Status:
TERMINATED
Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate
Lead Sponsor:
Paul Sorum, MD
Conditions:
Sinusitis, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Comparative-effectiveness study of the treatment of acute bacterial sinusitis with amoxicillin/clavulanate 875mg/125mg bid for 7 days with or without the addition of immediate-release amoxicillin 875 ...
Detailed Description
Double-blind comparative-effectiveness study of the treatment of acute bacterial sinusitis with standard dose of amoxicillin/clavulanate 875mg/125mg bid for 7 days, as recommended by the Infectious Di...
Eligibility Criteria
Inclusion
- Adults 18 and older who are patients at the Albany Medical Center Internal Medicine and Pediatrics practice (study site).
- Clinical diagnosis of acute bacterial sinusitis in accordance with the guidelines of the Infectious Disease Society of America (fitting into one of 3 categories: persistent sinus symptoms for 10 days or more; severe sinus symptoms for 3 days or more; or worsening sinus symptoms after initial improvement (double sickening).
Exclusion
- Previous enrollment in the current study
- Allergy or intolerance to any penicillin or to amoxicillin/clavulanate
- Serious hypersensitivity reaction to any beta lactam
- Elevated risk of amoxicillin-resistant bacteria: a. amoxicillin, penicillin, or other beta-lactam within the past month; b. known to have had methicillin-resistant Staph aureus
- Chronic or recurrent "sinus" problems (defined as a) persistent symptoms of "sinus" congestion, not attributed to nasal allergies, for 8 weeks or more or b) 2 or more episodes of antibiotic-treated "sinusitis" in past 3 months
- Need to use high-dose amoxicillin/clavulanate or levofloxacin or to send to emergency department or to hospitalize because of a) signs of severe infection or b) immunocompromise
- Cognitive impairment, so unable to give reliable symptom ratings (even if a health proxy can give consent)
- Pregnant women and nursing mothers
- Drug warnings: a) taking allopurinol; b) current mononucleosis; c) chronic kidney disease stage 4 (estimated glomerular filtration rate \<30); d) hepatic impairment (not including isolated transaminase elevated \< 2 times upper limit of normal); e) history of antibiotic-associated colitis (C. difficile)
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT03431337
Start Date
February 26 2018
End Date
May 31 2020
Last Update
August 12 2021
Active Locations (1)
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1
Albany Medical Center Internal Medicine and Pediatrics
Cohoes, New York, United States, 12047