participants With Response (Microbiologically Valid Patients)
Bacteriological Efficacy Rate at the 'Test-of-Cure' visit, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.
Measured: At 'Test-of-Cure', Day 1-3 after treatment
Number of Participants With Response (Microbiologically Valid Patients)
Bacteriological Efficacy Rate at the End of Follow-up period, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.
Measured: End of Follow-up, Day 24-30 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startFeb 2006
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: The study was prematurely terminated due to slow enrollment beyond the planned study timelines.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SinusitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493038
- Sponsor's protocol ID
- 11881
- Other IDs
- 2005-002779-34, 2005
- Status last verified
- Nov 2014
- First submitted
- 26 Jun 2007
- Last updated
- 7 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized, Double Blind, Parallel Arm Study to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg OD for 7 Days Versus a Standard Antibiotic Therapy for 10 Days in the Treatment of Acute Bacterial Rhino Sinusitis
- ClinicalTrials.gov ID
- NCT00493038
- Acronym / sponsor ID
- 11881
- Conditions
- Sinusitis, Bacterial Infections
- Keywords
- Treatment of acute bacterial rhinosinusitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated due to slow enrollment beyond the planned study timelines.
- Enrolment
- 293 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 27 Jun 2007 (estimated)
- Results
- Posted 13 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical study organized to collect clinical data to better define the activity of some antimicrobials already marketed in Italy and in the rest of the world for the treatment of acute bacterial rhinosinusitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Experimental | Drug: Moxifloxacin (Avelox, BAY12-8039)Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID)for 10 days |
| Amoxicillin/Clavulanate | Active comparator | Drug: Amoxicillin/ClavulanateAmoxicillin/clavulanate 1000 mg tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18 years
- Clinical diagnosis of acute rhinosinusitis with signs and symptoms present for >/= 5-7 days but < 28 days
- Clinical diagnosis will be confirmed by nasal endoscopic examination
Key exclusion criteria (20 listed)
- History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subject with history of sinus surgery may be included; subjects with recurrent acute sinusitis may be included)
- Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
- Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses
- Known immunodeficiency diseases including, but not limited to: neutropenia (neutrophil count < 1000/mm3), human immunodeficiency virus (HIV) infection (Cluster of differentiation 4 (CD4)+ T-cell count of < 200/mm3). Note: HIV testing is not required
- Received systemic antibacterial therapy likely to be effective in the treatment of acute bacterial sinusitis for more than 24 hours within 5/6 days of enrollment
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 |
|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039)Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days | Drug | Moxifloxacin (Avelox, BAY12-8039) |
| Amoxicillin/ClavulanatePatient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days | Drug | Amoxicillin/Clavulanate |
Primary outcome
Number of Participants With Response (Per-protocol Population)
Time frame: At 'Test-of-Cure', Day 1-3 after treatment
Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 1-3 days after treatment was assessed by the investigator as "clinical cure"
4 secondary outcomes
Number of Participants With Response (Intent-to-treat Population)
Time frame: At 'Test-of-Cure', Day 1-3 after treatment
Number of Participants With Response (Per-protocol Population)
Time frame: End of Follow-up, Day 24-30 after treatment
Number of Participants With Response (Microbiologically Valid Patients)
Time frame: At 'Test-of-Cure', Day 1-3 after treatment
Number of Participants With Response (Microbiologically Valid Patients)
Time frame: End of Follow-up, Day 24-30 after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here and search for information of Bayer products for EuropeLink 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.
Bayer Study Director study director
Bayer
34 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 Moxifloxacin (Avelox, BAY12-8039) and Amoxicillin/Clavulanate in people with Sinusitis and Bacterial Infections, run by Bayer at 34 sites in Italy.
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 20 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: stopped early, as of the sponsor's last update on 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Italy. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Response (Per-protocol Population) (time frame: At 'Test-of-Cure', Day 1-3 after 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 7 Nov 2014.