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CompletedNCT02340000Updated Aug 24, 2017Results posted

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

A Phase 4 interventional study of standard dose amoxicillin/clavulanate and high dose amoxicillin/clavulanate in Sinusitis, sponsored by Albany Medical College. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-24.

Sponsored by Albany Medical College · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
315
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sinusitis

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Keywords

  • acute sinusitis
  • amoxicillin/clavulanate
  • adults
  • outcomes
03

In context

Sinusitis

415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.

This study's enrollment of 315 is above the median of 60 across 313 interventional studies indexed under Sinusitis.

Browse Sinusitis studies →

Lead sponsor

Albany Medical College is the lead sponsor of 80 studies on the registry; 14 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
315 participants (actual)

Study arms

  • Active comparator
    standard dose

    amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days

    Drug: standard dose amoxicillin/clavulanate

  • Experimental
    high dose

    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

    Drug: high dose amoxicillin/clavulanate

Interventions

  • Drugstandard dose amoxicillin/clavulanate

    amoxicillin/clavulanate 875/125 + placebo bid x 7 days

  • Drughigh 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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Subjective Improvement - Day 10

    rating of "a lot better" or "no symptoms"

    Time frame: end of 10th day

  3. 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

  4. 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

  5. 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

07

Results

Posted Aug 24, 2017
Limitations and caveats
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.

Participant flow

Time Period 1
Participant flow — Time Period 1
MilestoneStandard DoseHigh Dose
Started9089
Completed7874
Not completed1215
Withdrew: Withdrawal by subject68
Withdrew: Lost to follow-up67
Time Period 2
Participant flow — Time Period 2
MilestoneStandard DoseHigh Dose
Started6967
Completed5052
Not completed1915
Withdrew: Withdrawal by subject97
Withdrew: Lost to follow-up108

Outcome measures

PrimarySubjective 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
Reported as:
Count of participants · Participants
Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")
ParticipantsStandard Dose Time Period IHigh Dose Time Period 1Standard Dose Time Period 2High Dose Time Period 2
Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")33312233
SecondarySNOT-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
Reported as:
Mean · units on a scale
SNOT-16 - Day 3
units on a scaleStandard Dose Time Period IHigh Dose Time Period 1Standard Dose Time Period 2High Dose Time Period 2
SNOT-16 - Day 3.75 ± .63.87 ± .59.91 ± .63.97 ± .69
SecondarySubjective Improvement - Day 10

rating of "a lot better" or "no symptoms"

Time frame:
end of 10th day
Reported as:
Count of participants · Participants
Subjective Improvement - Day 10
ParticipantsStandard Dose Time Period IHigh Dose Time Period 1Standard Dose Time Period 2High Dose Time Period 2
Subjective Improvement - Day 1063593540
SecondarySNOT-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
Reported as:
Mean · units on a scale
SNOT-16 - Day 10
units on a scaleStandard Dose Time Period IHigh Dose Time Period 1Standard Dose Time Period 2High Dose Time Period 2
SNOT-16 - Day 101.32 ± .711.48 ± .641.37 ± .671.40 ± .73
SecondaryNasal 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
Reported as:
Count of participants · Participants
Nasal Colonization With Resistant Bacteria
ParticipantsOverall
No growth or normal flora139
Methicillin-sensitive Staphylococcus aureus32
Haemophilus influenzae25
Streptococcus pneumoniae9
Moxarella catarrhalis9
Staphylococcus epidermidis7
Methicillin-resistant Staphylococcus aureus5
SecondaryWillingness to Take the Study Antibiotic in the Future

whether participants said they would NOT take the antibiotic again

Time frame:
end of 10th day
Reported as:
Count of participants · Participants
Willingness to Take the Study Antibiotic in the Future
ParticipantsStandard Dose Time Period IHigh Dose Time Period 1Standard Dose Time Period 2High Dose Time Period 2
Willingness to Take the Study Antibiotic in the Future81158

Adverse events

Collected over 10 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Standard Dose Time Period I0/90 (0%)0/90 (0%)30/87 (34.5%)
High Dose Time Period 10/89 (0%)0/89 (0%)37/80 (46.3%)
Standard Dose Time Period 20/69 (0%)0/69 (0%)19/62 (30.6%)
High Dose Time Period 20/67 (0%)0/67 (0%)27/57 (47.4%)
Most frequent other events
Most frequent other events
EventStandard Dose Time Period IHigh Dose Time Period 1Standard Dose Time Period 2High Dose Time Period 2
diarrheaGastrointestinal disorders30/8737/8019/6227/57
VaginitisInfections and infestations3/8711/804/627/57

Baseline characteristics

Age, Continuous
Age, Continuous(years)Standard DoseHigh DoseTotal
Mean48.0 ± 15.945.9 ± 14.846.9 ± 15.4
Sex: Female, Male
Sex: Female, Male(Participants)Standard DoseHigh DoseTotal
Female115108223
Male444892
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Standard DoseHigh DoseTotal
Count of participants——0
Active tobacco use
Active tobacco use(Participants)Standard DoseHigh DoseTotal
Count of participants192039
COPD/asthma
COPD/asthma(Participants)Standard DoseHigh DoseTotal
Count of participants293059
allergic rhinitis
allergic rhinitis(Participants)Standard DoseHigh DoseTotal
Count of participants8280162
Diabetes
Diabetes(Participants)Standard DoseHigh DoseTotal
Count of participants161531
Heart disease
Heart disease(Participants)Standard DoseHigh DoseTotal
Count of participants11819

6 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Albany Medical Center Internal Medicine and Pediatrics
    Latham, New York 12110, United States
09

References and documents

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 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 14, 2014
  • Informed consent form · Sep 28, 2014

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02340000
Lead sponsor
Albany Medical College
Responsible party
Paul Sorum, MD (Professor of Internal Medicine and Pediatrics, Albany Medical College) — Principal investigator
First posted
Jan 16, 2015
Start date
Nov 18, 2014
Primary completion
Feb 27, 2017
Completion
Feb 27, 2017
Results posted
Aug 24, 2017
Last update
Aug 24, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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