N/A
N=98
Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT01166945 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) — 13; 8; 9; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Amoxicillin-Potassium Clavulanate Combination (Drug); Placebo (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) |
13; 8; 9; 10; 22; 23 | — |
| SECONDARY Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline |
13; 13; 7; 5; 10; 13 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01166945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.