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Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Nader Shaikh, University of Pittsburgh
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Nader Shaikh, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02554383
First received: September 8, 2015
Last updated: September 15, 2017
Last verified: September 2017
  Purpose
The objective of this trial is to determine whether certain subgroups of children with acute sinusitis exist in whom antibiotic therapy can be appropriately withheld.

Condition Intervention Phase
Sinusitis Respiratory Tract Infections Drug: Amoxicillin-clavulanate Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?

Resource links provided by NLM:


Further study details as provided by Nader Shaikh, University of Pittsburgh:

Primary Outcome Measures:
  • Symptom Severity [ Time Frame: From Day 1 after randomization until day 11 ]
    Treatment effect will be measured primarily using the validated Pediatric Rhinosinusitis Symptom Scale (PRSS) which will be administered every evening as an electronic diary.


Secondary Outcome Measures:
  • Treatment Failure [ Time Frame: From Day 1 after randomization to day 18 ]
    • Worsening at any time-PRSS score increased by >20% from entry.
    • No change by 48 hours-PRSS score decreased by <2 points from entry (Day 1) to Day 3.
    • Failure to improve significantly by 72 hours-PRSS score decreased by <20% from entry (Day 1) to Day 4.
    • Still symptomatic (PRSS score ≥50% of entry score) at the time of the end-of-study follow-up visit (Days 12 to 18).

  • Number of Participants with Acute Otitis Media [ Time Frame: From Day 1 after randomization to day 11 ]
    Acute symptoms and a bulging tympanic membrane on Days 1 to 11.

  • Number of Participants who received systemic antibiotics for any indication [ Time Frame: From Day 1 after randomization to day 11 ]
    Receipt of an antibiotic (other than the assigned study medication) on Days 1 to 11 for any indication.

  • Adverse Events [ Time Frame: From Day 1 after randomization to Day 18 ]
    The proportions of children experiencing adverse events will be compared (protocol-defined diarrhea and Moderate or severe rash or other severe AE). Protocol-defined diarrhea will be defined as the occurrence of ≥3 watery stools in 1 day or 2 watery stools per day for 2 consecutive days, and will be tracked in the daily diary.

  • Proportion Compliant with Study Product [ Time Frame: From Day 1 after randomization to Day 18 ]
    Compliance - In the daily diary, the investigators will ask participants to record whether they administered the doses of study product. Administration of ≥70% of the doses will be considered compliant.


Other Outcome Measures:
  • Costs of Care [ Time Frame: From Day 1 after randomization to Day 18 ]
    Direct medical costs and indirect medical costs will be obtained.


Estimated Enrollment: 688
Study Start Date: February 2016
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment A
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
Drug: Amoxicillin-clavulanate
Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
Other Name: Augmentin-Extra strength
Placebo Comparator: Treatment B
Placebo made to match the study antibiotic will be taken bid orally for 10 days
Drug: Placebo
placebo made to match the study antibiotic given twice a day orally for 10 days

Detailed Description:

The current clinical practice guideline from the American Academy of Pediatrics for the Diagnosis and Management of Acute Bacterial Sinusitis recommends that the diagnosis of acute sinusitis is made when symptoms of an upper respiratory infection (URI) persist beyond 10 days without showing signs of improvement (persistent presentation), when symptoms appear to worsen (on the 6th to 10th day) after a period of improvement (worsening presentation), or when both high fever and purulent nasal discharge are present concurrently for at least 3 consecutive days (severe presentation). In studies to date, children with persistent and worsening presentations comprise >95% of cases. The investigators preliminary data and the available literature suggest that only a subset of children being diagnosed with acute sinusitis on the basis of current criteria are likely to have bacterial disease. This is not entirely surprising because current criteria rely solely on the duration and the quality of respiratory tract symptoms (which are both common and non-specific). Accordingly, it seems likely that many children currently being diagnosed as having acute sinusitis actually have an uncomplicated upper respiratory infection. This is important because acute sinusitis is one of the most common diagnoses for which antimicrobials are prescribed for children in the United States, accounting for 7.9 million prescriptions annually. A critical need thus exists to establish which subgroups of children currently being diagnosed with acute sinusitis actually benefit from antimicrobial therapy.

The objective of this trial is to determine whether certain subgroups of children with acute sinusitis exist in whom antibiotic therapy can be appropriately withheld. This objective will be achieved by conducting a large, randomized, double-blind, placebo-controlled clinical trial in children 2 to 12 years of age with persistent or worsening presentations of acute sinusitis. Based on the investigators preliminary data, the investigators hypothesize that only certain subgroups of children currently being treated for acute sinusitis actually benefit from antimicrobial therapy. By identifying, in a large placebo-controlled trial, subgroups of children who respectively do and do not benefit from antimicrobial therapy, the investigators will be better able to determine which children should be classified as having acute bacterial sinusitis. Accordingly, the results of this trial may impact not only the treatment guidelines for acute sinusitis but also the diagnostic criteria, and will help ensure that, to the extent possible, antibiotic use is limited to appropriate patients. This, in turn, will maximize the likelihood of achieving optimal outcomes and minimize the risk of promoting antibiotic resistance.

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets criteria for "persistent" or "worsening" presentations of sinusitis
  • Baseline score ≥9 on the Pediatric Rhinosinusitis Symptom Scale

Exclusion Criteria:

  • Severe presentation (≥3 days of colored nasal discharge and fever ≥39°C
  • Asthma/allergic rhinitis explains symptoms
  • Allergy to amoxicillin-clavulanate
  • Immotile cilia syndrome
  • Cystic fibrosis
  • Immunodeficiency
  • Parental inability to read/write English or Spanish
  • Other concurrent infection (e.g., pneumonia, acute otitis media, streptococcal pharyngitis)
  • Systemic toxicity
  • Wheezing on exam
  • Antibiotic use within 15 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02554383

Contacts
Contact: Jennifer P Nagg, RN, MS 412-692-8586 jennifer.nagg@chp.edu
Contact: Rebecca Stallings, BA 412-692-9638 rebecca.stallings@chp.edu

Locations
United States, Kentucky
Kentucky Pediatric/Adult Research Recruiting
Bardstown, Kentucky, United States, 40004
Contact: Marty Osbourn, RN CCRC    502-349-1569    mpatterson.kpar@bardstowncable.net   
United States, New York
Legacy [ediatrics Not yet recruiting
Rochester, New York, United States, 14618
Contact: Janet Casey, MD       research.legacypeds@gmail.com   
United States, Pennsylvania
The Children's Hospital of Philadelphia Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Jennifer P Nagg, RN, MS    412-692-8586    jennifer.nagg@chp.edu   
Contact: Rebecca Stallings, BA    412-692-9638    rebecca.stallings@chp.edu   
United States, West Virginia
WVU Medicine Pediatric and Adolescent Group Practice Not yet recruiting
Morgantown, West Virginia, United States, 26501
Contact: Michelle Shaffer, CCRP    304-893-1039    mmshaffer@hsc.wvu.edu   
Principal Investigator: Timothy Lefeber, MD         
United States, Wisconsin
American Family Children's Hospital Recruiting
Madison, Wisconsin, United States, 53792
Contact: Jody Belling, RN, MSN    608-265-1894    jdbelling@pediatrics.wisc.edu   
Contact: Cherie E Schommer, BA    608-262-2631    ceschommer@pediatrics.wisc.edu   
Sponsors and Collaborators
University of Pittsburgh
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Nader Shaikh, MPH, MD University of Pittsburgh
Principal Investigator: Ellen R Wald, MD University of Wisconsin, American Family Children's Hospital
  More Information

Responsible Party: Nader Shaikh, Associate Professor of Pediatrics, University of Pittsburgh School of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02554383     History of Changes
Other Study ID Numbers: PRO15030187
U01AI118506 ( U.S. NIH Grant/Contract )
Study First Received: September 8, 2015
Last Updated: September 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Nader Shaikh, University of Pittsburgh:
pediatrics
antibiotics
placebo

Additional relevant MeSH terms:
Respiratory Tract Infections
Sinusitis
Infection
Respiratory Tract Diseases
Paranasal Sinus Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 19, 2017