Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis (NCT NCT00493038)
NCT ID: NCT00493038
Last Updated: 2014-11-07
Results Overview
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"
TERMINATED
PHASE4
293 participants
At 'Test-of-Cure', Day 1-3 after treatment
2014-11-07
Participant Flow
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.
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.
Participant milestones
| Measure |
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
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
|
|---|---|---|
|
Treatment
STARTED
|
147
|
146
|
|
Treatment
Randomization
|
147
|
146
|
|
Treatment
Treated With Study Medication
|
145
|
142
|
|
Treatment
Test-of-Cure Visit
|
123
|
126
|
|
Treatment
COMPLETED
|
123
|
126
|
|
Treatment
NOT COMPLETED
|
24
|
20
|
|
Follow-up
STARTED
|
123
|
126
|
|
Follow-up
COMPLETED
|
122
|
126
|
|
Follow-up
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
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
|
|---|---|---|
|
Treatment
Adverse Event
|
8
|
4
|
|
Treatment
Lost to Follow-up
|
5
|
3
|
|
Treatment
Withdrawal by Subject
|
11
|
12
|
|
Treatment
Other
|
0
|
1
|
|
Follow-up
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis
Baseline characteristics by cohort
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=145 Participants
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
n=142 Participants
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
n=287 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 13.2 • n=99 Participants
|
39.7 years
STANDARD_DEVIATION 13.6 • n=107 Participants
|
40.7 years
STANDARD_DEVIATION 13.4 • n=206 Participants
|
|
Age, Customized
<=18 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Age, Customized
>18 and <65 years
|
133 participants
n=99 Participants
|
132 participants
n=107 Participants
|
265 participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
12 participants
n=99 Participants
|
10 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
149 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At 'Test-of-Cure', Day 1-3 after treatmentPopulation: 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
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"
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=121 Participants
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
n=130 Participants
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
|
|---|---|---|
|
Number of Participants With Response (Per-protocol Population)
|
119 participants
|
125 participants
|
SECONDARY outcome
Timeframe: At 'Test-of-Cure', Day 1-3 after treatmentPopulation: ITT population: participants having at least one observation under study medication
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"
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=145 Participants
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
n=142 Participants
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
|
|---|---|---|
|
Number of Participants With Response (Intent-to-treat Population)
|
128 participants
|
127 participants
|
SECONDARY outcome
Timeframe: End of Follow-up, Day 24-30 after treatmentPopulation: 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
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"
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=113 Participants
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
n=124 Participants
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
|
|---|---|---|
|
Number of Participants With Response (Per-protocol Population)
|
108 participants
|
117 participants
|
SECONDARY outcome
Timeframe: At 'Test-of-Cure', Day 1-3 after treatmentPopulation: Patients valid per protocol with a causative organism cultured.
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.
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=21 Participants
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
n=26 Participants
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
|
|---|---|---|
|
Number of Participants With Response (Microbiologically Valid Patients)
Bacteriological success
|
21 Participants
|
25 Participants
|
|
Number of Participants With Response (Microbiologically Valid Patients)
Failure
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: End of Follow-up, Day 24-30 after treatmentPopulation: Patients valid per protocol with a causative organism cultured.
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.
Outcome measures
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=21 Participants
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
n=26 Participants
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
|
|---|---|---|
|
Number of Participants With Response (Microbiologically Valid Patients)
Bacteriological success
|
19 Participants
|
23 Participants
|
|
Number of Participants With Response (Microbiologically Valid Patients)
Failure
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response (Microbiologically Valid Patients)
Missing / Indeterminate
|
2 Participants
|
3 Participants
|
Adverse Events
Moxifloxacin (Avelox, BAY12-8039)
Amoxicillin/Clavulanate
Serious adverse events
| Measure |
Moxifloxacin (Avelox, BAY12-8039)
n=145 participants at risk
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
n=142 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Sinusitis
|
0.00%
0/145
|
0.70%
1/142 • Number of events 1
|
|
General disorders
Chest pain
|
0.69%
1/145 • Number of events 1
|
0.00%
0/142
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER