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

Completed · Phase 3 · Has a placebo group

Conditions studied: Sinusitis, Respiratory Tract Infections

In brief

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.

Key facts

Study ID

NCT02554383

Run by

Nader Shaikh

People needed

515

Starts

2016-02-01

Expected to finish

2023-03-09

Last updated by the study team

2023-06-29

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Kentucky Pediatric/Adult Research — Bardstown, Kentucky, United States
• Cyn3rgy Research — Gresham, Oregon, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• WVU Medicine Pediatric and Adolescent Group Practice — Morgantown, West Virginia, United States
• American Family Children's Hospital — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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