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

NCT01166945 | Completed Results

• 3 other identifiers: 2015-0452130933H-2010-0129
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

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.

Conditions

Sinusitis

Keywords

Child; Child, preschool; Sinusitis; Antimicrobial agents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline

  Baseline and 30 days

Study Arms (2)

Short Course

PLACEBO COMPARATOR

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

Drug: Amoxicillin-Potassium Clavulanate Combination; Drug: Placebo

Long Course

ACTIVE COMPARATOR

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

Drug: Amoxicillin-Potassium Clavulanate Combination

Interventions

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.

Also known as: there are none

Long Course; Short Course

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.

Also known as: there are none

Short Course

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Thrasher Research Fund: collaborator

Study Sites (2)

UW Health Pediatrics (Park St)

Madison, Wisconsin, 53715, United States

Location

UW Health Pediatrics (WestTowne)

Madison, Wisconsin, 53717, United States

Location

Related Links

• University of Wisconsin-Madison Department of Pediatrics Research Information

MeSH Terms

Conditions

Sinusitis

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

Total number of participants experiencing adverse events is unavailable, the maximum number of participants is reported. The possible range for Arm A is 18-44, the possible range for Arm B is 21-47.

Results Point of Contact

• Title: Ellen Wald, MD
• Organization: University of Wisconsin School of Medicine and Public Health

erwald@pediatrics.wisc.edu

608-263-8558

Study Officials

• Ellen R Wald, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 21, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 10, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)