Study to Measure the Impact of Antibiotics on Bacterial Flora in Adults With Acute Sinusitis

• Status: Terminated
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to measure the speed of microbial eradication due to azithromycin or telithromycin in acute maxillary sinusitis (AMS).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CPL Associates
• Collaborator: Sanofi
• Treatments: Azithromycin; Telithromycin

Criteria

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.