Chronic Suppurative Otitis Media
Conditions
Interventions
Sponsors
zambart
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with CSOM (otorrhoea from the middle ear for >2 weeks through a perforated eardrum)
Exclusion criteria
Exclusion criteria: Treated for ear infection or received antibiotics for any other disease in the previous 2 weeks Other ear problems, e.g., external ear infection, tumours, or craniofacial malformation - History of otologic surgery - History or presence of cholesteatoma - Exposure to any investigational agent within 90 days before study entry - Presence of a tympanostomy tube - Known allergy to study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dry ear by week 2, confirmed by video otoscopy (i.e., the proportion of participants achieving resolution of ear discharge) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in hearing threshold (decibels/frequencies, via audiograms) - Self-reported time taken for the ear to dry (patient/caregiver journaling) - Recurrence rate of otorrhoea at 3 or 6 months - Mean change in tympanic membrane perforation size - Microbial resistance patterns in persistent or recurrent otorrhoea - Adverse effects of treatments (dizziness, tinnitus, pain, irritation, skin reaction) | — |
Countries
Zambia
Contacts
Public ContactKwame Shanaube
Executive Director
Outcome results
None listed