Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate



Status:Recruiting
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2014
End Date:May 2017

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The aim is to determine if high-dose amoxicillin/clavulanate is more effective than
standard-dose amoxicillin/clavulanate in treating acute bacterial sinusitis in adults seen
at a primary care office.


Inclusion Criteria:

1. Adult 18 or over

2. Meets definition of acute sinusitis by Infectious Disease Society of America (2012)

3. Clinician and participant chose to start antibiotic treatment

Exclusion Criteria:

1. Previously enrolled in the study

2. Allergic or intolerant to amoxicillin, penicillin, or amoxicillin/clavulanate

3. Specific medication concerns: lactating (since safety of clavulanate unknown); taking
allopurinol (increased risk of rash); concurrent mononucleosis (increased risk of
rash with amoxicillin); chronic kidney disease with glomerular filtration rate < 30;
significant hepatic impairment; history of antibiotic-associated colitis

4. Cognitive impairment so that unable to give informed consent or give reliable
assessment of improvement

5. Need to use high-dose amoxicillin/clavulanate: treatment with amoxicllin or
penicillin within the past month (risk of penicillin-resistant pneumococci), very ill
patient (though not ill enough to send to hospital); immunocompromise

6. Need to hospitalize the patient
We found this trial at
1
site
Latham, New York 12110
Principal Investigator: Paul Sorum, MD
Phone: 518-262-7500
?
mi
from
Latham, NY
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