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

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ClinicalTrials.gov Identifier: NCT01166945
Recruitment Status : Active, not recruiting
First Posted : July 21, 2010
Last Update Posted : September 12, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Sinusitis Drug: Amoxicillin-Potassium Clavulanate Combination Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
Study Start Date : November 2010
Primary Completion Date : April 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Amoxicillin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Comparison of short course to long course antimicrobials. [ Time Frame: 2 years ]
    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.


Eligibility Criteria

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166945


Locations
United States, Wisconsin
UW Health Pediatrics (Park St)
Madison, Wisconsin, United States, 53715
UW Health Pediatrics (WestTowne)
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:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01166945     History of Changes
Other Study ID Numbers: 130933
First Posted: July 21, 2010    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Anti-Bacterial Agents
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action