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.: PACTR202401655267670 Date of Approval: 15/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluating the effectiveness of one oral dose versus two oral doses of ivermectin in mass drug administration against scabies and tungiasis in Gamo zone, Southwest Ethiopia: a cluster randomized controlled trial
Official scientific title Evaluating the effectiveness of one oral dose versus two oral doses of ivermectin in mass drug administration against scabies and tungiasis in Gamo zone, Southwest Ethiopia: a cluster randomized controlled trial
Brief summary describing the background and objectives of the trial Scabies and tungiasis are the most neglected tropical skin diseases causing significant health problems. Few studies show that topical ivermectin significantly reduces the number of lesions caused by tungiais, whereas scabies can be successfully controlled by two oral doses of ivermectin-based treatment. However, the current two oral doses regimen presents a number of barriers to programmatic implementation of mass drug administration (MDA). There are limited studies evaluating the effectiveness of one versus two oral doses of ivermectin in reducing scabies and tungiasis. The findings from previous studies were inconsistent and most of them were not purely randomized control trial. Besides there is no study conducted in non-island areas including Ethiopia. The current study aims to evaluate whether the MDA with a single oral dose of ivermectin is non-inferior to two oral doses of ivermectin in reducing scabies and tungiasis in the study area. A two arm cluster-randomized, non-inferiority trial will be conducted to compare one dose versus two doses of ivermectin-based MDA. A total of 32 clusters comprising 3782 individuals will be randomized into two arms in a 1:1ratio. One arm will receive one dose of ivermectin, and another arm will receive two doses of ivermectin. Randomization will be done at the cluster level.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 25/11/2023
Actual trial start date 25/11/2023
Anticipated date of last follow up 25/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 3782
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Two doses of ivermectin based MDA 12 months Ivermectin is an antiparasitic drug in the avermectin class that is active against the scabies mite. It is currently the only oral therapy available for scabies in Ethiopia and allows greater compliance than with topical therapy. Oral therapy can be directly observed, which ensuring treatment adherence. In this study, all participants will be offered 3 mg oral ivermectin scored tablets. As weight scales are generally unsuitable for implementation of MDA, we will use dosing strategies based on age . The second dose will be given between 7 and 14 days for those taking two oral doses of ivermectin according to the national guidelines of Ethiopia. Age 2 year to 6: 1 tab of 3 mg Oral ivermectin Age 7 to 12: 2 tabs Oral ivermectin Age 13 to 18: 3 tabs Oral ivermectin Age 18 and above: 4 tablets of oral ivermectine 1891 Active-Treatment of Control Group
Experimental Group one dose of oral ivermectin MDA 12 months All participants in this arm will be offered 3 mg oral ivermectin scored tablets at the same dosage as the two-dose oral ivermectin group. However, unlike the two-dose arm, they will not repeat the dosage within a 7 to 14-day period. 1891
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All participants who are older than two years in the selected clusters are eligible to participate in the study. Those individuals with an allergy to Ivermectin, treatment within the last 7 days with Ivermectin, pregnant women, breastfeeding women, and participants who decline treatment will be excluded. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 2 Year(s) 80 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 20/03/2023 Institutional Review Board of Arba Minch University
Ethics Committee Address
Street address City Postal code Country
Arba Minch, Ethiopia Arba Minch 21 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The prevalence of scabies 3, 6 and 12 months
Secondary Outcome  The prevalence of tungiaisis  The prevalence of impetigo  The proportion of adverse events associated with oral ivermectin MDA within 14 days of intervention 3, 6, 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mazo Doyisa Health Center Gina, Gacho Baba District , Ethiopia Gina Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Arba Minch University Arba Minch, Ethiopia Arba Minch 21 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Arba Minch University Arba Minch, Ethiopia Arba Minch 21 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
South Nation Nationalities and Peoples Regional Health Bureau Hawassa, Ethiopia Hawassa 149 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alemayehu Kassahun alemayehu.bekele@amu.edu.et +251913465324 Arba Minch, Ethiopia
City Postal code Country Position/Affiliation
Arba Minch 2067 Ethiopia Associate Researcher
Role Name Email Phone Street address
Scientific Enquiries Fekadu Fekadu Massebo fekadu.massebo@amu.edu.et +251911733885 Arba Minch, Ethiopia
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Associate professor Public Health Entomologist at Arba Minch University
Role Name Email Phone Street address
Scientific Enquiries Wendemagegn Enbiale wendemagegnenbiale@gmail.com +251911034612 Bahir Dar, Ethiopia
City Postal code Country Position/Affiliation
Bahir Dar Ethiopia Professor of Dermatovenerology at Bahir Dar University
Role Name Email Phone Street address
Scientific Enquiries Daniel Woldeyes dannybiomed@yahoo.com +251913188950 Arba Minch, Ethiopia
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Assistant Professor of Biomedical Sciences at Arba Minch University
Role Name Email Phone Street address
Public Enquiries Tsegaye Yohanes tsegaye.yohanes@yahoo.com +251910083945 Arba Minch, Ethiopia
City Postal code Country Position/Affiliation
Arba Minch 21 Ethiopia Director for the Collaborative Research and Training Center for Neglected Tropical Diseases of Arba Minch University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes After de-identification, all individual participant data acquired during the course of the study will be provided. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be made available soon after publication Anyone who has access to the data can utilize it for any purpose, and the information will remain available indefinitely. We provide a link for easy access.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information