search
Back to results

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

Primary Purpose

Maxillary Sinusitis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Azithromycin
Telithromycin
Sponsored by
CPL Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Maxillary Sinusitis focused on measuring S.pneumonia, sinusitis, ams, azithromycin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Southeastern Researchs Associates,Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Subjects assigned Azithromycin

Subjects assigned Telithromycin

Outcomes

Primary Outcome Measures

Bacterial resistance or selection

Secondary Outcome Measures

Bacteriologic outcome

Full Information

First Posted
October 26, 2005
Last Updated
October 29, 2007
Sponsor
CPL Associates
Collaborators
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT00245440
Brief Title
Study to Measure the Impact of Antibiotics on Bacterial Flora in Adults With Acute Sinusitis
Official Title
Influence of Oral Telithromycin vs. Azithromycin on the Endogenous Microflora in Adults With Acute Sinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Terminated
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CPL Associates
Collaborators
Sanofi

4. Oversight

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Sinusitis
Keywords
S.pneumonia, sinusitis, ams, azithromycin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Subjects assigned Azithromycin
Arm Title
2
Arm Type
Active Comparator
Arm Description
Subjects assigned Telithromycin
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
250 mg tablets; 2 tablets once daily (500 mg) for 3 days
Intervention Type
Drug
Intervention Name(s)
Telithromycin
Intervention Description
400 mg tablets; 2 tablets once daily (800 mg) for 5 days
Primary Outcome Measure Information:
Title
Bacterial resistance or selection
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Bacteriologic outcome
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerome J Schentag, Pharm.D.
Organizational Affiliation
State University of NY at Buffalo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Paladino, Pharm.D.
Organizational Affiliation
State University of NY at Buffalo
Official's Role
Study Director
Facility Information:
Facility Name
Southeastern Researchs Associates,Inc.
City
Taylors
State/Province
South Carolina
ZIP/Postal Code
29687
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.cplassociates.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs