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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
315
amoxicillin/clavulanate 875/125 + placebo bid x 7 days
Time Period I: extended-release amoxicillin/clavulanate 1000/62.5 two tablets bid x 7 days Time Period 2: immediate-release amoxicillin/clavulanate 875/125 plus amoxicllin 875 bid x 7 days
Albany Medical Center Internal Medicine and Pediatrics
Latham, New York, United States
Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")
rating of "a lot better" or "no symptoms"
Time frame: end of 3 days of treatment
SNOT-16 - Day 3
Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms. The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 3 (values at day 0 minus values at day 3).
Time frame: day 0, end of 3 days of treatment
Subjective Improvement - Day 10
rating of "a lot better" or "no symptoms"
Time frame: end of 10th day
SNOT-16 - Day 10
Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms. The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 10 (values at day 0 minus values at day 10).
Time frame: day 0, end of 10th day
Nasal Colonization With Resistant Bacteria
Clinicians performed anterior nasal cultures to look for colonization with penicillin-resistant pneumococci and other pathogens (stopped after participant #231 because of lack of funds).
Time frame: baseline
Willingness to Take the Study Antibiotic in the Future
whether participants said they would NOT take the antibiotic again
Time frame: end of 10th day
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