NCT00245440

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

Influence of Oral Telithromycin vs. Azithromycin on the Endogenous Microflora in Adults With Acute Sinusitis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: CPL Associates · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Maxillary Sinusitis

Interventions

Type	Name	Description
DRUG	Azithromycin	250 mg tablets; 2 tablets once daily (500 mg) for 3 days
DRUG	Telithromycin	400 mg tablets; 2 tablets once daily (800 mg) for 5 days

Timeline

• Start date: 2005-12-01
• Completion: 2006-07-01
• First posted: 2005-10-28
• Last updated: 2007-10-31

Locations

1 site across 1 country: United States