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| ID | Type | Description | Link |
|---|---|---|---|
| 130933 | Other Identifier | Study Team | |
| H-2010-0129 | Other Identifier | HS IRB |
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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short Course | Placebo Comparator | Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days. |
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| Long Course | Active Comparator | Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin-Potassium Clavulanate Combination | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | 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. | at 10 days and at 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Percentage of participants with antibiotic resistant flora on day 30 compared to baseline | Baseline and 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen R Wald, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Health Pediatrics (Park St) | Madison | Wisconsin | 53715 | United States | ||
| UW Health Pediatrics (WestTowne) |
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| Label | URL |
|---|---|
| University of Wisconsin-Madison Department of Pediatrics Research Information | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A - Short Course Placebo Comparator | Short Course Antibiotic Treatment Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days. |
| FG001 | Arm B - Long Course Treatment | Long Course Antibiotic Treatment Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized |
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| Day 5 |
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| Day 10 |
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| Day 15 |
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| Day 20 |
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| Day 30 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Short Course Antibiotic |
| BG001 | Arm B | Long Course Antibiotic |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | 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. | 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. | Posted | Count of Participants | Participants | at 10 days and at 20 days |
Days 1 through 30
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | Short Course Antibiotic Treatment | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Wald, MD | University of Wisconsin School of Medicine and Public Health | 608-263-8558 | erwald@pediatrics.wisc.edu |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
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| Placebo | Drug | 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. |
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| Madison |
| Wisconsin |
| 53717 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Total |
Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kg |
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| Temperature at enrollment | Mean | Standard Deviation | celsius |
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| Secondary | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Percentage of participants with antibiotic resistant flora on day 30 compared to baseline | Number of participants at baseline differed from the number of participants at Day 30 as they were lost to follow up | Posted | Count of Participants | Participants | Baseline and 30 days |
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| 51 |
| 0 |
| 51 |
| 44 |
| 51 |
| EG001 | Arm B | Long Course Antibiotic Treatment | 0 | 47 | 0 | 47 | 47 | 47 |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Data for number of participants affected is unavailable. |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Data for number of participants affected is unavailable. |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment | Data for number of participants affected is unavailable. |
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| Improved |
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| Cured |
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| Haemophilis Influenza - Day 30 |
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| Moraxella Catarrhalis - Baseline |
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| Moraxella Catarrhalis - Day 30 |
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| Streptococccus Pneumonia - Baseline |
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| Streptococccus Pneumonia - Day 30 |
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| Streptococcus - Baseline |
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| Streptococcus - Day 30 |
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| Staphylococcus Aureus - Baseline |
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| Staphylococcus Aureus - Day 30 |
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| No Growth - Baseline |
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| No Growth - Day 30 |
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| Other - Baseline |
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| Other - Day 30 |
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