Phase 3
N=374
BAY12-8039: 5 Days for Sinusitis vs Placebo
Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT00492024 ↗Enrolled (actual)
374
Serious AEs
0.5%
Results posted
Dec 2009
Primary outcome: Primary: Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT)) — 78.1; 66.7; 19.2; 33.3 Percentage of subjects — p=0.189
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Moxifloxacin (Avelox, BAY12-8039) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT)) |
78.1; 66.7; 19.2; 33.3; 2.7; 0 | 0.189 |
| SECONDARY Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach |
14; 7; 26; 10; 31; 13 | — |
| SECONDARY Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach |
22; 15; 31; 17; 35; 17 | — |
| SECONDARY Percentage of Subjects With Clinical Improvement During Therapy |
84.9; 73.3; 4.1; 4.4; 11.0; 22.2 | — |
| SECONDARY Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up |
73.9; 57.7; 21.9; 40.0; 4.1; 2.2 | — |
Summary
The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, therefore in this study Avelox is considered an investigational drug. In this study Avelox will be compared to placebo.
Eligibility Criteria
Inclusion Criteria
Subjects must meet all the following criteria at the time of enrollment:
- Age >/= 18 years
- Clinical diagnosis of acute bacterial sinusitis with signs and symptoms present for = 7 days but < 28 days as defined by A), radiographic, and B) clinical criteria, as follows:
- Radiographic Criteria: The presence of one or more of the following on a radiographic paranasal sinus film (Waters' view): - Evidence of air-fluid levels - Opacification
- Clinical Criteria: The presence of two major symptoms, or the presence of at least one major and one minor symptom as defined in the list below:
- Major symptoms: - Purulent anterior or posterior nasal discharge - Unilateral facial pain or malar tenderness
- Minor symptoms: - Frontal headache - Fever (oral = 38.0°C/100.4°F, tympanic = 38.5°C/101.2°F, axillary = 37.5°C/99.5°F) - Culture material obtained by sinus puncture; the aspirated specimen sent for Gram stain, quantitative culture and susceptibility testing prior to initiation of antimicrobial therapy
Exclusion Criteria
Subjects with one or more of the following criteria will not be eligible for this study:
- History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subjects with recurrent acute sinusitis will be included)
- History of sinus surgery (antral sinus puncture is not considered as a surgery)
- 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
Data sourced from ClinicalTrials.gov (NCT00492024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.