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Completed

NCT Number: NCT01166945

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

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.

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Key information

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW Health Pediatrics (Park St), Madison, Wisconsin, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin-Potassium Clavulanate Combination

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.

Other names: there are none

Placebo

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.

Other names: there are none

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Thrasher Research Fund

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jul 21, 2010
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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