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 |
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.
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
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