Sinusitis | Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
Sinusitis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Amoxicillin-Potassium Clavulanate CombinationAll 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.
Drug:PlaceboAfter 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Short CourseShort course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days.
Long CourseLong course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days.
Start Date: November 2010
Completed Date: February 2016
Primary Outcome: Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course)
Secondary Outcome: Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline
Study sponsors, principal investigator, and references
Principal Investigator: Ellen R Wald, MD
Lead Sponsor: University of Wisconsin, Madison
Collaborator: Thrasher Research Fund