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Sinusitis

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

Sponsored by Albany Medical College

About this trial

Last updated 8 years ago

Study ID

3968

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 8 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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