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

Albany Medical College

Status and phase: Completed; Phase 4

Conditions: Sinusitis

Treatments: Drug: high dose amoxicillin/clavulanate; Drug: standard dose amoxicillin/clavulanate

Study type: Interventional

Funder types: Other

Identifiers

NCT02340000

3968

Details and patient eligibility

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.

Full description

The aim was amended in February 2016--because of the unexpected unavailability of the original high-dose formulation of amoxicillin/clavulanate--to compare the effectiveness (versus standard dose) of extended-release (the original formulation) versus immediate-release amoxicillin/clavulanate.

Enrollment: 315 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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315 participants in 2 patient groups

standard dose

Active Comparator group

Description:

amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days

Treatment:

Drug: standard dose amoxicillin/clavulanate

high dose

Experimental group

Description:

Time Period I (November 18, 2014-January 5, 2016): extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets (by different manufacturer) twice a day for 7 days Time Period 2 (February 6, 2016-February 27, 2017): immediate-release amoxicillin/clavunate 875/125 mg plus standard immediate-release amoxicillin 875 mg twice a day for 7 days

Treatment:

Drug: high dose amoxicillin/clavulanate