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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

Tracking Information
First Submitted Date  ICMJE July 15, 2010
First Posted Date  ICMJE July 21, 2010
Results First Submitted Date  ICMJE October 19, 2018
Results First Posted Date  ICMJE June 10, 2019
Last Update Posted Date June 10, 2019
Study Start Date  ICMJE November 2010
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2010)
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.
Change History Complete list of historical versions of study NCT01166945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
Official Title  ICMJE Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sinusitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Short Course
    Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days.
    Interventions:
    • Drug: Amoxicillin-Potassium Clavulanate Combination
    • Drug: Placebo
  • Active Comparator: Long Course
    Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days.
    Intervention: Drug: Amoxicillin-Potassium Clavulanate Combination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2016)
98
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2010)
240
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01166945
Other Study ID Numbers  ICMJE 2015-0452
130933 ( Other Identifier: Study Team )
H-2010-0129 ( Other Identifier: HS IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Thrasher Research Fund
Investigators  ICMJE
Principal Investigator: Ellen R Wald, MD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP