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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

Page last updated: February 07, 2013

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