Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children

Sinusitis Clinical Trial

Official title:

Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166945
• Other study ID #: 2015-0452
• Secondary ID: 130933H-2010-012
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: February 2016

Study information

• Verified date: June 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Sinusitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UW Health Pediatrics (Park St)	Madison	Wisconsin
United States	UW Health Pediatrics (WestTowne)	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	at 10 days and at 20 days
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	Baseline and 30 days

External Links

•   University of Wisconsin-Madison Department of Pediatrics Research Information