Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201512001370307 Date of Approval: 29/11/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Randomised placebo-controlled trial of oral doxycycline to reduce recurrent trachomatous trichiasis
Official scientific title Randomised placebo-controlled trial of oral doxycycline to reduce recurrent trachomatous trichiasis
Brief summary describing the background and objectives of the trial Trachomatous trichiasis affects about 7 million people worldwide. Trachoma is caused by Chlamydia trachomatis. Surgery is performed to correct it. However, the trichiasis frequently returns. This is partly thought to be due to post operative scarring. Doxycycline is an antibiotic with anti-chlamydial, anti-inflammatory and anti-scarring protperties. We aim to test the hypothesis that a one month course of post-operative doxycycline can reduce the chance of recurrent trichiasis throught its anti-scarring properties. This is a prospective double-masked, randomised placebo-controlled clinical trial. We will recruit 1000 participants (individuals with un-operated trachomatous trichiasis) and provide surgical treatment for their trichiasis. Immediately after the surgery, the study participants will be randomised to take either oral doxycycline or placebo for 4 weeks. Follow-up assessments will be conducted at 1 week, 1 month, 6 months and 12 months, to determine the outcome. Conjunctival swab samples will be collected at each time point for the detection of infection and gene expression analysis to investigate the immunofibrogenic processes involved.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Surgery,Trachomatous trichiasis
Sub-Disease(s) or condition(s) being studied trachomatous trichiasis
Purpose of the trial Treatment: Other
Anticipated trial start date 14/12/2015
Actual trial start date 21/12/2015
Anticipated date of last follow up 30/06/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, centre, or previous treatment are used in the stratification (please specify factors used for stratification) The doxycycline and placebo and the packaging are of identical appearance Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Doxycycline 100mg once a day 28 days Doxycycline 500
Control Group Placebo One capsule, once a day 28 days Placebo 500 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Trachomatous Trichiasis with tarsal conjunctival scarring 2. Adults (>18 years of age) 3. Agree to be randomly allocated to receive doxycycline or placebo following surgery 4. Agree to re-examination at one week, one, six and twelve months after surgery 1. Age less than 18 years 2. Pregnant or breast-feeding women 3. Previous eyelid surgery 4. Medically unfit, BP systolic >170, diastolic >110 5. People with known history of hypersensitivity/allergy to Doxycycline or Tetracycline 6. Presence of contra-indication to doxycycline usage o Taking warfarin o Taking sulphonylurea based medication for diabetes o Pre-existing known liver or renal impairment o Myasthenia gravis 7. Patients with trichiasis from other eyelid pathologies, such as: o Blepharitis o Steven Johnson syndrome o Burn o Trauma o Eyelid muscle laxity due to aging o Herpes zoster o Ocular cicatricial pemphigoid 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/09/2014 London School of Hygiene & Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E7HT United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/01/2015 Emory University IRB
Ethics Committee Address
Street address City Postal code Country
1599 Clifton Road Atlanta 30322 United States of America
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/06/2015 Federal Democratic Republic of Ethiopia Ministry of Science and Technology National Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Addis Ababa Ethiopia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/09/2015 Food, Medicine and Health Care Administration and Control Authority of Ethiopia
Ethics Committee Address
Street address City Postal code Country
Addis Ababa Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Recurrent trichiasis following surgery 1 month 6 months 12 months
Secondary Outcome Severity of recurrent trichiasis 1 month 6 months 12 months
Primary Outcome Recurrent trichiasis following surgery 1 month 6 months 12 months
Secondary Outcome Severity of recurrent trichiasis 1 month 6 months 12 months
Secondary Outcome Conjunctival inflammation 1 month 6 months 12 months
Secondary Outcome Change in corneal opacification 1 month 6 months 12 months
Secondary Outcome Change in visual acuity 1 month 6 months 12 months
Secondary Outcome Complication Rates 1 month 6 months 12 months
Secondary Outcome Patient perspectives on the results of surgery 12 months
Secondary Outcome Side effects 1 month 6 months 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Carter Center Bahir Dar Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
The Wellcome Trust 215 Euston Road London NW1 2BE United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene & Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
London School of Hygiene & Tropical Medicine Keppel Street London WC1E 7HT United Kingdom
The Carter Center 453 Freedom Parkway Atlanata 30307 United States of America
The Carter Center Ethiopia Addis Ababa Ethiopia
Amhara Regional Health Bureau Bahir Dar Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Matthew Burton matthew.burton@lshtm.ac.uk +44 (0)20 79272329 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Reader in International Eye Health
Role Name Email Phone Street address
Public Enquiries Esmael Habtamu esmael.ali@lshtm.ac.uk +251 915676955
City Postal code Country Position/Affiliation
Bahir Dar Ethiopia Trial Coordinator
Role Name Email Phone Street address
Scientific Enquiries Matthew Burton matthew.burton@lshtm.ac.uk +44 (0)20 79272329 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Reader in International Eye Health
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information