Sinusitis - URTI Respiratory
Conditions
Interventions
Participants are randomised to either:
1. Immediate antibiotics (current usual treatment in primary care)
2. Advice to do nasal irrigation for up to 3 weeks with a ‘back-up’ or delayed antibiotic pres
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The researchers pragmatically define acute sinusitis as having sinus discomfort and at least 2 other symptoms (2 of: patient-reported nasal obstruction, patient-reported purulent nasal discharge, or pus seen in the nasal cavity on inspection by the clinician). They do not propose using prior duration (e.g. the requirement for at least 7 days without improvement in the Canadian guidelines) since there is no good evidence for a particular cut-off, and their aim is to help people who are currently being treatment with antibiotics for sinusitis, many of whom present with 7 days.
Exclusion criteria
Exclusion criteria: 1. Inability to complete outcomes (reduced capacity: dementia, severe uncontrolled mental illness; terminal illness etc) 2. Head/neck cancer 3. HIV 4. Immune-suppressive treatment 5. Cystic fibrosis 6. Pregnancy/breastfeeding 7. Other nasal disorders e.g. polyps; poor gag/swallow reflexes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Antibiotic use measured using patient-reported symptom diary, completed over four weeks or until symptoms resolve. 2. Duration of moderately bad symptoms measured using a validated symptom diary; variables (using 7-point Likert scales): nasal blockage, discharge, unpleasant taste/smell, facial pain, pain on bending, impaired activities, generally unwell, sleep disturbance. Completed over four weeks or until symptoms resolve. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptom duration until little/no problem, measured using patient-reported symptom diary, completed over four weeks or until symptoms resolve 2. Mean symptom score measured using patient-reported symptom diary, completed over four weeks or until symptoms resolve 3. Development of new/worsening symptoms measured using patient-reported symptom diary, completed over four weeks or until symptoms resolve 4. Health-related quality of life measured using EQ5D, completed over four weeks or until symptoms resolve 5. Reconsultations/resource use during the next month measured using patient note reviews conducted by staff at the surgeries | — |
Countries
England, United Kingdom
Contacts
Public ContactTammy Thomas
Outcome results
None listed