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

Completed · Phase 4 · Has a placebo group

Conditions studied: Sinusitis

In brief

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.

Key facts

Study ID

NCT02340000

Run by

Albany Medical College

People needed

315

Starts

2014-11-18

Expected to finish

2017-02-27

Last updated by the study team

2017-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult 18 or over
• Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
• Clinician and participant chose to start antibiotic treatment

You may not qualify if…

• Previously enrolled in the study
• Allergic or intolerant to amoxicillin, penicillin, or amoxicillin/clavulanate
• 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
• Cognitive impairment so that unable to give informed consent or give reliable assessment of improvement
• 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
• Need to hospitalize the patient

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.