SinusitisPhase 4NCT02340000

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

A Phase 4 study testing standard dose amoxicillin/clavulanate and high dose amoxicillin/clavulanate in people with Sinusitis, run by Albany Medical College at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Sinusitis
What is being tested?: standard dose amoxicillin/clavulanate and high dose amoxicillin/clavulanate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 315 participants
Where: 1 siteUnited States
Study dates: 18 Nov 2014to 27 Feb 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult 18 or over
Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
Clinician and participant chose to start antibiotic treatment

Who cannot join

Previously enrolled in the study
Allergic or intolerant to amoxicillin, penicillin, or amoxicillin/clavulanate
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
Cognitive impairment so that unable to give informed consent or give reliable assessment of improvement
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
Need to hospitalize the patient

Trial locations and contacts

1 site in 1 country.

United States1 site

Albany Medical Center Internal Medicine and Pediatrics
Latham, New York, 12110

Other trials in United States

About this study

Read the 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.

Conditions: Sinusitis
Being tested: standard dose amoxicillin/clavulanate, high dose amoxicillin/clavulanate
Keywords: acute sinusitis, amoxicillin/clavulanate, adults, outcomes
Medical subject headings: Sinusitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

standard dose amoxicillin/clavulanateDrug
amoxicillin/clavulanate 875/125 + placebo bid x 7 days
high dose amoxicillin/clavulanateDrug
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

Study groups in NCT02340000
Study group	Role	What they receive
standard dose	Active comparator	amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days Receives: Drug: standard dose amoxicillin/clavulanate
high dose	Experimental	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 Receives: Drug: high dose amoxicillin/clavulanate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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).
Measured: day 0, end of 3 days of treatment
Subjective Improvement - Day 10
rating of "a lot better" or "no symptoms"
Measured: 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).
Measured: 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).
Measured: baseline
Willingness to Take the Study Antibiotic in the Future
whether participants said they would NOT take the antibiotic again
Measured: end of 10th day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 201427 Feb 2017

First posted16 Jan 2015 (estimated)
Study start18 Nov 2014
Primary completion27 Feb 2017
Study completion27 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SinusitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 315 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02340000
Sponsor's protocol ID: 3968
Status last verified: Aug 2017
First submitted: 22 Nov 2014
Last updated: 24 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 22438350
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.
PubMed 29738561

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
ACUTE SINUSITIS, Sinusitis

All Sinusitis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
ClinicalTrials.gov ID: NCT02340000
Acronym / sponsor ID: 3968
Conditions: Sinusitis
Keywords: acute sinusitis, amoxicillin/clavulanate, adults, outcomes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 315 participants (actual)
Lead sponsor: Albany Medical CollegeUniversity, hospital or other
Study start: 18 Nov 2014 (actual)
Primary completion: 27 Feb 2017 (actual)
Study completion: 27 Feb 2017 (actual)
First posted: 16 Jan 2015 (estimated)
Results: Posted 24 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
standard dose	Active comparator	Drug: standard dose amoxicillin/clavulanateamoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
high dose	Experimental	Drug: high dose amoxicillin/clavulanateTime 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adult 18 or over
Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
Clinician and participant chose to start antibiotic treatment

Key exclusion criteria (6 listed)

Previously enrolled in the study
Allergic or intolerant to amoxicillin, penicillin, or amoxicillin/clavulanate
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
Cognitive impairment so that unable to give informed consent or give reliable assessment of improvement
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
standard dose amoxicillin/clavulanateamoxicillin/clavulanate 875/125 + placebo bid x 7 days	Drug	standard dose
high dose amoxicillin/clavulanateTime 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	Drug	high dose

Primary outcome

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

5 secondary outcomes

SNOT-16 - Day 3
Time frame: day 0, end of 3 days of treatment
Subjective Improvement - Day 10
Time frame: end of 10th day
SNOT-16 - Day 10
Time frame: day 0, end of 10th day
Nasal Colonization With Resistant Bacteria
Time frame: baseline
Willingness to Take the Study Antibiotic in the Future
Time frame: end of 10th day

Results and safety

Results posted to the registry on 24 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Dose	90	78
High Dose	89	74

Primary outcome: Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")

Time frame: end of 3 days of treatment. Count of participants. Unit: Participants

Measure	Standard Dose Time Period I n = 87	High Dose Time Period 1 n = 80	Standard Dose Time Period 2 n = 64	High Dose Time Period 2 n = 63
Value	33	31	22	33

Population analysed: The number of participants who gave ratings at the end of day 3 of treatment

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Dose Time Period I	0 of 90 (0%)	30 of 87 (34.5%)	0 of 90
High Dose Time Period 1	0 of 89 (0%)	37 of 80 (46.3%)	0 of 89
Standard Dose Time Period 2	0 of 69 (0%)	19 of 62 (30.6%)	0 of 69
High Dose Time Period 2	0 of 67 (0%)	27 of 57 (47.4%)	0 of 67

Limitations and caveats (from the sponsor): 1. Initial formulation of high-dose amox/clav (extended release) became unavailable, so had to switch after participant #180 to immediate-release. 2. The medical students and residents had trouble reaching some participants for follow-up.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22438350Chow 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.
Derived from this study: PubMed 29738561Matho 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.
Individual participant dataSharing planned: No

Related trials for Sinusitis

RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
ACUTE SINUSITIS, Sinusitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing standard dose amoxicillin/clavulanate and high dose amoxicillin/clavulanate in people with Sinusitis, run by Albany Medical College at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms") (time frame: end of 3 days of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02340000, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.