Randomised trial of treatment of chronic suppurative otitis media (CSOM) in Kenyan childre
Not Applicable
Completed
- Conditions
- Chronic suppurative otitis media (CSOM)Ear, Nose and ThroatSuppurative and unspecified otitis media
- Registration Number
- ISRCTN86106121
- Lead Sponsor
- iverpool School of Tropical Medicine (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 432
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method <br> 1. Resolution of aural discharge<br> 2. Any change of 10 decibels or more over the speech frequencies<br> 3. Safety profiles of the two treatments<br><br> Children will be reviewed at 6, 10 and 16 weeks.<br>