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

October 29, 2007 updated by: CPL Associates

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Taylors, South Carolina, United States, 29687
        • Southeastern Researchs Associates,Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bacterial resistance or selection
Time Frame: 42 days
42 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Bacteriologic outcome
Time Frame: 42 days
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CPL Associates

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

October 26, 2005

First Submitted That Met QC Criteria

October 26, 2005

First Posted (Estimate)

October 28, 2005

Study Record Updates

Last Update Posted (Estimate)

October 31, 2007

Last Update Submitted That Met QC Criteria

October 29, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMR3647A-6045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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