Clinical trial NCT01166945: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Keywords: Child
Child, preschool
Sinusitis
Antimicrobial agents
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2010-07-21
Enrollment: 98
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course)
timeFrame: at 10 days and at 20 days
Secondary outcomes:
measure: Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline
timeFrame: Baseline and 30 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Health Pediatrics (Park St)
state: Wisconsin
city: Madison
country: United States
facility: UW Health Pediatrics (WestTowne)
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ellen R Wald, MD
role: PRINCIPAL_INVESTIGATOR
References: