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

Phase 4

Completed

• Conditions: Sinusitis
• Interventions: Drug: standard dose amoxicillin/clavulanate; Drug: high dose amoxicillin/clavulanate

• Registration Number: NCT02340000
• Lead Sponsor: Albany Medical College

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.

Study Timeline

• Study Start: 2014-11-18
• Study First Submitted: 2014-11-22
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-16
• Primary Completion: 2017-02-27
• Study Completion: 2017-02-27
• Results First Submitted: 2017-07-16
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-22
• Last Update Submitted: 2017-08-22
• Results First Posted: 2017-08-24
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard dose	standard dose amoxicillin/clavulanate	amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
high dose	high dose amoxicillin/clavulanate	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

Primary Outcome Measures

Name	Time	Method
Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")	end of 3 days of treatment	rating of "a lot better" or "no symptoms"

Secondary Outcome Measures

Name	Time	Method
SNOT-16 - Day 3	day 0, end of 3 days of treatment	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).
Subjective Improvement - Day 10	end of 10th day	rating of "a lot better" or "no symptoms"
SNOT-16 - Day 10	day 0, end of 10th day	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).
Nasal Colonization With Resistant Bacteria	baseline	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).
Willingness to Take the Study Antibiotic in the Future	end of 10th day	whether participants said they would NOT take the antibiotic again

Trial Locations

Locations (1)

Albany Medical Center Internal Medicine and Pediatrics; 🇺🇸 Latham, New York, United States