Trial Outcomes & Findings for Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial (NCT NCT01919411)

NCT ID: NCT01919411

Last Updated: 2020-02-25

Results Overview

The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis. Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 134 participants
• Primary outcome timeframe: One week post operatively
• Results posted on: 2020-02-25

Participant Flow

134 participants signed consent, but only 89 were randomized. The remainder failed screening.

Participant milestones

Measure	Amoxicillin-Potassium Clavulanate All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.	Placebo All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
Overall Study STARTED	43	46
Overall Study COMPLETED	38	41
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Measure	Amoxicillin-Potassium Clavulanate All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.	Placebo All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
Overall Study Lost to Follow-up	2	4
Overall Study Physician Decision	1	0
Overall Study Protocol Violation	2	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Amoxicillin-Potassium Clavulanate n=38 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.	Placebo n=41 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.	Total n=79 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=38 Participants	0 Participants n=41 Participants	0 Participants n=79 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=38 Participants	40 Participants n=41 Participants	77 Participants n=79 Participants
Age, Categorical >=65 years	1 Participants n=38 Participants	1 Participants n=41 Participants	2 Participants n=79 Participants
Age, Continuous	46.5 years n=38 Participants	40.8 years n=41 Participants	43.65 years n=79 Participants
Sex: Female, Male Female	14 Participants n=38 Participants	13 Participants n=41 Participants	27 Participants n=79 Participants
Sex: Female, Male Male	24 Participants n=38 Participants	28 Participants n=41 Participants	52 Participants n=79 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	38 participants n=38 Participants	41 participants n=41 Participants	79 participants n=79 Participants
Lund Kennedy Endoscopic Score	8.2 units on a scale n=38 Participants	8.2 units on a scale n=41 Participants	8.2 units on a scale n=79 Participants
SNOT-22 Scores	47.8 units on a scale n=38 Participants	39.0 units on a scale n=41 Participants	43.4 units on a scale n=79 Participants

PRIMARY outcome

Timeframe: One week post operatively

The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis.

Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms.

Outcome measures

Measure	Amoxicillin-Potassium Clavulanate n=38 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.	Placebo n=41 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
Sinonasal Outcome Test - 22	31.3 score on a scale Standard Deviation 21.7	31.0 score on a scale Standard Deviation 19.4

PRIMARY outcome

Timeframe: Six weeks post operatively

The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis.

Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms.

Outcome measures

Measure	Amoxicillin-Potassium Clavulanate n=38 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.	Placebo n=41 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
Sinonasal Outcome Test - 22	22.3 score on a scale Standard Deviation 21.5	17.5 score on a scale Standard Deviation 15.3

SECONDARY outcome

Timeframe: One week postoperatively

The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting).

Scores range from 0 to 20 with higher scores indicating greater sinus disease.

Outcome measures

Measure	Amoxicillin-Potassium Clavulanate n=38 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.	Placebo n=41 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
Lund Kennedy Endoscopic Score	5.6 score on a scale Standard Deviation 1.8	5.9 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Six weeks postoperatively

The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting).

Scores range from 0 to 20 with higher scores indicating greater sinus disease.

Outcome measures

Measure	Amoxicillin-Potassium Clavulanate n=38 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.	Placebo n=41 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
Lund Kennedy Endoscopic Score	4.3 score on a scale Standard Deviation 2.6	4.5 score on a scale Standard Deviation 2.8

OTHER_PRE_SPECIFIED outcome

Timeframe: One week postoperatively

The investigators will record the rate of post operative infections in the two groups.

Outcome measures

Measure	Amoxicillin-Potassium Clavulanate n=38 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.	Placebo n=41 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
Number of Participants With Post Operative Infection	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Six weeks postoperatively

The investigators will record the rate of post operative infections in the two groups.

Outcome measures

Measure	Amoxicillin-Potassium Clavulanate n=38 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.	Placebo n=41 Participants All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
Number of Participants With Post Operative Infection	0 Participants	0 Participants

Adverse Events

Amoxicillin-Potassium Clavulanate

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Amoxicillin-Potassium Clavulanate n=43 participants at risk All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of augmentin (amoxicillin-clavulanate) 500mg orally twice a day after surgery.	Placebo n=46 participants at risk All patients in the study will undergo endoscopic sinus surgery. This arm will receive 7 days of placebo orally twice a day after surgery.
Gastrointestinal disorders Diarrhea	20.9% 9/43 • Number of events 9 • Follow-ups at one week post-surgery and then 6 weeks post-surgery	2.2% 1/46 • Number of events 1 • Follow-ups at one week post-surgery and then 6 weeks post-surgery
Infections and infestations Infection	2.3% 1/43 • Number of events 1 • Follow-ups at one week post-surgery and then 6 weeks post-surgery	0.00% 0/46 • Follow-ups at one week post-surgery and then 6 weeks post-surgery

Additional Information

Dr. Eric Holbrook

Massachusetts Eye & Ear Infirmary

Phone: 617-573-3209

Email: Eric_Holbrook@meei.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place