Overview

This trial is active, not recruiting.

Condition sinusitis
Treatments amoxicillin-potassium clavulanate combination, placebo
Sponsor University of Wisconsin, Madison
Collaborator Thrasher Research Fund
Start date November 2010
End date April 2016
Trial size 98 participants
Trial identifier NCT01166945, 130933

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Short course (5 days) of antimicrobial therapy and placebo for next 9 days.
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.
(Active Comparator)
Long course (14 days) of antimicrobial therapy.
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.

Primary Outcomes

Measure
Comparison of short course to long course antimicrobials.
time frame: 2 years

Eligibility Criteria

Male or female participants from 1 year up to 10 years old.

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

Additional Information

Official title Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
Principal investigator Ellen R Wald, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.