Phase 3
N=515
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
Sinusitis · Respiratory Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT02554383 ↗Enrolled (actual)
515
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment — 17.3; 18.6; 13.9; 16.6 Score on a scale — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Amoxicillin-clavulanate (Drug); Placebo (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Nader Shaikh
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment |
17.3; 18.6; 13.9; 16.6; 11.8; 13.9 | 0.02 sig |
| PRIMARY The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment |
18.6; 19.0; 14.8; 16.6; 12.1; 13.7 | 0.37 |
| SECONDARY The Distribution of Children Experiencing Treatment Failure (TF) |
76; 111; 178; 145 | 0.003 sig |
| SECONDARY The Distribution of Children Developing Acute Otitis Media (AOM) Over the First 10 Days of Follow-up |
0; 8; 251; 248 | .007 sig |
| SECONDARY The Distribution of Children Receiving a Systemic Antibiotic Over the First 10 Days of Follow-up |
34; 66; 217; 190 | <0.001 sig |
| SECONDARY The Distribution of Children for Whom Diarrhea or Generalized Rash Was Reported |
31; 13; 223; 243 | 0.004 sig |
| SECONDARY The Distribution of Children Compliant With Study Medication |
212; 221; 14; 13 | 0.75 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02554383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.