Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
Information source: University of Wisconsin, Madison
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sinusitis
Intervention: Amoxicillin-Potassium Clavulanate Combination (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Wisconsin, Madison Official(s) and/or principal investigator(s):
Ellen R Wald, MD, Principal Investigator, Affiliation: University of Wisconsin, Madison
Overall contact:
Stacey Moyer, MSN, Phone: 608-262-9531, Email: scmoyer@pediatrics.wisc.edu
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.
Clinical Details
Official title: Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Comparison of short course to long course antimicrobials.
Eligibility
Minimum age: 1 Year.
Maximum age: 10 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. children with nasal discharge (of any quality) or daytime cough (which may be worse
at night) or both persisting for more than 10 days without evidence of improvement.
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;
and
6. been diagnosed with either immunodeficiency or anatomic abnormality of the upper
respiratory tract.
Locations and Contacts
Stacey Moyer, MSN, Phone: 608-262-9531, Email: scmoyer@pediatrics.wisc.edu
UW Health Pediatrics (Park St), Madison, Wisconsin 53715, United States; Recruiting
UW Health Pediatrics (WestTowne), Madison, Wisconsin 53717, United States; Recruiting
Additional Information
University of Wisconsin-Madison Department of Pediatrics Research Information
Starting date: November 2010
Last updated: December 13, 2011
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