Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Sinusitis, Acute

In brief

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 mg bid x 7 days. .

Key facts

Study ID

NCT03431337

Run by

Paul Sorum, MD

People needed

157

Starts

2018-02-26

Expected to finish

2020-05-31

Last updated by the study team

2021-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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)

Where it is running

• Albany Medical Center Internal Medicine and Pediatrics — Cohoes, New York, United States

Full record on ClinicalTrials.gov

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