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

Maxillary Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00245440
• Other study ID #: HMR3647A-6045
• Status: Terminated
• Phase: Phase 4
• First received: October 26, 2005
• Last updated: October 29, 2007
• Start date: December 2005
• Est. completion date: July 2006

Study information

• Verified date: October 2007
• Source: CPL Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 192
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Maxillary Sinusitis
• Sinusitis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Southeastern Researchs Associates,Inc.	Taylors	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
CPL Associates	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial resistance or selection		42 days
Secondary	Bacteriologic outcome		42 days

External Links

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