Randomised trial of treatment of chronic suppurative otitis media (CSOM) in Kenyan children
| ISRCTN | ISRCTN86106121 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86106121 |
| Protocol serial number | N/A |
| Sponsor | Liverpool School of Tropical Medicine (UK) |
| Funder | Thrasher Research Fund (USA) |
- Submission date
- 25/11/2008
- Registration date
- 17/12/2008
- Last edited
- 16/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ian Mackenzie
Scientific
Scientific
Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom
| Phone | +44 (0)151 705 3144 |
|---|---|
| macken34@liv.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind, two-group comparative randomised placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Treatment of chronic suppurative otitis media (CSOM) in Kenyan children: a double blind, two-group comparative randomised placebo controlled trial |
| Study acronym | COMIGS |
| Study objectives | The addition of oral zinc sulphate supplements (20 mg elemental zinc/day) to current best treatment (aural antibiotics instilled after ear cleaning) is more effective than current best treatment alone in time to resolution of chronic suppurative otitis media (CSOM) in children. |
| Ethics approval(s) | Pending as of 25/11/2008: 1. University of Nairobi Ethics Committee: submitted 18/11/2008 2. Liverpool School of Tropical Medicine Ethics Committee: submitted 20/11/2008 |
| Health condition(s) or problem(s) studied | Chronic suppurative otitis media (CSOM) |
| Intervention | 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 aural ciprofloxacin 0.3% ear drops |
| Intervention type | Supplement |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Resolution of aural discharge |
| Completion date | 01/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Sex | All |
| Target sample size at registration | 432 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2009 |
| Date of final enrolment | 01/02/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
- Kenya
Study participating centre
Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom
L3 5QA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/05/2022: No publications found, all search options exhausted, study status unverified.
