Condition category
Ear, Nose and Throat
Date applied
25/11/2008
Date assigned
17/12/2008
Last edited
17/12/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.liv.ac.uk/lstm

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

Publication citations

Additional files

Editorial Notes