Sinusitis
Conditions
Keywords
Child, Child, preschool, Sinusitis, Antimicrobial agents
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.
Interventions
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.
DRUGPlacebo
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.
Sponsors
Thrasher Research Fund
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Baseline and 30 days | Percentage of participants with antibiotic resistant flora on day 30 compared to baseline |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Arm A Short Course Antibiotic | 51 |
| Arm B Long Course Antibiotic | 47 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Day 10 | NonCompliance/Lost to Follow Up | 3 | 2 |
| Day 15 | NonCompliance/Lost to Follow Up | 2 | 1 |
| Day 30 | Lost to Follow-up | 4 | 3 |
| Randomized | diagnosed with Group A strep | 4 | 4 |
Baseline characteristics
| Characteristic | Arm A | Arm B | Total |
|---|---|---|---|
| Age, Continuous | 5.7 years STANDARD_DEVIATION 2.8 | 5.0 years STANDARD_DEVIATION 2.9 | 5.4 years STANDARD_DEVIATION 2.85 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 39 Participants | 87 Participants |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Male | 28 Participants | 23 Participants | 51 Participants |
| Temperature at enrollment | 110.2 celsius STANDARD_DEVIATION 32.8 | 102.5 celsius STANDARD_DEVIATION 20.6 | 106.4 celsius STANDARD_DEVIATION 26.7 |
| Weight | 22.7 kg STANDARD_DEVIATION 10.3 | 22.6 kg STANDARD_DEVIATION 12.2 | 22.65 kg STANDARD_DEVIATION 11.25 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 47 |
| other Total, other adverse events | 44 / 51 | 47 / 47 |
| serious Total, serious adverse events | 0 / 51 | 0 / 47 |
Outcome results
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.
Time frame: at 10 days and at 20 days
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Arm A | Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | Day 10 | Failed | 13 Participants |
| Arm A | Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | Day 10 | Improved | 9 Participants |
| Arm A | Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | Day 10 | Cured | 22 Participants |
| Arm A | Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | Day 20 | Failed | 16 Participants |
| Arm A | Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | Day 20 | Improved | 4 Participants |
| Arm A | Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | Day 20 | Cured | 22 Participants |
| Arm B | Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | Day 20 | Improved | 3 Participants |
| Arm B | Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | Day 10 | Failed | 8 Participants |
| Arm B | Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | Day 20 | Failed | 13 Participants |
| Arm B | Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | Day 10 | Improved | 10 Participants |
| Arm B | Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | Day 20 | Cured | 24 Participants |
| Arm B | Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course) | Day 10 | Cured | 23 Participants |
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
Time frame: Baseline and 30 days
Population: Number of participants at baseline differed from the number of participants at Day 30 as they were lost to follow up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Moraxella Catarrhalis - Day 30 | 11 Participants |
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Streptococcus - Day 30 | 0 Participants |
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Haemophilis Influenza - Baseline | 13 Participants |
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Staphylococcus Aureus - Baseline | 2 Participants |
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Streptococccus Pneumonia - Baseline | 11 Participants |
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Staphylococcus Aureus - Day 30 | 0 Participants |
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Moraxella Catarrhalis - Baseline | 10 Participants |
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | No Growth - Baseline | 0 Participants |
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Streptococccus Pneumonia - Day 30 | 8 Participants |
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | No Growth - Day 30 | 6 Participants |
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Other - Baseline | 42 Participants |
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Haemophilis Influenza - Day 30 | 7 Participants |
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Other - Day 30 | 29 Participants |
| Arm A | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Streptococcus - Baseline | 6 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Other - Day 30 | 32 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Haemophilis Influenza - Baseline | 13 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Haemophilis Influenza - Day 30 | 5 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Moraxella Catarrhalis - Baseline | 13 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Moraxella Catarrhalis - Day 30 | 7 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Streptococccus Pneumonia - Baseline | 8 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Streptococccus Pneumonia - Day 30 | 3 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Streptococcus - Baseline | 2 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Streptococcus - Day 30 | 0 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Staphylococcus Aureus - Baseline | 2 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Staphylococcus Aureus - Day 30 | 1 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | No Growth - Baseline | 3 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | Other - Baseline | 36 Participants |
| Arm B | Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline | No Growth - Day 30 | 3 Participants |