Study to Measure the Impact of Antibiotics on Bacterial Flora in Adults With Acute Sinusitis
This study has been terminated.
(Sponsor Terminated)
Sponsor:
CPL Associates
Collaborator:
Sanofi
Information provided by:
CPL Associates
ClinicalTrials.gov Identifier:
NCT00245440
First received: October 26, 2005
Last updated: October 29, 2007
Last verified: October 2007
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Purpose
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 Endpoint Classification: Pharmacodynamics Study 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:
MedlinePlus related topics:
Sinusitis
Drug Information available for:
Azithromycin
Azithromycin dihydrate
Azithromycin monohydrate
Telithromycin
U.S. FDA Resources
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245440
Locations
| United States, South Carolina | |
| Southeastern Researchs Associates,Inc. | |
| Taylors, South Carolina, United States, 29687 | |
Sponsors and Collaborators
CPL Associates
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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00245440 History of Changes |
| Other Study ID Numbers: | HMR3647A-6045 |
| Study First Received: | October 26, 2005 |
| Last Updated: | October 29, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by CPL Associates:
|
S.pneumonia sinusitis ams azithromycin |
Additional relevant MeSH terms:
|
Maxillary Sinusitis Sinusitis Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
Azithromycin Telithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013