Status:
TERMINATED
Study to Measure the Impact of Antibiotics on Bacterial Flora in Adults With Acute Sinusitis
Lead Sponsor:
CPL Associates
Collaborating Sponsors:
Sanofi
Conditions:
Maxillary Sinusitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00245440
Start Date
December 1 2005
End Date
July 1 2006
Last Update
October 31 2007
Active Locations (1)
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1
Southeastern Researchs Associates,Inc.
Taylors, South Carolina, United States, 29687