Contact information
Type
Scientific
Primary contact
Dr Ian Mackenzie
ORCID ID
Contact details
Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom
+44 (0)151 705 3144
macken34@liv.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Treatment of chronic suppurative otitis media (CSOM) in Kenyan children: a double blind, two-group comparative randomised placebo controlled trial
Acronym
COMIGS
Study hypothesis
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
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
Study design
Double blind, two-group comparative randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Zinc sulphate supplement, ciprofloxacin
Primary outcome measures
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
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.
Overall trial start date
01/02/2009
Overall trial end date
01/02/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
432 school age children (5 years and older)
Participant 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
Recruitment start date
01/02/2009
Recruitment end date
01/02/2010
Locations
Countries of recruitment
Kenya
Trial participating centre
Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom
Sponsor information
Organisation
Liverpool School of Tropical Medicine (UK)
Sponsor details
Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)151 705 3144
macken34@liv.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Thrasher Research Fund (USA)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary