Clinical trial NCT02340000: Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
Official title: Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sinusitis
Keywords: acute sinusitis
amoxicillin/clavulanate
adults
outcomes
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")
timeFrame: end of 3 days of treatment
Secondary outcomes:
measure: SNOT-16 - Day 3
timeFrame: day 0, end of 3 days of treatment
measure: Subjective Improvement - Day 10
timeFrame: end of 10th day
measure: SNOT-16 - Day 10
timeFrame: day 0, end of 10th day
measure: Nasal Colonization With Resistant Bacteria
timeFrame: baseline
measure: Willingness to Take the Study Antibiotic in the Future
timeFrame: end of 10th day
Other outcomes:
Locations:
city: Latham
country: United States
facility: Albany Medical Center Internal Medicine and Pediatrics
state: New York
Study officials:
References:
citation: Chow AW, Benninger MS, Brook I, Brozek JL, Goldstein EJ, Hicks LA, Pankey GA, Seleznick M, Volturo G, Wald ER, File TM Jr; Infectious Diseases Society of America. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012 Apr;54(8):e72-e112. doi: 10.1093/cid/cir1043. Epub 2012 Mar 20.
citation: Matho A, Mulqueen M, Tanino M, Quidort A, Cheung J, Pollard J, Rodriguez J, Swamy S, Tayler B, Garrison G, Ata A, Sorum P. High-dose versus standard-dose amoxicillin/clavulanate for clinically-diagnosed acute bacterial sinusitis: A randomized clinical trial. PLoS One. 2018 May 8;13(5):e0196734. doi: 10.1371/journal.pone.0196734. eCollection 2018.