Trial Outcomes & Findings for Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children (NCT NCT01166945)

Last Updated: 2019-06-10

Results Overview

Results are based on a daily 6-item symptom survey (day 1 to 14); a daily 3-item survey (day 15 to 30). If a particular symptom is present initially, a score of 2 is given; if it is absent the score is 0. A maximum entry score is 20 (persistent symptoms). If a particular symptom becomes more severe, less severe, or stays the same during treatment, +1, -1, or 0 respectively, will be added to the original score for each symptom. At 10 (and 20 days, respectively), children will be classified as cured, improved or failed based on survey results. Children will be considered cured if they reach a score of \< 2. Children will be classified as improved if their score at 10 days (20 days, respectively) is at least 2 points less than their score at 5 days (15 days, respectively). Children will be considered to have failed therapy if their score worsens by + 3 between day 5 (day 15) and day 10 (day 20) or if their score at day 10 (day 20) does not meet criteria for improvement.

Recruitment status

COMPLETED

Study phase

Target enrollment

98 participants

Primary outcome timeframe

at 10 days and at 20 days

Results posted on

2019-06-10

Participant Flow

A total of 98 subjects were consented and enrolled. A total of 82 subjects completed the study through day 30. Participants were evaluated on days 5, 10, 15, and 20 for the primary outcome.

Participant milestones

Participant milestones
Measure	Arm A - Short Course Placebo Comparator Short Course Antibiotic Treatment Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days.	Arm B - Long Course Treatment Long Course Antibiotic Treatment Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days.
Randomized STARTED	51	47
Randomized COMPLETED	47	43
Randomized NOT COMPLETED	4	4
Day 5 STARTED	47	43
Day 5 COMPLETED	47	43
Day 5 NOT COMPLETED	0	0
Day 10 STARTED	47	43
Day 10 COMPLETED	44	41
Day 10 NOT COMPLETED	3	2
Day 15 STARTED	44	41
Day 15 COMPLETED	42	40
Day 15 NOT COMPLETED	2	1
Day 20 STARTED	42	40
Day 20 COMPLETED	42	40
Day 20 NOT COMPLETED	0	0
Day 30 STARTED	42	40
Day 30 COMPLETED	38	37
Day 30 NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A - Short Course Placebo Comparator Short Course Antibiotic Treatment Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days.	Arm B - Long Course Treatment Long Course Antibiotic Treatment Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days.
Randomized diagnosed with Group A strep	4	4
Day 10 NonCompliance/Lost to Follow Up	3	2
Day 15 NonCompliance/Lost to Follow Up	2	1
Day 30 Lost to Follow-up	4	3

Baseline Characteristics

Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=51 Participants Short Course Antibiotic	Arm B n=47 Participants Long Course Antibiotic	Total n=98 Participants Total of all reporting groups
Age, Continuous	5.7 years STANDARD_DEVIATION 2.8 • n=5 Participants	5.0 years STANDARD_DEVIATION 2.9 • n=7 Participants	5.4 years STANDARD_DEVIATION 2.85 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	23 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	39 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Weight	22.7 kg STANDARD_DEVIATION 10.3 • n=5 Participants	22.6 kg STANDARD_DEVIATION 12.2 • n=7 Participants	22.65 kg STANDARD_DEVIATION 11.25 • n=5 Participants
Temperature at enrollment	110.2 celsius STANDARD_DEVIATION 32.8 • n=5 Participants	102.5 celsius STANDARD_DEVIATION 20.6 • n=7 Participants	106.4 celsius STANDARD_DEVIATION 26.7 • n=5 Participants

PRIMARY outcome

Timeframe: at 10 days and at 20 days

Population: 98 participants were enrolled, and 82 completed through day 20. Participant numbers change from day 10 to day 20 due to Group A Strep diagnosis, non-compliance, and lost to follow up over the course of the study.

Outcome measures

Outcome measures
Measure	Arm A n=51 Participants Short Course Antibiotic	Arm B n=47 Participants Long Course Antibiotic
Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) Day 10 · Failed	13 Participants	8 Participants
Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) Day 10 · Improved	9 Participants	10 Participants
Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) Day 10 · Cured	22 Participants	23 Participants
Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) Day 20 · Failed	16 Participants	13 Participants
Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) Day 20 · Improved	4 Participants	3 Participants
Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) Day 20 · Cured	22 Participants	24 Participants

SECONDARY outcome

Timeframe: Baseline and 30 days

Population: Number of participants at baseline differed from the number of participants at Day 30 as they were lost to follow up

Percentage of participants with antibiotic resistant flora on day 30 compared to baseline

Outcome measures

Outcome measures
Measure	Arm A n=50 Participants Short Course Antibiotic	Arm B n=46 Participants Long Course Antibiotic
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline Haemophilis Influenza - Baseline	13 Participants	13 Participants
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline Haemophilis Influenza - Day 30	7 Participants	5 Participants
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline Moraxella Catarrhalis - Baseline	10 Participants	13 Participants
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline Moraxella Catarrhalis - Day 30	11 Participants	7 Participants
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline Streptococccus Pneumonia - Baseline	11 Participants	8 Participants
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline Streptococccus Pneumonia - Day 30	8 Participants	3 Participants
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline Streptococcus - Baseline	6 Participants	2 Participants
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline Streptococcus - Day 30	0 Participants	0 Participants
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline Staphylococcus Aureus - Baseline	2 Participants	2 Participants
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline Staphylococcus Aureus - Day 30	0 Participants	1 Participants
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline No Growth - Baseline	0 Participants	3 Participants
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline No Growth - Day 30	6 Participants	3 Participants
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline Other - Baseline	42 Participants	36 Participants
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline Other - Day 30	29 Participants	32 Participants

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm A n=51 participants at risk Short Course Antibiotic Treatment	Arm B n=47 participants at risk Long Course Antibiotic Treatment
Gastrointestinal disorders Abdominal Pain	25.5% 13/51 • Number of events 23 • Days 1 through 30	44.7% 21/47 • Number of events 30 • Days 1 through 30
Gastrointestinal disorders Diarrhea	35.3% 18/51 • Number of events 24 • Days 1 through 30	29.8% 14/47 • Number of events 24 • Days 1 through 30
Skin and subcutaneous tissue disorders Rash	11.8% 6/51 • Number of events 7 • Days 1 through 30	17.0% 8/47 • Number of events 15 • Days 1 through 30
Gastrointestinal disorders Vomiting	13.7% 7/51 • Number of events 7 • Days 1 through 30	27.7% 13/47 • Number of events 17 • Days 1 through 30

Additional Information

Ellen Wald, MD

University of Wisconsin School of Medicine and Public Health

Phone: 608-263-8558

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place