Clinical trial NCT00245440: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Maxillary Sinusitis
Keywords: S.pneumonia
sinusitis
ams
azithromycin
Lead sponsor: CPL Associates
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-10-28
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Bacterial resistance or selection
timeFrame: 42 days
Secondary outcomes:
measure: Bacteriologic outcome
timeFrame: 42 days
Other outcomes:
Locations:
city: Taylors
country: United States
facility: Southeastern Researchs Associates,Inc.
state: South Carolina
Study officials:
affiliation: State University of NY at Buffalo
name: Jerome J Schentag, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of NY at Buffalo
name: Joseph Paladino, Pharm.D.
role: STUDY_DIRECTOR
References: