Study to Measure the Impact of Antibiotics on Bacterial Flora in Adults With Acute Sinusitis
NCT ID: NCT00245440
Last Updated: 2007-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
192 participants
INTERVENTIONAL
2005-12-31
2006-07-31
Brief Summary
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Detailed Description
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* 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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1
Subjects assigned Azithromycin
Azithromycin
250 mg tablets; 2 tablets once daily (500 mg) for 3 days
2
Subjects assigned Telithromycin
Telithromycin
400 mg tablets; 2 tablets once daily (800 mg) for 5 days
Interventions
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Azithromycin
250 mg tablets; 2 tablets once daily (500 mg) for 3 days
Telithromycin
400 mg tablets; 2 tablets once daily (800 mg) for 5 days
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
CPL Associates
OTHER
Principal Investigators
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Jerome J Schentag, Pharm.D.
Role: PRINCIPAL_INVESTIGATOR
State University of NY at Buffalo
Joseph Paladino, Pharm.D.
Role: STUDY_DIRECTOR
State University of NY at Buffalo
Locations
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Southeastern Researchs Associates,Inc.
Taylors, South Carolina, United States
Countries
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Related Links
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Related Info
Other Identifiers
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HMR3647A-6045
Identifier Type: -
Identifier Source: org_study_id