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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nader Shaikh; University of Pittsburgh
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clavulanic Acid; Clavulanic Acids

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