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

Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340000
• Other study ID #: 3968
• Status: Completed
• Phase: Phase 4
• First received: November 22, 2014
• Last updated: August 22, 2017
• Start date: November 18, 2014
• Est. completion date: February 27, 2017

Study information

• Verified date: August 2017
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: February 27, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sinusitis

Intervention

Drug:
• standard dose amoxicillin/clavulanate
amoxicillin/clavulanate 875/125 + placebo bid x 7 days
• high dose amoxicillin/clavulanate
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

Locations

Country	Name	City	State
United States	Albany Medical Center Internal Medicine and Pediatrics	Latham	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")	rating of "a lot better" or "no symptoms"	end of 3 days of treatment
Secondary	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).	day 0, end of 3 days of treatment
Secondary	Subjective Improvement - Day 10	rating of "a lot better" or "no symptoms"	end of 10th day
Secondary	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).	day 0, end of 10th day
Secondary	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).	baseline
Secondary	Willingness to Take the Study Antibiotic in the Future	whether participants said they would NOT take the antibiotic again	end of 10th day