Treatment of Acute Sinusitis
Condition: Acute Respiratory Infections; Acute Rhinosinusitis
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the symptom relief provided by 5 cold medicines versus the symptom
      relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who
      have sinus infections. Treatment with amoxicillin may be more effective than treatment with
      cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus
      infections will participate in this study for 28 days. Volunteers will receive a 10-day
      course of either amoxicillin or placebo (substance containing no medication). In addition,
      all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and
      cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10,
      and 28 following the start of treatment. The study will look at quality of life factors such
      as change in functional status (ability to perform daily activities) and symptoms, recurrence
      of the infection, satisfaction with care, and the direct costs of treatment.
    

Detailed description: 
      The primary objective of this phase IV, randomized, placebo controlled clinical trial is to
      determine the incremental effect of amoxicillin treatment compared with symptomatic
      treatments on disease-related quality of life in adults with clinically diagnosed acute
      bacterial rhinosinusitis. The secondary objective is to determine the incremental effect of
      amoxicillin treatment compared with symptomatic treatments on functional status, symptoms,
      disease recurrence, satisfaction with treatment, and direct costs of treatment in adults with
      clinically diagnosed acute bacterial rhinosinusitis. The tertiary objective is to identify
      prognostic indicators for clinical improvement with antibiotic treatment in adults with
      clinically diagnosed acute bacterial rhinosinusitis. Two hundred adult subjects, 18 to 70
      years old, who meet the recommended criteria for acute bacterial rhinosinusitis, will be
      enrolled from 8 practice sites. Subjects will be randomized to receive a 10-day course of
      either amoxicillin or placebo. In addition, all subjects will receive an analgesic, an oral
      decongestant, a nasal saline spray, and an antitussive agent. Subject outcomes will be
      assessed by telephone interview at 0, 3, 7, 10, and 28 days. The primary outcome is the
      disease-specific quality of life at Day 3 measured with the SNOT-16, a validated evaluative
      instrument. Secondary outcomes include change in functional status and symptoms, disease
      recurrence, satisfaction with care and the direct costs of treatment. Tertiary outcome
      measures include possible subject and disease-related factors that predict clinical
      improvement with antibiotic treatment at Day 3 for use in future studies to aid clinical
      decision-making.
    

Intervention name(s): Acetaminophen; Amoxicillin; Dextromethorphan hydrobromide with guaifenesin; Guaifenesin; Pseudoephedrine Sustained Action; Saline spray (0.65%)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Symptomatic treatment:
Dose: 500mg every 4 to 6 hours for pain or fever; Intervention drug:
Dose: 500mg tid for 10 days; Symptomatic treatment:
Dose: 10mls every 4 to 6 hours for cough; Symptomatic treatment:
Dose: 600mg every 12 hours to thin secretions; Symptomatic treatment:
Dose: 120mg every 12 hours for nasal congestion; Symptomatic treatment:
Dose: 2 squeezes per nostril as needed for nasal congestion
Other intervention name(s): Tylenol; Amoxil; Robitussin; Mucinex OTC; Sudafed; Ocean Nasal Spray
Intervention MeSH terms: Acetaminophen; Amoxicillin; Phenylpropanolamine; Pseudoephedrine; Ephedrine; Dextromethorphan; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rhinosinusitis, sinusitis, amoxicillin