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

This study has been terminated.
(Sponsor Terminated)
Information provided by:
CPL Associates Identifier:
First received: October 26, 2005
Last updated: October 29, 2007
Last verified: October 2007
The purpose of this study is to measure the speed of microbial eradication due to azithromycin or telithromycin in acute maxillary sinusitis (AMS).

Condition Intervention Phase
Maxillary Sinusitis
Drug: Azithromycin
Drug: Telithromycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Influence of Oral Telithromycin vs. Azithromycin on the Endogenous Microflora in Adults With Acute Sinusitis

Resource links provided by NLM:

Further study details as provided by CPL Associates:

Primary Outcome Measures:
  • Bacterial resistance or selection [ Time Frame: 42 days ]

Secondary Outcome Measures:
  • Bacteriologic outcome [ Time Frame: 42 days ]

Enrollment: 192
Study Start Date: December 2005
Study Completion Date: July 2006
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00245440

United States, South Carolina
Southeastern Researchs Associates,Inc.
Taylors, South Carolina, United States, 29687
Sponsors and Collaborators
CPL Associates
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
  More Information

Additional Information: Identifier: NCT00245440     History of Changes
Other Study ID Numbers: HMR3647A-6045
Study First Received: October 26, 2005
Last Updated: October 29, 2007

Keywords provided by CPL Associates:

Additional relevant MeSH terms:
Maxillary Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents processed this record on April 21, 2017