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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-002779-34 | EudraCT Number |
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The study was prematurely terminated due to slow enrollment beyond the planned study timelines.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039) | Drug | Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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" | At 'Test-of-Cure', Day 1-3 after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | At 'Test-of-Cure', Day 1-3 after treatment |
| Number of Participants With Response (Per-protocol Population) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Benedetto del Tronto | Ascoli Piceno | 63039 | Italy | |||
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| Label | URL |
|---|---|
| Click here and search for information of Bayer products for Europe | View source |
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Number of patients screened: 293 Number of patients having at least one observation under study medication: 287 (intention-to-treat population = ITT population) Number of patients adhered to major predefined aspects of the study protocol: 251 (per-protocol population = PP population). Primary population for efficacy was PP.
Enrollment started on 13 Feb 2006 and the last study visit occurred on 20 Jan 2008. The study was conducted at 34 active otorhinolaryngology centers in Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Amoxicillin/Clavulanate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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| Amoxicillin/Clavulanate | Drug | Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days |
|
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" |
| 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. | 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. | End of Follow-up, Day 24-30 after treatment |
| Esine |
| Brescia |
| 25040 |
| Italy |
| Lamezia Terme | Catanzaro | 88046 | Italy |
| Cesena | Forlì | 47023 | Italy |
| Sestri Ponente | Genova | 16154 | Italy |
| Monza | Monza-Brianza | 20052 | Italy |
| Comiso | Ragusa | 97013 | Italy |
| Bari | 70123 | Italy |
| Benevento | 82100 | Italy |
| Bergamo | 24128 | Italy |
| Bologna | 40138 | Italy |
| Bolzano | 39100 | Italy |
| Caserta | 81100 | Italy |
| Catania | 95123 | Italy |
| Catania | 95126 | Italy |
| Florence | 50126 | Italy |
| Foggia | 71100 | Italy |
| Lecce | 73100 | Italy |
| Lecco | 23900 | Italy |
| Matera | 75100 | Italy |
| Milan | 20122 | Italy |
| Milan | 20142 | Italy |
| Novara | 28100 | Italy |
| Pavia | 27100 | Italy |
| Perugia | 06122 | Italy |
| Pisa | 56126 | Italy |
| Roma | 00135 | Italy |
| Roma | 00151 | Italy |
| Roma | 00184 | Italy |
| Siena | 53100 | Italy |
| Torino | 10126 | Italy |
| Torino | 10141 | Italy |
| Treviso | 31100 | Italy |
| Udine | 33100 | Italy |
Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days |
| Randomization |
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| Treated With Study Medication |
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| Test-of-Cure Visit |
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| COMPLETED |
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| NOT COMPLETED |
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| Follow-up |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Amoxicillin/Clavulanate | Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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" | Per Protocol population: subjects to meet all of the following (1) Clinical evaluation was performed at TOC visit (2) No other systemic antibacterial agent was administered with study drug up to TOC visit (3) Adequate treatment compliance (≥ 80% of study drug taken) (4) Random code not broken (5) No protocol violation affecting treatment efficacy | Posted | Number | participants | At 'Test-of-Cure', Day 1-3 after treatment |
|
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| Secondary | 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" | ITT population: participants having at least one observation under study medication | Posted | Number | participants | At 'Test-of-Cure', Day 1-3 after treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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" | PP population at end FU: (1) Clinical evaluation was performed at the TOC visit (2) No other systemic antibacterial agent was administered with study drug up to the TOC visit (3) Adequate treatment compliance (≥80% of study drug taken) (4) Random code not broken (5) No protocol violation affecting treatment efficacy (6) FU assessment available | Posted | Number | participants | End of Follow-up, Day 24-30 after treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Patients valid per protocol with a causative organism cultured. | Posted | Number | Participants | At 'Test-of-Cure', Day 1-3 after treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Patients valid per protocol with a causative organism cultured. | Posted | Number | Participants | End of Follow-up, Day 24-30 after treatment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 145 | 0 | 145 | ||
| EG001 | Amoxicillin/Clavulanate | Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days | 1 | 142 | 0 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 10.1 | Non-systematic Assessment |
|
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The study was prematurely terminated due to slow enrollment beyond the planned study timelines.
The results of the trial as well as any discoveries and inventions, are exclusive property of the Promoter.
Publications on scientific review, comments or presentations about the study in scientific environment must be agreed between the Sponsor and the investigator who engages to submit to Bayer, any publication by sending one text or presentations at least 60 days before the expected publication for comments and corrections.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| >18 and <65 years |
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| >=65 years |
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| Male |
|
The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: "Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference...", pg.1447-1454 [1990]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population.
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| Participants |
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