Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
This trial is active, not recruiting.
|Treatments||amoxicillin-potassium clavulanate combination, placebo|
|Sponsor||University of Wisconsin, Madison|
|Collaborator||Thrasher Research Fund|
|Start date||November 2010|
|End date||April 2016|
|Trial size||98 participants|
|Trial identifier||NCT01166945, 130933|
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.
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver, outcomes assessor)|
Comparison of short course to long course antimicrobials.
time frame: 2 years
Male or female participants from 1 year up to 10 years old.
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
|Official title||Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children|
|Principal investigator||Ellen R Wald, MD|
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