SINUSITIS STUDIES
























ADULTS - FIRST LINE
Standard (IDSA recommendations)

High-dose therapy - recommended when one of the following is present: geographic regions with high endemic rates (≥10%) of invasive penicillin-resistant S. pneumoniae; those with severe infection (e.g. fever ≥ 39°C [102°F], and threat of suppurative complications); age > 65 years; recent hospitalization; antibiotic use within the past month; immunocompromised [3]
ADULTS - SECOND LINE (PENICILLIN ALLERGIC)

CHILDREN - FIRST LINE
Standard (AAP recommendations)
  • Amoxicillin 45 mg/kg per day in 2 divided doses for a minimum of 10 days

High-dose therapy - recommended in communities with a high prevalence of nonsusceptible S pneumoniae (>10%, including intermediate- and high-level resistance)
  • Amoxicillin 80 - 90 mg/kg per day in 2 divided doses (maximum of 2 g per dose) for a minimum of 10 days

Moderate-to-severe illness - defined as the presence of one of the following: < 2 years old; attending child care; recently been treated with an antimicrobial
  • Amoxicillin-clavulanate (Augmentin®) 80 – 90 mg/kg per day of the amoxicillin component with 6.4 mg/kg per day of clavulanate in 2 divided doses with a maximum of 2 g per dose for a minimum of 10 days [4]
CHILDREN - SECOND LINE (PENICILLIN ALLERGIC)
  • Cefdinir* 7 mg/kg every 12 hours or 14 mg/kg once daily for a minimum of 10 days
  • Cefpodoxime (Vantin®)* 5 mg/kg every 12 hours (Max 200 mg/dose) for a minimum of 10 days
  • Cefuroxime (Ceftin®)* 30 mg/kg/day divided twice a day (Max 1,000 mg/day) for a minimum of 10 days [4,5]

Young children (< 2 years old)





Study Criteria Intervention Primary outcome Results
Oral Steroids
vs
Placebo

CMAJ
2012

PubMed abstract
Inclusion criteria:
  • Symptoms for at least 5 days
  • At least 2 of the following:
    • Nasal discharge (posterior or anterior) or nasal congestion
    • Facial pressure or pain, or pain when chewing

Exclusion criteria:
  • Temp > 101.3° after 5 days
  • Recurrent sinusitis
Group 1 (93 patients) - prednisolone 30 mg/day for 7 days

Group 2 (92 patients) - placebo for 7 days

  • About 19% in each group received antibiotics
  • About 18% in each group received nasal steroids
Resolution of facial pain or pressure on day 7 as recorded in a patient diary Primary outcome
Group 1 - 62.5%
Group 2 - 55.8%
Diff - 6.7%, (95%CI -7.9 - 21.2%), Nonsignificant

Other
  • Adverse events between groups did not differ significantly
  • Duration of symptoms did not differ significantly

Study Criteria Intervention Primary outcome Results
Amoxicillin
vs
Placebo

JAMA
2012

PubMed abstract
Inclusion criteria (all must be present):
  • History of maxillary pain or tenderness in the face or teeth
  • Purulent nasal secretions
  • Rhinosinusitis symptoms for ≥ 7 days that were not improving; or rhinosinusitis symptoms for < 7 days that had worsened after initial improvement
Group 1 (85 patients) - Amoxicillin 500 mg 3 times a day for 10 days

Group 2 (81 patients) - Placebo for 10 days

  • All patients also received guaifenesin, dextromethorphan, pseudoephedrine, and saline nasal spray
Improvement in disease-specific quality of life after 3 to 4 days of treatment assessed with the Sinonasal Outcome Test-16 (minimally important difference of 0.5 units on a 0-3 scale) Primary outcome
There was no significant difference between the groups in the improvement of symptom score at day 3. On day 7, the amoxicillin group was significantly better. On day 10, there was no significant difference.

Other
  • There was no significant difference in adverse events

Study Criteria Intervention Primary outcome Results
Amoxicillin ± nasal steroid
vs
Placebo

JAMA
2007

PubMed abstract
Inclusion criteria:
Must have 2 or more of the following:
  • Purulent nasal discharge predominantly on one side
  • Sinus pain predominantly on one side
  • Purulent nasal discharge on both sides, and pus on inspection inside the nose
Group 1 (53 patients) - Amoxicillin 500 mg 3 times a day for 7 days and nasal steroid for 10 days

Group 2 (60 patients) - Amoxicillin 500 mg 3 times a day for 7 days and placebo spray

Group 3 (64 patients) - Placebo and nasal steroid for 10 days

Group 4 (63 patients) - Double placebo
Proportion clinically cured at day 10 using patient symptom diaries and the duration and severity of symptoms Primary outcome
  • The proportions of patients with symptoms lasting 10 or more days were 29% for amoxicillin vs 33.6% for no amoxicillin (odds ratio, 0.99; CI 0.57-1.73)
  • The proportions of patients with symptoms lasting 10 or more days were 31.4% for nasal steroid vs 31.4% for no steroid (odds ratio, 0.93; CI 0.54-1.62)
  • There were no significant interactions

Study Criteria Intervention Primary outcome Results
Augmentin®
vs
Placebo

Archives of IM
2003

PubMed abstract
Inclusion criteria:
  • History of purulent nasal discharge and sinus pain for ≥ 48 hours
Group 1 (125 patients) - Augmentin® 875/125 twice a day for 6 days

Group 2 (127 patients) - Placebo for 6 days

All patients received a nasal decongestant
The primary outcome was time to cure. Cure was defined as no activity restriction due to symptoms. Patients were evaluated on days 7 and 14. Primary outcome
  • There was no significant difference between the groups in time to cure at days 7 and 14
  • In a subgroup analysis that only included patients with pus on rhinoscopy, there was no significant difference between groups on days 7 and 14
  • 15% of the patients in the placebo group crossed over to antibiotics
  • 8.8% of the patients in the Augmentin® group received open treatment (unblinded)

Other
  • The Augmentin® group was more likely to have diarrhea on day 7

Study Criteria Intervention Primary outcome Results
Amoxicillin
vs
Placebo
(positive sinus X-ray)

Lancet
1997

PubMed abstract
Inclusion criteria:
Sinusitis symptoms and a positive sinus X-ray that showed mucosal swelling of more than 5 mm, complete shadowing, or a fluid level.
Group 1 (108 patients) - Amoxicillin 750 mg three times a day for 7 days

Group 2 (106 patients) - Placebo for 7 days
The primary outcome was cure rate after 2 weeks and symptom scores after 1 and 2 weeks. Cure was defined as being symptom-free. Primary outcome
  • After 2 weeks, symptoms had improved substantially or disappeared in 83% of patients in the amoxicillin group and 77% of patients in the placebo group (nonsignificant, p-value=0.20). Amoxicillin did not influence the clinical course of maxillary sinusitis nor the frequency of relapses during the 1-year follow-up
  • Radiographs had no prognostic value, nor were they an effect modifier
  • The mean duration of symptoms in both groups before treatment was 2.2 weeks

Other
  • Side effects were recorded in 28% of patients given amoxicillin, and in 9% of those taking placebo (p< 0·01)