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
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Condition or disease | Intervention/treatment | Phase |
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Sinusitis | Drug: Amoxicillin-Potassium Clavulanate Combination Drug: Placebo | Not Applicable |
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 |

Arm | Intervention/treatment |
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Placebo Comparator: Short Course
Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days.
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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.
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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 |
- 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.
- 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

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Ages Eligible for Study: | 1 Year to 10 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- families need to be English speaking
Exclusion Criteria:
- used antibiotics within the last 15 days;
- had symptoms for > 30 days;
- have concurrent streptococcal pharyngitis or acute otitis media (as the standard doses for both of these conditions is 10 days);
- are allergic to penicillin;
- have symptoms that suggest a complication due to acute bacterial sinusitis that necessitates hospitalization, intravenous antibiotics or sub-specialty evaluation
- been diagnosed with either immunodeficiency or anatomic abnormality of the upper respiratory tract
- history of recurrent acute sinusitis (more than 3 episodes in 6 months or 4 episodes in a year)
- history of chronic sinusitis (more than 90 days of respiratory symptoms in this or the previous respiratory season)
- girls who have begun menstruating

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
United States, Wisconsin | |
UW Health Pediatrics (Park St) | |
Madison, Wisconsin, United States, 53715 | |
UW Health Pediatrics (WestTowne) | |
Madison, Wisconsin, United States, 53717 |
Principal Investigator: | Ellen R Wald, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT01166945 |
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 |
Child Child, preschool Sinusitis Antimicrobial agents |
Sinusitis Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Amoxicillin Clavulanic Acid |
Clavulanic Acids Amoxicillin-Potassium Clavulanate Combination Anti-Bacterial Agents Anti-Infective Agents beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |