Chronic suppurative otitis media (CSOM) Ear, Nose and Throat Suppurative and unspecified otitis media
Conditions
Interventions
1. Six weeks of weekly oral zinc sulphate supplement (20 mg) together with 10 days of aural ciprofloxacin 0.3% ear drops
2. Six weeks of weekly oral placebo together with 10 days of au
Sponsors
Liverpool School of Tropical Medicine (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 5 years or older, either sex 2. Presence of purulent aural discharge for 14 days or longer 3. Presense of pus in the external ear canal on otoscopy 4. Perforation of the tympanic membrane
Exclusion criteria
Exclusion criteria: 1. Treated for ear infection or received antibiotics for any other disease in the previous 2 weeks 2. Other ear problems, e.g. pre-exiting ear disease or anatomical abnormalities 3. Foreign body or ear wax that is not able to be removed 4. Known allergy to study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing of the tympanic membrane at 42 days with no evidence of perforation on otoscopy, tympanometry or the Rinne Test has changed from negative to positive. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Resolution of aural discharge 2. Any change of 10 decibels or more over the speech frequencies 3. Safety profiles of the two treatments Children will be reviewed at 6, 10 and 16 weeks. | — |
Countries
England, Kenya, United Kingdom
Outcome results
None listed