Sinusitis
Conditions
Brief summary
Primary objective: * To demonstrate that the clinical efficacy of telithromycin (800 mg od for 5 days) is non-inferior to amoxicillin-clavulanic acid (875/125 mg bid for 10 days) at the test-of-cure (TOC) visit (Day 17-21) in subjects with acute bacterial sinusitis (ABS). Secondary objective(s): * To assess the time to resolution of signs and symptoms between the baseline (Day 1) and TOC (Day 17-21) visits, * To assess the rate of clinical relapse at the follow-up visit (Day 41-49), * To assess health economic outcome until follow-up visit (Day 41-49), * To assess quality of life up to the follow-up visit (Day 41-49), * To compare the safety of telithromycin and amoxicillin-clavulanic acid, * To compare the bacteriologic outcome of both treatments as observed at TOC (Day 17-21) and at follow-up visit (Day 41-49),in subjects with ABS.
Interventions
DRUGTelithromycin
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non pregnant female * Outpatients with a clinical diagnosis of ABS, based on the presence of: * Signs and symptoms lasting longer than 7 days and less than 28 days, * Purulent anterior or posterior nasal discharge * One additional major sign and symptom or 2 minor signs and symptoms. The major and minor signs and symptoms will be defined as the following: * Major signs and symptoms: facial pain/pressure/tightness over the maxillary sinuses, nasal congestion/obstruction, change in the perception of smell (hypoanosmia/anosmia), fever (temperature \> 38° C \[100.4 F\] (oral)/ \> 38.5° C \[101.2 F\] (tympanic)/ \> 39° C \[102.2 F\] (rectal)), * Minor signs and symptoms: headache, halitosis, dental pain, ear pressure/fullness, cough, fatigue, * Subjects with abnormal maxillary sinus x-rays (Waters views and additional views if necessary) or limited sinus CT scans or sinus ultrasound in the previous 48 hours before inclusion defined as the presence of at least 1 of the following homolateral radiological criteria: * Presence of air/fluid level, * Total opacification, * Mucosal thickening \> 10 mm, Written informed consent must be obtained before enrollment in the study for all subjects.
Exclusion criteria
* Related to the disease : * History of recurrent sinusitis (more than (\>) 3 episodes of sinusitis requiring antibiotic therapy within the previous 12 months), * Chronic sinusitis (signs and symptoms lasting more than 28 days), * Suspicion of sinusitis requiring treatment other than oral antibiotic therapy, * Suspicion of concomitant odontologic infection, requiring antibiotic therapy or surgery * Nosocomial sinusitis (eg, hospitalization more than 48 hours or non ambulatory institutional confinement including nursing homes within 2 weeks), * Known major obstructive anatomic/functional lesions in nasopharynx: anatomical blockage (eg, chronic nasal polyps, severely deviated septum), cystic fibrosis, immotile cilia, sinus polyps, * Use of nasal, nasogastric or nasotracheal catheters, * Sinus puncture and/or sinus lavage in the previous 7 days, * Previous sinus surgery in the last 6 months, * Maxillary sinusitis requiring immediate surgery * Symptomatic allergic sinusitis and/or allergic rhinitis, * Exposition to environmental irritants in the workplace * Related to the previous/concomitant medication : * Previous treatment with intranasal, oral or parenteral antibiotic (more than 24 hours intake) within 30 days prior enrollment, * Intranasal corticosteroid or short term systemic corticosteroid use within the past 10 days prior to enrollment, * Maintenance systemic corticosteroid therapy on inclusion (\>10 mg/day equivalent prednisone), * Subjects who are long-term users (\> 4 weeks) of nasal decongestants like oxymetazoline 0.05%, * Required on-therapy contra-indicated medications with study treatment (according to the country labeling): ergot alkaloids derivatives (such as ergotamine and dihydroergotamine), cisapride, pimozide, astemizole, terfenadine, simvastatin, atorvastatin and lovastatin, allopurinol, methotrexate, probenecid, * Previous treatment within 2 weeks before enrollment or during the study medication with rifampicin, phenytoin, carbamazepine, St-John's-wort, phenobarbital, * Treatment with any investigational product in the last 30 days before study entry. * Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical success rate at the TOC visit in the per protocol population. | During all the study conduct |
Secondary
| Measure | Time frame |
|---|---|
| Time of regression of signs and symptoms of sinusitis, rate of clinical relapse at follow-up visit.Bacteriological data.Safety data... | During all the study conduct |
Outcome results
None listed