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

University of Wisconsin (UW)

Status: Completed

Conditions: Sinusitis

Treatments: Drug: Placebo; Drug: Amoxicillin-Potassium Clavulanate Combination

Study type: Interventional

Funder types: Other

Identifiers

NCT01166945

2015-0452

130933 (Other Identifier)

H-2010-0129 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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98 participants in 2 patient groups, including a placebo group

Short Course

Placebo Comparator group

Description:

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

Treatment:

Drug: Amoxicillin-Potassium Clavulanate Combination

Drug: Placebo

Long Course

Active Comparator group

Description:

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

Treatment:

Drug: Amoxicillin-Potassium Clavulanate Combination