Study to Measure the Impact of Antibiotics on Bacterial Flora in Adults With Acute Sinusitis
Stopped early · Phase 4
Conditions studied: Maxillary Sinusitis
In brief
The purpose of this study is to measure the speed of microbial eradication due to azithromycin or telithromycin in acute maxillary sinusitis (AMS).
Key facts
- Study ID
- NCT00245440
- Run by
- CPL Associates
- People needed
- 192
- Starts
- 2005-12-01
- Expected to finish
- 2006-07-01
- Last updated by the study team
- 2007-10-31
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Southeastern Researchs Associates,Inc. — Taylors, South Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.