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

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ClinicalTrials.gov Identifier: NCT02340000
Recruitment Status : Completed
First Posted : January 16, 2015
Results First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Paul Sorum, MD, Albany Medical College

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sinusitis
Interventions Drug: standard dose amoxicillin/clavulanate
Drug: high dose amoxicillin/clavulanate
Enrollment 315
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Dose High Dose
Hide Arm/Group Description

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

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

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

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

Period Title: Time Period 1
Started 90 89
Completed 78 74
Not Completed 12 15
Reason Not Completed
Withdrawal by Subject             6             8
Lost to Follow-up             6             7
Period Title: Time Period 2
Started 69 67
Completed 50 52
Not Completed 19 15
Reason Not Completed
Withdrawal by Subject             9             7
Lost to Follow-up             10             8
Arm/Group Title Standard Dose High Dose Total
Hide Arm/Group Description

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

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 159 156 315
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 159 participants 156 participants 315 participants
48.0  (15.9) 45.9  (14.8) 46.9  (15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 156 participants 315 participants
Female
115
  72.3%
108
  69.2%
223
  70.8%
Male
44
  27.7%
48
  30.8%
92
  29.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Active tobacco use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 156 participants 315 participants
19
  11.9%
20
  12.8%
39
  12.4%
COPD/asthma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 156 participants 315 participants
29
  18.2%
30
  19.2%
59
  18.7%
allergic rhinitis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 156 participants 315 participants
82
  51.6%
80
  51.3%
162
  51.4%
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 156 participants 315 participants
16
  10.1%
15
   9.6%
31
   9.8%
Heart disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 156 participants 315 participants
11
   6.9%
8
   5.1%
19
   6.0%
History of sinusitis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 156 participants 315 participants
63
  39.6%
60
  38.5%
123
  39.0%
Days of illness   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 159 participants 156 participants 315 participants
14.8  (8.8) 14.3  (8.1) 14.5  (8.4)
[1]
Measure Description: Clinician indicated the number of days the patient had been sick prior to the office visit.
Sinusitis category 1   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 156 participants 315 participants
101
  63.5%
103
  66.0%
204
  64.8%
[1]
Measure Description: Duration greater than or equal to 10 days
Sinusitis category 2   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 156 participants 315 participants
18
  11.3%
19
  12.2%
37
  11.7%
[1]
Measure Description: Severe symptoms (most severe of the 3 categories)
Sinusitis category 3   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 156 participants 315 participants
40
  25.2%
34
  21.8%
74
  23.5%
[1]
Measure Description: double sickening
Day 0 SNOT-16 mean item score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 159 participants 156 participants 315 participants
1.89  (.56) 1.99  (.55) 1.94  (.55)
[1]
Measure Description: 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)
1.Primary Outcome
Title Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")
Hide Description rating of "a lot better" or "no symptoms"
Time Frame end of 3 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who gave ratings at the end of day 3 of treatment
Arm/Group Title Standard Dose Time Period I High Dose Time Period 1 Standard Dose Time Period 2 High Dose Time Period 2
Hide Arm/Group Description:

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

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

extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
Amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
Overall Number of Participants Analyzed 87 80 64 63
Measure Type: Count of Participants
Unit of Measure: Participants
33
  37.9%
31
  38.8%
22
  34.4%
33
  52.4%
2.Secondary Outcome
Title SNOT-16 - Day 3
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who gave ratings at day 3.
Arm/Group Title Standard Dose Time Period I High Dose Time Period 1 Standard Dose Time Period 2 High Dose Time Period 2
Hide Arm/Group Description:
amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
Overall Number of Participants Analyzed 86 80 62 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
.75  (.63) .87  (.59) .91  (.63) .97  (.69)
3.Secondary Outcome
Title Subjective Improvement - Day 10
Hide Description rating of "a lot better" or "no symptoms"
Time Frame end of 10th day
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who gave a rating at day 10.
Arm/Group Title Standard Dose Time Period I High Dose Time Period 1 Standard Dose Time Period 2 High Dose Time Period 2
Hide Arm/Group Description:
amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
Overall Number of Participants Analyzed 78 74 50 52
Measure Type: Count of Participants
Unit of Measure: Participants
63
  80.8%
59
  79.7%
35
  70.0%
40
  76.9%
4.Secondary Outcome
Title SNOT-16 - Day 10
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who gave ratings at day 10.
Arm/Group Title Standard Dose Time Period I High Dose Time Period 1 Standard Dose Time Period 2 High Dose Time Period 2
Hide Arm/Group Description:
amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
Overall Number of Participants Analyzed 79 75 51 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.32  (.71) 1.48  (.64) 1.37  (.67) 1.40  (.73)
5.Secondary Outcome
Title Nasal Colonization With Resistant Bacteria
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All 231 participants were analyzed together regardless of treatment.
Arm/Group Title Overall
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First 231 participants
Overall Number of Participants Analyzed 231
Measure Type: Count of Participants
Unit of Measure: Participants
No growth or normal flora
139
  60.2%
Methicillin-sensitive Staphylococcus aureus
32
  13.9%
Haemophilus influenzae
25
  10.8%
Streptococcus pneumoniae
9
   3.9%
Moxarella catarrhalis
9
   3.9%
Staphylococcus epidermidis
7
   3.0%
Methicillin-resistant Staphylococcus aureus
5
   2.2%
6.Secondary Outcome
Title Willingness to Take the Study Antibiotic in the Future
Hide Description whether participants said they would NOT take the antibiotic again
Time Frame end of 10th day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Dose Time Period I High Dose Time Period 1 Standard Dose Time Period 2 High Dose Time Period 2
Hide Arm/Group Description:
amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
Overall Number of Participants Analyzed 75 74 49 52
Measure Type: Count of Participants
Unit of Measure: Participants
8
  10.7%
11
  14.9%
5
  10.2%
8
  15.4%
Time Frame 10 days
Adverse Event Reporting Description The number of participants reporting adverse effects was less than the number initially at risk because some patients withdrew before starting treatment or were lost to follow-up for the study. Since they were all patients in our practice, however, we knew--outside of the study---that none of them suffered death or other serious adverse effects.
 
Arm/Group Title Standard Dose Time Period I High Dose Time Period 1 Standard Dose Time Period 2 High Dose Time Period 2
Hide Arm/Group Description amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days amoxicillin/clavulnate 875/125 plus placebo bid x 7 days immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
All-Cause Mortality
Standard Dose Time Period I High Dose Time Period 1 Standard Dose Time Period 2 High Dose Time Period 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/90 (0.00%)      0/89 (0.00%)      0/69 (0.00%)      0/67 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Standard Dose Time Period I High Dose Time Period 1 Standard Dose Time Period 2 High Dose Time Period 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/90 (0.00%)      0/89 (0.00%)      0/69 (0.00%)      0/67 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Dose Time Period I High Dose Time Period 1 Standard Dose Time Period 2 High Dose Time Period 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/87 (34.48%)      37/80 (46.25%)      19/62 (30.65%)      27/57 (47.37%)    
Gastrointestinal disorders         
diarrhea  [1]  30/87 (34.48%)  30 37/80 (46.25%)  37 19/62 (30.65%)  19 27/57 (47.37%)  27
Infections and infestations         
Vaginitis  [2]  3/87 (3.45%)  3 11/80 (13.75%)  11 4/62 (6.45%)  4 7/57 (12.28%)  7
Indicates events were collected by systematic assessment
[1]
diarrhea at day 3
[2]
vaginal itching or discharge at day 3
  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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Paul Sorum, MD
Organization: Albany Medical College
Phone: 5182627500
Responsible Party: Paul Sorum, MD, Albany Medical College
ClinicalTrials.gov Identifier: NCT02340000     History of Changes
Other Study ID Numbers: 3968
First Submitted: November 22, 2014
First Posted: January 16, 2015
Results First Submitted: July 16, 2017
Results First Posted: August 24, 2017
Last Update Posted: August 24, 2017