Trial Outcomes & Findings for Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate (NCT NCT02340000)
NCT ID: NCT02340000
Last Updated: 2017-08-24
Results Overview
rating of "a lot better" or "no symptoms"
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
315 participants
Primary outcome timeframe
end of 3 days of treatment
Results posted on
2017-08-24
Participant Flow
Participant milestones
| Measure |
Standard Dose
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
|
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
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
|
|---|---|---|
|
Time Period 1
STARTED
|
90
|
89
|
|
Time Period 1
COMPLETED
|
78
|
74
|
|
Time Period 1
NOT COMPLETED
|
12
|
15
|
|
Time Period 2
STARTED
|
69
|
67
|
|
Time Period 2
COMPLETED
|
50
|
52
|
|
Time Period 2
NOT COMPLETED
|
19
|
15
|
Reasons for withdrawal
| Measure |
Standard Dose
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
|
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
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
|
|---|---|---|
|
Time Period 1
Withdrawal by Subject
|
6
|
8
|
|
Time Period 1
Lost to Follow-up
|
6
|
7
|
|
Time Period 2
Withdrawal by Subject
|
9
|
7
|
|
Time Period 2
Lost to Follow-up
|
10
|
8
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Dose
n=159 Participants
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
|
High Dose
n=156 Participants
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
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 15.9 • n=159 Participants
|
45.9 years
STANDARD_DEVIATION 14.8 • n=156 Participants
|
46.9 years
STANDARD_DEVIATION 15.4 • n=315 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=159 Participants
|
108 Participants
n=156 Participants
|
223 Participants
n=315 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=159 Participants
|
48 Participants
n=156 Participants
|
92 Participants
n=315 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Active tobacco use
|
19 Participants
n=159 Participants
|
20 Participants
n=156 Participants
|
39 Participants
n=315 Participants
|
|
COPD/asthma
|
29 Participants
n=159 Participants
|
30 Participants
n=156 Participants
|
59 Participants
n=315 Participants
|
|
allergic rhinitis
|
82 Participants
n=159 Participants
|
80 Participants
n=156 Participants
|
162 Participants
n=315 Participants
|
|
Diabetes
|
16 Participants
n=159 Participants
|
15 Participants
n=156 Participants
|
31 Participants
n=315 Participants
|
|
Heart disease
|
11 Participants
n=159 Participants
|
8 Participants
n=156 Participants
|
19 Participants
n=315 Participants
|
|
History of sinusitis
|
63 Participants
n=159 Participants
|
60 Participants
n=156 Participants
|
123 Participants
n=315 Participants
|
|
Days of illness
|
14.8 days
STANDARD_DEVIATION 8.8 • n=159 Participants
|
14.3 days
STANDARD_DEVIATION 8.1 • n=156 Participants
|
14.5 days
STANDARD_DEVIATION 8.4 • n=315 Participants
|
|
Sinusitis category 1
|
101 Participants
n=159 Participants
|
103 Participants
n=156 Participants
|
204 Participants
n=315 Participants
|
|
Sinusitis category 2
|
18 Participants
n=159 Participants
|
19 Participants
n=156 Participants
|
37 Participants
n=315 Participants
|
|
Sinusitis category 3
|
40 Participants
n=159 Participants
|
34 Participants
n=156 Participants
|
74 Participants
n=315 Participants
|
|
Day 0 SNOT-16 mean item score
|
1.89 units on a scale
STANDARD_DEVIATION .56 • n=159 Participants
|
1.99 units on a scale
STANDARD_DEVIATION .55 • n=156 Participants
|
1.94 units on a scale
STANDARD_DEVIATION .55 • n=315 Participants
|
PRIMARY outcome
Timeframe: end of 3 days of treatmentPopulation: The number of participants who gave ratings at the end of day 3 of treatment
rating of "a lot better" or "no symptoms"
Outcome measures
| Measure |
Standard Dose Time Period I
n=87 Participants
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
|
High Dose Time Period 1
n=80 Participants
extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
|
Standard Dose Time Period 2
n=64 Participants
Amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
|
High Dose Time Period 2
n=63 Participants
immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
|
|---|---|---|---|---|
|
Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")
|
33 Participants
|
31 Participants
|
22 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: day 0, end of 3 days of treatmentPopulation: The number of participants who gave ratings at 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).
Outcome measures
| Measure |
Standard Dose Time Period I
n=86 Participants
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
|
High Dose Time Period 1
n=80 Participants
extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
|
Standard Dose Time Period 2
n=62 Participants
Amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
|
High Dose Time Period 2
n=56 Participants
immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
|
|---|---|---|---|---|
|
SNOT-16 - Day 3
|
.75 units on a scale
Standard Deviation .63
|
.87 units on a scale
Standard Deviation .59
|
.91 units on a scale
Standard Deviation .63
|
.97 units on a scale
Standard Deviation .69
|
SECONDARY outcome
Timeframe: end of 10th dayPopulation: The number of participants who gave a rating at day 10.
rating of "a lot better" or "no symptoms"
Outcome measures
| Measure |
Standard Dose Time Period I
n=78 Participants
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
|
High Dose Time Period 1
n=74 Participants
extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
|
Standard Dose Time Period 2
n=50 Participants
Amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
|
High Dose Time Period 2
n=52 Participants
immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
|
|---|---|---|---|---|
|
Subjective Improvement - Day 10
|
63 Participants
|
59 Participants
|
35 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: day 0, end of 10th dayPopulation: The number of participants who gave ratings at 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).
Outcome measures
| Measure |
Standard Dose Time Period I
n=79 Participants
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
|
High Dose Time Period 1
n=75 Participants
extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
|
Standard Dose Time Period 2
n=51 Participants
Amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
|
High Dose Time Period 2
n=53 Participants
immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
|
|---|---|---|---|---|
|
SNOT-16 - Day 10
|
1.32 units on a scale
Standard Deviation .71
|
1.48 units on a scale
Standard Deviation .64
|
1.37 units on a scale
Standard Deviation .67
|
1.40 units on a scale
Standard Deviation .73
|
SECONDARY outcome
Timeframe: baselinePopulation: All 231 participants were analyzed together regardless of treatment.
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).
Outcome measures
| Measure |
Standard Dose Time Period I
n=231 Participants
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
|
High Dose Time Period 1
extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
|
Standard Dose Time Period 2
Amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
|
High Dose Time Period 2
immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
|
|---|---|---|---|---|
|
Nasal Colonization With Resistant Bacteria
No growth or normal flora
|
139 Participants
|
—
|
—
|
—
|
|
Nasal Colonization With Resistant Bacteria
Methicillin-sensitive Staphylococcus aureus
|
32 Participants
|
—
|
—
|
—
|
|
Nasal Colonization With Resistant Bacteria
Moxarella catarrhalis
|
9 Participants
|
—
|
—
|
—
|
|
Nasal Colonization With Resistant Bacteria
Staphylococcus epidermidis
|
7 Participants
|
—
|
—
|
—
|
|
Nasal Colonization With Resistant Bacteria
Methicillin-resistant Staphylococcus aureus
|
5 Participants
|
—
|
—
|
—
|
|
Nasal Colonization With Resistant Bacteria
Haemophilus influenzae
|
25 Participants
|
—
|
—
|
—
|
|
Nasal Colonization With Resistant Bacteria
Streptococcus pneumoniae
|
9 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: end of 10th daywhether participants said they would NOT take the antibiotic again
Outcome measures
| Measure |
Standard Dose Time Period I
n=75 Participants
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
|
High Dose Time Period 1
n=74 Participants
extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
|
Standard Dose Time Period 2
n=49 Participants
Amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
|
High Dose Time Period 2
n=52 Participants
immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
|
|---|---|---|---|---|
|
Willingness to Take the Study Antibiotic in the Future
|
8 Participants
|
11 Participants
|
5 Participants
|
8 Participants
|
Adverse Events
Standard Dose Time Period I
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
High Dose Time Period 1
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Standard Dose Time Period 2
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
High Dose Time Period 2
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Dose Time Period I
n=87 participants at risk；n=90 participants at risk
amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
|
High Dose Time Period 1
n=80 participants at risk；n=89 participants at risk
extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets twice a day for 7 days
|
Standard Dose Time Period 2
n=62 participants at risk；n=69 participants at risk
amoxicillin/clavulnate 875/125 plus placebo bid x 7 days
|
High Dose Time Period 2
n=57 participants at risk；n=67 participants at risk
immediate-release amoxicillin/clavunate 872/125 plus amoxicillin 875
|
|---|---|---|---|---|
|
Infections and infestations
Vaginitis
|
3.4%
3/87 • Number of events 3 • 10 days
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.
|
13.8%
11/80 • Number of events 11 • 10 days
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.
|
6.5%
4/62 • Number of events 4 • 10 days
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.
|
12.3%
7/57 • Number of events 7 • 10 days
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.
|
|
Gastrointestinal disorders
diarrhea
|
34.5%
30/87 • Number of events 30 • 10 days
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.
|
46.2%
37/80 • Number of events 37 • 10 days
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.
|
30.6%
19/62 • Number of events 19 • 10 days
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.
|
47.4%
27/57 • Number of events 27 • 10 days
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place