Randomised trial of treatment of chronic suppurative otitis media (CSOM) in Kenyan children

ISRCTN	ISRCTN86106121
DOI	https://doi.org/10.1186/ISRCTN86106121
Secondary identifying numbers	N/A

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

Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom

Phone	+44 (0)151 705 3144
Email	macken34@liv.ac.uk

Study information

Study design	Double blind, two-group comparative randomised placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	01/02/2009
Completion date	01/02/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Sex	Both
Target number of participants	432 school age children (5 years and older)
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

England
Kenya
United Kingdom

Study participating centre

Liverpool School of Tropical Medicine

Liverpool
L3 5QA
United Kingdom

Sponsor information

Liverpool School of Tropical Medicine (UK)
Hospital/treatment centre

Pembroke Place
Liverpool
L3 5QA
England
United Kingdom

Phone	+44 (0)151 705 3144
Email	macken34@liv.ac.uk
Website	http://www.liv.ac.uk/lstm
"ROR"	https://ror.org/03svjbs84

Funders

Funder type

Charity

Thrasher Research Fund (USA)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): TRF
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Editorial Notes

16/05/2022: No publications found, all search options exhausted, study status unverified.