Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children - Full Text View

Purpose

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.

Condition	Intervention
Sinusitis	Drug: Amoxicillin-Potassium Clavulanate Combination Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children

Resource links provided by NLM:

MedlinePlus related topics: Potassium Sinusitis

Drug Information available for: Potassium bicarbonate Potassium chloride Amoxicillin Amoxicillin sodium Clavulanate potassium

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Comparison of short course to long course antimicrobials. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The Aim of this project is to compare short course (5 days) to long course (14 days) antimicrobials for the treatment of acute bacterial sinusitis in children between 1 and 10 years of age. The effectiveness of the treatments will be compared with regard to (a) the likelihood of failure (clinical relapse) at 10 and 20 days in the short and long term treatment groups, respectively and (b) the development of antimicrobial resistance among the normal nasopharyngeal flora 30 days after treatment has been initiated compared to baseline.

Estimated Enrollment:	240
Study Start Date:	November 2010
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Short Course Short course (5 days) of antimicrobial therapy and placebo for next 9 days.	Drug: Amoxicillin-Potassium Clavulanate Combination All 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: Placebo 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.
Active Comparator: Long Course Long course (14 days) of antimicrobial therapy.	Drug: Amoxicillin-Potassium Clavulanate Combination All 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.

Arms

Assigned Interventions

Placebo Comparator: Short Course

Short course (5 days) of antimicrobial therapy and placebo for next 9 days.

Drug: Amoxicillin-Potassium Clavulanate Combination

All 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: Placebo

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.

Active Comparator: Long Course

Long course (14 days) of antimicrobial therapy.

Drug: Amoxicillin-Potassium Clavulanate Combination

All 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.

Eligibility

Ages Eligible for Study:	1 Year to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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:

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; and
been diagnosed with either immunodeficiency or anatomic abnormality of the upper respiratory tract.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166945

Contacts

Contact: Stacey Moyer, MSN

608-262-9531

scmoyer@pediatrics.wisc.edu

Locations

United States, Wisconsin
UW Health Pediatrics (Park St)	Recruiting
Madison, Wisconsin, United States, 53715
UW Health Pediatrics (WestTowne)	Recruiting
Madison, Wisconsin, United States, 53717

Sponsors and Collaborators

University of Wisconsin, Madison

Thrasher Research Fund

Investigators

Principal Investigator:

Ellen R Wald, MD

University of Wisconsin, Madison

More Information

Additional Information:

University of Wisconsin-Madison Department of Pediatrics Research Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT01166945 History of Changes
Other Study ID Numbers:	130933
Study First Received:	July 15, 2010
Last Updated:	December 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:

Child
Child, preschool
Sinusitis
Antimicrobial agents

Additional relevant MeSH terms:

Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination

Clavulanic Acids
Clavulanic Acid
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013