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

Sponsor

CPL Associates (Other)

Overall Status

Terminated

CT.gov ID

NCT00245440

Collaborator

Sanofi (Industry)

192

Enrollment

Location

Arms

Duration (Months)

27.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Maxillary Sinusitis	Drug: Azithromycin Drug: Telithromycin	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Dec 1, 2005

Actual Study Completion Date :

Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Subjects assigned Azithromycin	Drug: Azithromycin 250 mg tablets; 2 tablets once daily (500 mg) for 3 days
Active Comparator: 2 Subjects assigned Telithromycin	Drug: Telithromycin 400 mg tablets; 2 tablets once daily (800 mg) for 5 days

Arm

Intervention/Treatment

Active Comparator: 1

Subjects assigned Azithromycin

Drug: Azithromycin

250 mg tablets; 2 tablets once daily (500 mg) for 3 days

Active Comparator: 2

Subjects assigned Telithromycin

Drug: Telithromycin

400 mg tablets; 2 tablets once daily (800 mg) for 5 days

Outcome Measures

Primary Outcome Measures

Bacterial resistance or selection [42 days]

Secondary Outcome Measures

Bacteriologic outcome [42 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southeastern Researchs Associates,Inc.	Taylors	South Carolina	United States	29687

Sponsors and Collaborators

CPL Associates
Sanofi

Investigators

Principal Investigator: Jerome J Schentag, Pharm.D., State University of NY at Buffalo
Study Director: Joseph Paladino, Pharm.D., State University of NY at Buffalo