Maxillary Sinusitis
Conditions
Keywords
S.pneumonia, sinusitis, ams, azithromycin
Brief summary
The purpose of this study is to measure the speed of microbial eradication due to azithromycin or telithromycin in acute maxillary sinusitis (AMS).
Detailed description
The objectives of this study are: * To assess the impact of therapy with telithromycin vs. azithromycin on the oral microflora in patients with acute maxillary sinusitis at day 42 and to compare the duration of colonization with resistant oropharyngeal flora in patients treated with azithromycin vs. telithromycin. * To also compare the two treatment groups for rate of reinfection within 6 weeks and the susceptibility pattern of the organisms appearing during the reinfection and differences in development of resistance and the associated changes in symptom responses.
Interventions
DRUGAzithromycin
250 mg tablets; 2 tablets once daily (500 mg) for 3 days
DRUGTelithromycin
400 mg tablets; 2 tablets once daily (800 mg) for 5 days
Sponsors
Sanofi
CPL Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients, either males or non-pregnant females, aged 18 to 75 years of age with clinical findings of acute maxillary sinusitis (AMS), who are amenable to serial sampling of the nasopharynx and oropharynx. * Patients are required to have specimens of nasal and nasopharyngeal drainage collected for microbiological documentation within 24 hours prior to enrollment. All patients must produce sinus fluid drainage. * All patients will produce nasal or nasopharyngeal discharge sufficient for baseline culture. * Female patients of child bearing potential must agree to use an accepted method of contraception (i.e., oral or implanted contraceptive with a barrier method, spermicide and barrier methods, or intrauterine device \[IUD\]). The patient must agree to continue with the same method throughout the study.
Exclusion criteria
* Patients with a history of recurrent sinusitis defined as more than three episodes of sinusitis which required antibiotic therapy in the preceding 12 months * Patients with a history of chronic sinusitis defined as symptoms lasting greater than 28 days * Patients with nosocomial acquired sinusitis (e.g., hospitalization or non-ambulatory institutional confinement including nursing homes within 2 weeks) * Patients with a need for immediate surgery for maxillary sinusitis or previous sinus surgery within the past 6 months or sinus lavage within the past 7 days * Patients who are long-term (\> 4 weeks) users of nasal decongestants (e.g. oxymetazoline 0.05%) * Patients with a known or suspected hypersensitivity to, or a known or suspected serious adverse reaction to, any macrolide antibiotic * Impaired hepatic or renal function (creatinine clearance \[CCL\] \<20 ml/min) * Severe respiratory tract infections requiring hospitalization and parenteral antibiotic therapy. * Requirement for a concomitant antimicrobial agent other than topical, antiviral or antifungal agents. * Treatment with any macrolide, azalide, or ketolide antimicrobial within the 30 days prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacterial resistance or selection | 42 days |
Secondary
| Measure | Time frame |
|---|---|
| Bacteriologic outcome | 42 days |
Countries
United States
Outcome results
None listed