Phase 3
Completed N=515
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
Source: ClinicalTrials.gov NCT02554383 ↗Enrolled (actual)
515
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: 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
◆ Published Evidence
Established
40citations · ~13 / year
Identifying Children Likely to Benefit From Antibiotics for Acute Sinusitis: A Randomized Clinical Trial.
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.
Linked Publications
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Identifying Children Likely to Benefit From Antibiotics for Acute Sinusitis: A Randomized Clinical Trial.
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 |
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) and the linked publication. 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. Informational only — not medical advice.