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Trial record 39 of 10353 for:    Anti-Infective Agents AND Bacterial

Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis

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ClinicalTrials.gov Identifier: NCT00493038
Recruitment Status : Terminated (The study was prematurely terminated due to slow enrollment beyond the planned study timelines.)
First Posted : June 27, 2007
Results First Posted : April 13, 2009
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Sinusitis
Bacterial Infections
Interventions Drug: Moxifloxacin (Avelox, BAY12-8039)
Drug: Amoxicillin/Clavulanate
Enrollment 293
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Amoxicillin/Clavulanate
Hide Arm/Group Description 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 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
Period Title: Treatment
Started 147 146
Randomization 147 146
Treated With Study Medication 145 142
Test-of-Cure Visit 123 126
Completed 123 126
Not Completed 24 20
Reason Not Completed
Adverse Event             8             4
Lost to Follow-up             5             3
Withdrawal by Subject             11             12
Other             0             1
Period Title: Follow-up
Started 123 126
Completed 122 126
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Amoxicillin/Clavulanate Total
Hide Arm/Group Description 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 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days Total of all reporting groups
Overall Number of Baseline Participants 145 142 287
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 142 participants 287 participants
41.7  (13.2) 39.7  (13.6) 40.7  (13.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 145 participants 142 participants 287 participants
<=18 years 0 0 0
>18 and <65 years 133 132 265
>=65 years 12 10 22
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 142 participants 287 participants
Female
63
  43.4%
75
  52.8%
138
  48.1%
Male
82
  56.6%
67
  47.2%
149
  51.9%
1.Primary Outcome
Title Number of Participants With Response (Per-protocol Population)
Hide Description 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”
Time Frame At 'Test-of-Cure', Day 1-3 after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Amoxicillin/Clavulanate
Hide Arm/Group Description:
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 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
Overall Number of Participants Analyzed 121 130
Measure Type: Number
Unit of Measure: participants
119 125
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin (Avelox, BAY12-8039), Amoxicillin/Clavulanate
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.1
Confidence Interval 95%
-1.9 to 6.2
Estimation Comments Mean difference denotes the difference of clinical cure rates between the two treatment groups (moxifloxacin minus amoxicillin/clavulanate).
2.Secondary Outcome
Title Number of Participants With Response (Intent-to-treat Population)
Hide Description 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”
Time Frame At 'Test-of-Cure', Day 1-3 after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: participants having at least one observation under study medication
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Amoxicillin/Clavulanate
Hide Arm/Group Description:
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 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
Overall Number of Participants Analyzed 145 142
Measure Type: Number
Unit of Measure: participants
128 127
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin (Avelox, BAY12-8039), Amoxicillin/Clavulanate
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Confidence Interval 95%
-7.9 to 6.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Response (Per-protocol Population)
Hide Description 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”
Time Frame End of Follow-up, Day 24-30 after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Amoxicillin/Clavulanate
Hide Arm/Group Description:
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 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
Overall Number of Participants Analyzed 113 124
Measure Type: Number
Unit of Measure: participants
108 117
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin (Avelox, BAY12-8039), Amoxicillin/Clavulanate
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.7
Confidence Interval 95%
-3.8 to 7.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Response (Microbiologically Valid Patients)
Hide Description 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.
Time Frame At 'Test-of-Cure', Day 1-3 after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients valid per protocol with a causative organism cultured.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Amoxicillin/Clavulanate
Hide Arm/Group Description:
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 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
Overall Number of Participants Analyzed 21 26
Measure Type: Number
Unit of Measure: Participants
Bacteriological success 21 25
Failure 0 1
5.Secondary Outcome
Title Number of Participants With Response (Microbiologically Valid Patients)
Hide Description 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.
Time Frame End of Follow-up, Day 24-30 after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients valid per protocol with a causative organism cultured.
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Amoxicillin/Clavulanate
Hide Arm/Group Description:
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 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
Overall Number of Participants Analyzed 21 26
Measure Type: Number
Unit of Measure: Participants
Bacteriological success 19 23
Failure 0 0
Missing / Indeterminate 2 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Moxifloxacin (Avelox, BAY12-8039) Amoxicillin/Clavulanate
Hide Arm/Group Description 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 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
All-Cause Mortality
Moxifloxacin (Avelox, BAY12-8039) Amoxicillin/Clavulanate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Moxifloxacin (Avelox, BAY12-8039) Amoxicillin/Clavulanate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/145 (0.69%)      1/142 (0.70%)    
General disorders     
Chest pain * 1  1/145 (0.69%)  1 0/142 (0.00%)  0
Infections and infestations     
Sinusitis * 1  0/145 (0.00%)  0 1/142 (0.70%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Moxifloxacin (Avelox, BAY12-8039) Amoxicillin/Clavulanate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/145 (0.00%)      0/142 (0.00%)    
The study was prematurely terminated due to slow enrollment beyond the planned study timelines.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00493038     History of Changes
Other Study ID Numbers: 11881
2005-002779-34 ( EudraCT Number )
First Submitted: June 26, 2007
First Posted: June 27, 2007
Results First Submitted: January 20, 2009
Results First Posted: April 13, 2009
Last Update Posted: November 7, 2014