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Trial record 7 of 26 for:    "Sinusitis" | "Clavulanate"

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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sinusitis
Interventions Drug: Amoxicillin-Potassium Clavulanate Combination
Drug: Placebo
Enrollment 98
Recruitment Details  
Pre-assignment Details A total of 98 subjects were consented and enrolled. A total of 82 subjects completed the study through day 30. Participants were evaluated on days 5, 10, 15, and 20 for the primary outcome.
Arm/Group Title Arm A - Short Course Placebo Comparator Arm B - Long Course Treatment
Hide Arm/Group Description

Short Course Antibiotic Treatment

Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days.

Long Course Antibiotic Treatment

Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days.

Period Title: Randomized
Started 51 47
Completed 47 43
Not Completed 4 4
Reason Not Completed
diagnosed with Group A strep             4             4
Period Title: Day 5
Started 47 43
Completed 47 43
Not Completed 0 0
Period Title: Day 10
Started 47 43
Completed 44 41
Not Completed 3 2
Reason Not Completed
NonCompliance/Lost to Follow Up             3             2
Period Title: Day 15
Started 44 41
Completed 42 40
Not Completed 2 1
Reason Not Completed
NonCompliance/Lost to Follow Up             2             1
Period Title: Day 20
Started 42 40
Completed 42 40
Not Completed 0 0
Period Title: Day 30
Started 42 40
Completed 38 37
Not Completed 4 3
Reason Not Completed
Lost to Follow-up             4             3
Arm/Group Title Arm A Arm B Total
Hide Arm/Group Description Short Course Antibiotic Long Course Antibiotic Total of all reporting groups
Overall Number of Baseline Participants 51 47 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 47 participants 98 participants
5.7  (2.8) 5.0  (2.9) 5.4  (2.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 47 participants 98 participants
Female
23
  45.1%
24
  51.1%
47
  48.0%
Male
28
  54.9%
23
  48.9%
51
  52.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 47 participants 98 participants
American Indian or Alaska Native
0
   0.0%
1
   2.1%
1
   1.0%
Asian
1
   2.0%
2
   4.3%
3
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   3.9%
5
  10.6%
7
   7.1%
White
48
  94.1%
39
  83.0%
87
  88.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 51 participants 47 participants 98 participants
22.7  (10.3) 22.6  (12.2) 22.65  (11.25)
Temperature at enrollment  
Mean (Standard Deviation)
Unit of measure:  Celsius
Number Analyzed 51 participants 47 participants 98 participants
110.2  (32.8) 102.5  (20.6) 106.4  (26.7)
1.Primary Outcome
Title Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course)
Hide Description 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.
Time Frame at 10 days and at 20 days
Hide Outcome Measure Data
Hide Analysis Population Description
98 participants were enrolled, and 82 completed through day 20. Participant numbers change from day 10 to day 20 due to Group A Strep diagnosis, non-compliance, and lost to follow up over the course of the study.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
Short Course Antibiotic
Long Course Antibiotic
Overall Number of Participants Analyzed 51 47
Measure Type: Count of Participants
Unit of Measure: Participants
Day 10 Number Analyzed 44 participants 41 participants
Failed
13
  29.5%
8
  19.5%
Improved
9
  20.5%
10
  24.4%
Cured
22
  50.0%
23
  56.1%
Day 20 Number Analyzed 42 participants 40 participants
Failed
16
  38.1%
13
  32.5%
Improved
4
   9.5%
3
   7.5%
Cured
22
  52.4%
24
  60.0%
2.Secondary Outcome
Title Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline
Hide Description Percentage of participants with antibiotic resistant flora on day 30 compared to baseline
Time Frame Baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants at baseline differed from the number of participants at Day 30 as they were lost to follow up
Arm/Group Title Short Course Long Course
Hide Arm/Group Description:

Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days.

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.

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.

Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days.

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.

Overall Number of Participants Analyzed 50 46
Measure Type: Count of Participants
Unit of Measure: Participants
Haemophilis Influenza - Baseline Number Analyzed 49 participants 46 participants
13
  26.5%
13
  28.3%
Haemophilis Influenza - Day 30 Number Analyzed 38 participants 37 participants
7
  18.4%
5
  13.5%
Moraxella Catarrhalis - Baseline Number Analyzed 49 participants 46 participants
10
  20.4%
13
  28.3%
Moraxella Catarrhalis - Day 30 Number Analyzed 38 participants 37 participants
11
  28.9%
7
  18.9%
Streptococccus Pneumonia - Baseline Number Analyzed 49 participants 46 participants
11
  22.4%
8
  17.4%
Streptococccus Pneumonia - Day 30 Number Analyzed 38 participants 37 participants
8
  21.1%
3
   8.1%
Streptococcus - Baseline Number Analyzed 49 participants 46 participants
6
  12.2%
2
   4.3%
Streptococcus - Day 30 Number Analyzed 38 participants 37 participants
0
   0.0%
0
   0.0%
Staphylococcus Aureus - Baseline Number Analyzed 50 participants 46 participants
2
   4.0%
2
   4.3%
Staphylococcus Aureus - Day 30 Number Analyzed 38 participants 37 participants
0
   0.0%
1
   2.7%
No Growth - Baseline Number Analyzed 49 participants 46 participants
0
   0.0%
3
   6.5%
No Growth - Day 30 Number Analyzed 38 participants 37 participants
6
  15.8%
3
   8.1%
Other - Baseline Number Analyzed 49 participants 46 participants
42
  85.7%
36
  78.3%
Other - Day 30 Number Analyzed 38 participants 37 participants
29
  76.3%
32
  86.5%
Time Frame Days 1 through 30
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A Arm B
Hide Arm/Group Description Short Course Antibiotic Treatment Long Course Antibiotic Treatment
All-Cause Mortality
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)      0/47 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/51 (0.00%)      0/47 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/51 (86.27%)      47/47 (100.00%)    
Gastrointestinal disorders     
Abdominal Pain  [1]  13/51 (25.49%)  23 21/47 (44.68%)  30
Diarrhea  [1]  18/51 (35.29%)  24 14/47 (29.79%)  24
Vomiting  [1]  7/51 (13.73%)  7 13/47 (27.66%)  17
Skin and subcutaneous tissue disorders     
Rash  [1]  6/51 (11.76%)  7 8/47 (17.02%)  15
Indicates events were collected by systematic assessment
[1]
Data for number of participants affected is unavailable.
Total number of participants experiencing adverse events is unavailable, the maximum number of participants is reported. The possible range for Arm A is 18-44, the possible range for Arm B is 21-47.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ellen Wald, MD
Organization: University of Wisconsin School of Medicine and Public Health
Phone: 608-263-8558
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 Submitted: July 15, 2010
First Posted: July 21, 2010
Results First Submitted: October 19, 2018
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019