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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00245440
Recruitment Status : Terminated (Sponsor Terminated)
First Posted : October 28, 2005
Last Update Posted : October 31, 2007
Information provided by:
CPL Associates

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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2005
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00245440

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United States, South Carolina
Southeastern Researchs Associates,Inc.
Taylors, South Carolina, United States, 29687
Sponsors and Collaborators
CPL Associates
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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
Additional Information:
Layout table for additonal information Identifier: NCT00245440    
Other Study ID Numbers: HMR3647A-6045
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007
Keywords provided by CPL Associates:
Additional relevant MeSH terms:
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Maxillary Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents