Sinusitis Clinical Trial
Official title:
Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
Verified date | June 2019 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 10 Years |
Eligibility |
Inclusion Criteria: 1. 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. 2. families need to be English speaking Exclusion Criteria: 1. used antibiotics within the last 15 days; 2. had symptoms for > 30 days; 3. have concurrent streptococcal pharyngitis or acute otitis media (as the standard doses for both of these conditions is 10 days); 4. are allergic to penicillin; 5. have symptoms that suggest a complication due to acute bacterial sinusitis that necessitates hospitalization, intravenous antibiotics or sub-specialty evaluation 6. been diagnosed with either immunodeficiency or anatomic abnormality of the upper respiratory tract 7. history of recurrent acute sinusitis (more than 3 episodes in 6 months or 4 episodes in a year) 8. history of chronic sinusitis (more than 90 days of respiratory symptoms in this or the previous respiratory season) 9. girls who have begun menstruating |
Country | Name | City | State |
---|---|---|---|
United States | UW Health Pediatrics (Park St) | Madison | Wisconsin |
United States | UW Health Pediatrics (WestTowne) | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | Thrasher Research Fund |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | at 10 days and at 20 days | |
Secondary | 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 | Baseline and 30 days |
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