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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 : Completed
First Posted : July 21, 2010
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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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 Phase
Sinusitis Drug: Amoxicillin-Potassium Clavulanate Combination Drug: Placebo Not Applicable

Detailed Description:
This was a prospective, randomized, double-blind study comparing short course (5 days) to long course (14 days) antimicrobial therapy for children between 1 and 10 years of age with acute bacterial sinusitis. The major outcome measure is the proportion of children with a clinical relapse on day 10 in the short course therapy group compared to day 20 in the long course therapy group. In addition, the proportion of respiratory flora that are resistant to antibiotics on day 30 will be compared to baseline in each group.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel 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
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Short Course
Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination 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.
Other Name: there are none

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.
Other Name: there are none
Active Comparator: Long Course
Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 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.
Other Name: there are none


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) [ Time Frame: at 10 days and at 20 days ]
    Results are based on a daily 6-item symptom survey (day 1 to 14); a daily 3-item survey (day 15 to 30). If a particular symptom is present initially, a score of 2 is given; if it is absent the score is 0. A maximum entry score is 20 (persistent symptoms). If a particular symptom becomes more severe, less severe, or stays the same during treatment, +1, -1, or 0 respectively, will be added to the original score for each symptom. At 10 (and 20 days, respectively), children will be classified as cured, improved or failed based on survey results. Children will be considered cured if they reach a score of < 2. Children will be classified as improved if their score at 10 days (20 days, respectively) is at least 2 points less than their score at 5 days (15 days, respectively). Children will be considered to have failed therapy if their score worsens by + 3 between day 5 (day 15) and day 10 (day 20) or if their score at day 10 (day 20) does not meet criteria for improvement.


Secondary Outcome Measures :
  1. Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline [ Time Frame: Baseline and 30 days ]
    Percentage of participants with antibiotic resistant flora on day 30 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
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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
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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
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Principal Investigator: Ellen R Wald, MD University of Wisconsin, Madison
More Information
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Additional Information:
University of Wisconsin-Madison Department of Pediatrics Research Information  This link exits the ClinicalTrials.gov site

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01166945     History of Changes
Other Study ID Numbers: 2015-0452
130933 ( Other Identifier: Study Team )
H-2010-0129 ( Other Identifier: HS IRB )
First Posted: July 21, 2010    Key Record Dates
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019
Last Verified: June 2019
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:
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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