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

This study is currently recruiting participants.
Verified September 2017 by Nader Shaikh, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT02554383
First Posted: September 18, 2015
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Nader Shaikh, University of Pittsburgh
September 8, 2015
September 18, 2015
October 2, 2017
February 2016
September 2020   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02554383 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Costs of Care [ Time Frame: From Day 1 after randomization to Day 18 ]
Direct medical costs and indirect medical costs will be obtained.
Same as current
 
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Sinusitis
  • Respiratory Tract Infections
  • Drug: Amoxicillin-clavulanate
    Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
    Other Name: Augmentin-Extra strength
  • Drug: Placebo
    placebo made to match the study antibiotic given twice a day orally for 10 days
  • Active Comparator: Treatment A
    Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
    Intervention: Drug: Amoxicillin-clavulanate
  • Placebo Comparator: Treatment B
    Placebo made to match the study antibiotic will be taken bid orally for 10 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
688
September 2020
September 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years to 11 Years   (Child)
No
Contact: Jennifer P Nagg, RN, MS 412-692-8586 jennifer.nagg@chp.edu
Contact: Michelle Burke, MS
United States
 
 
NCT02554383
PRO15030187
U01AI118506 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Yes
Nader Shaikh, University of Pittsburgh
University of Pittsburgh
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Nader Shaikh, MPH, MD University of Pittsburgh
Principal Investigator: Ellen R Wald, MD University of Wisconsin, American Family Children's Hospital
University of Pittsburgh
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP