Back to resultsShort (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
Primary Purpose
Sinusitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amoxicillin-Potassium Clavulanate Combination
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sinusitis focused on measuring Child, Child, preschool, Sinusitis, Antimicrobial agents
Eligibility Criteria
Inclusion Criteria:
- children with nasal discharge (of any quality) or daytime cough (which may be worse at night) or both persisting for 10 days or more without evidence of improvement.
- families need to be English speaking
Exclusion Criteria:
- used antibiotics within the last 15 days;
- had symptoms for > 30 days;
- have concurrent streptococcal pharyngitis or acute otitis media (as the standard doses for both of these conditions is 10 days);
- are allergic to penicillin;
- have symptoms that suggest a complication due to acute bacterial sinusitis that necessitates hospitalization, intravenous antibiotics or sub-specialty evaluation
- been diagnosed with either immunodeficiency or anatomic abnormality of the upper respiratory tract
- history of recurrent acute sinusitis (more than 3 episodes in 6 months or 4 episodes in a year)
- history of chronic sinusitis (more than 90 days of respiratory symptoms in this or the previous respiratory season)
- girls who have begun menstruating
Sites / Locations
- UW Health Pediatrics (Park St)
- UW Health Pediatrics (WestTowne)
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Short Course
Long Course
Arm Description
Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days.
Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days.
Outcomes
Primary Outcome Measures
Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course)
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.
Secondary Outcome Measures
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline
Percentage of participants with antibiotic resistant flora on day 30 compared to baseline
Full Information
NCT ID
NCT01166945
First Posted
July 15, 2010
Last Updated
June 7, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
Thrasher Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT01166945
Brief Title
Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
Official Title
Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Thrasher Research Fund
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators objective is to compare short course (5 days) to long course (14 days)antibiotics for the treatment of acute bacterial sinusitis in children. The investigators hypothesize that short course therapy will lead to more frequent relapses of sinusitis and will not reduce resistant organisms.
Detailed Description
This was a prospective, randomized, double-blind study comparing short course (5 days) to long course (14 days) antimicrobial therapy for children between 1 and 10 years of age with acute bacterial sinusitis. The major outcome measure is the proportion of children with a clinical relapse on day 10 in the short course therapy group compared to day 20 in the long course therapy group. In addition, the proportion of respiratory flora that are resistant to antibiotics on day 30 will be compared to baseline in each group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
Child, Child, preschool, Sinusitis, Antimicrobial agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short Course
Arm Type
Placebo Comparator
Arm Description
Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days.
Arm Title
Long Course
Arm Type
Active Comparator
Arm Description
Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin-Potassium Clavulanate Combination
Other Intervention Name(s)
there are none
Intervention Description
All subjects will be started on treatment with 5 days of high dose amoxicillin (90mg/kg) with potassium clavulanate (6.4 mg/kg) twice daily in bottle A. The allocation to group B1 or B2 will be concealed until after the family and subject has signed the assent and consent, respectively. The maximum dose will be 2 gms twice daily. After 5 days the subjects will be randomized to either continue to receive the same dose of amoxicillin clavulanate or a look-a-like and taste-a-like placebo for the next 9 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
there are none
Intervention Description
After 5 days the subjects will be randomized to either continue to receive the same dose of amoxicillin clavulanate or a look-a-like and taste-a-like placebo for the next 9 days.
Primary Outcome Measure Information:
Title
Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course)
Description
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.
Time Frame
at 10 days and at 20 days
Secondary Outcome Measure Information:
Title
Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline
Description
Percentage of participants with antibiotic resistant flora on day 30 compared to baseline
Time Frame
Baseline and 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children with nasal discharge (of any quality) or daytime cough (which may be worse at night) or both persisting for 10 days or more without evidence of improvement.
families need to be English speaking
Exclusion Criteria:
used antibiotics within the last 15 days;
had symptoms for > 30 days;
have concurrent streptococcal pharyngitis or acute otitis media (as the standard doses for both of these conditions is 10 days);
are allergic to penicillin;
have symptoms that suggest a complication due to acute bacterial sinusitis that necessitates hospitalization, intravenous antibiotics or sub-specialty evaluation
been diagnosed with either immunodeficiency or anatomic abnormality of the upper respiratory tract
history of recurrent acute sinusitis (more than 3 episodes in 6 months or 4 episodes in a year)
history of chronic sinusitis (more than 90 days of respiratory symptoms in this or the previous respiratory season)
girls who have begun menstruating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen R Wald, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW Health Pediatrics (Park St)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
UW Health Pediatrics (WestTowne)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.pediatrics.wisc.edu/research/
Description
University of Wisconsin-Madison Department of Pediatrics Research Information
Learn more about this trial
Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
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