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

NCT ID: NCT01166945

Last Updated: 2019-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2016-02-29

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.

Conditions

Sinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Short Course

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

Group Type: PLACEBO_COMPARATOR

Amoxicillin-Potassium Clavulanate Combination

Intervention Type: 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.

Placebo

Intervention Type: 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.

Long Course

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

Group Type: ACTIVE_COMPARATOR

Amoxicillin-Potassium Clavulanate Combination

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

there are none; there are none

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellen R Wald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

UW Health Pediatrics (Park St)

Madison, Wisconsin, United States

UW Health Pediatrics (WestTowne)

Madison, Wisconsin, United States

Countries

United States

Related Links

http://www.pediatrics.wisc.edu/research/

University of Wisconsin-Madison Department of Pediatrics Research Information

Other Identifiers

130933

Identifier Type: OTHER

Identifier Source: secondary_id

H-2010-0129

Identifier Type: OTHER

Identifier Source: secondary_id

2015-0452

Identifier Type: -

Identifier Source: org_study_id