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.: PACTR202402529220760 Date of Approval: 23/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title REALISE: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness
Official scientific title A Pragmatic Phase III Multi‐Centre Clinical Trial to Evaluate the Safety and Effectiveness of a Single Dose of an Albendazole-Ivermectin Coformulation vs Albendazole for Preventive Chemotherapy of Soil‐Transmitted Helminth Infections in School-Aged Children
Brief summary describing the background and objectives of the trial Background: Soil-transmitted helminths (STH) are a group of parasitic worms that cause a major cumulative disease burden worldwide. In the search for safe, efficient and logistically simple solutions to distribute and administer therapeutic alternatives for STH, our group established an international public-private partnership to design and validate innovative products and strategies for the control of STH as a public health problem. The main aim of this consortium is to evaluate a fixed-dose co-formulation (FDC) of IVM and ALB to treat all STH (including S. stercoralis). Study Description: Multi-centric, randomized by school, two-arm, parallel, open-label, pragmatic trial to evaluate the safety and effectiveness of FDC (experimental arm) against ALB (active control arm). The two study arms consist of: - Arm 1: Single dose of a tablet of FDC 400 mg/18 mg IVM or 400 mg ALB/9 mg IVM, administered according to the following age criteria: • For children from 5-14 years old (included) at the time of screening visit: 1 tablet of FDC 400 mg ALB/9 mg IVM • For children from 15-17 years old (included) at the time of screening visit: 1 tablet of FDC 400 mg ALB/18 mg IVM - Arm 2: Single dose of a tablet of ALB 400 mg (active control arm). Objectives: Primary objective - To evaluate and compare the safety of the FDC against ALB via MDA. Secondary objective - To evaluate the effectiveness of one round of MDA with FDC compared to ALB against T. trichiura. Exploratory objectives - To evaluate the effectiveness of one round of MDA with FDC compared to ALB against S. stercoralis by serology. - To evaluate the effectiveness of one round of MDA with FDC compared to ALB against hookworm. - To evaluate the effectiveness of one roun
Type of trial RCT
Acronym (If the trial has an acronym then please provide) REALISE
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Soil-transmitted helminths
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/07/2024
Actual trial start date
Anticipated date of last follow up 30/09/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 20000
Actual target sample size (number of participants)
Recruitment status Not yet 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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Albendazole 400 mg Single dose Single dose of a tablet of ALB 400 mg (active control arm). 10000 Active-Treatment of Control Group
Experimental Group FDC Albendazole and Ivermectin 400 mg/18 mg IVM or 400 mg ALB/9 mg IVM Single dose Single dose of a tablet of FDC 400 mg/18 mg IVM or 400 mg ALB/9 mg IVM, administered according to the following age criteria: • For children from 5-14 years old (included) at the time of screening visit: 1 tablet of FDC 400 mg ALB/9 mg IVM • For children from 15-17 years old (included) at the time of screening visit: 1 tablet of FDC 400 mg ALB/18 mg IVM 10000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age: 5 to 17 years old (included). - Height: over 90cm. - Parental acceptance to participate in the study by obtaining written informed consent approved by the Ethics Committee. Written assent will also be obtained from children according to the local national legislation. (In Kenya written assent will be obtained from children 12-17 years old and in Ghana for children 15-17 years old.) - Epidemiological risk of being infected by Loa loa. - Serious medical illness, per investigator’s criteria. - Any condition prevents the appropriate evaluation and follow-up of the participant, per the investigator’s criteria. - Known hypersensitivity to any component of either study treatment. - Pregnant or first week post-partum, reported by the participant during interview. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 5 Year(s) 17 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
No 01/03/2024 The Scientific and Ethics Review Unit SERU
Ethics Committee Address
Street address City Postal code Country
P.O. BOX 54840 00200 OFF MBAGATHI ROAD, NAIROBI, KENYA Nairobi 54840 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/03/2024 Ethics And Research Management Ghana
Ethics Committee Address
Street address City Postal code Country
Dodoo Lane, Behind Accra High Court Complex or Opposite Tema Station, Osu, Accra Accra - Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Frequency, type and severity of related AEs and SAEs for FDC and ALB Day 0, 1, 2, 3, 4, 5, 6, 7
Secondary Outcome Reduction in T. trichiura prevalence determined by microscopy for FDC and ALB. Baseline, day 21, month 11
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya Medical Research Institution KEMRI P.O. Box 54840 00200, Off Mbagathi Road, Nairobi, Kenya Nairobi 54840 Kenya
Ghana Health Services GHS Dodoo Lane, Behind Accra High Court Complex or Opposite Tema Station, Osu, Accra Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Anna van Saksenlaan 51 2593 HW The Hague, The Netherlands The Hague 2593 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laboratorios Liconsa SA Manuel Pombo Angulo 28, Madrid 28050, Spain Madrid 28050 Spain Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Barcelona Institute for Global Health ISGlobal Rosello 132 Barcelona 08036 Spain
Wellcome Sanger Institute WSI Hinxton, Cambridge, CB10 1SA, UK Cambridge United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Alejandro Krolewiecki alekrol@hotmail.com +5491131838673 Manuel Pombo Angulo 28, Madrid 28050, Spain
City Postal code Country Position/Affiliation
Madrid 28050 Spain Principal Investigator Laboratorios Liconsa
Role Name Email Phone Street address
Principal Investigator Benson Singa singabo2008@gmail.com 254722205901 P.O. Box 54840 00200 Off Raila Odinga Way. Nairobi, Kenya.
City Postal code Country Position/Affiliation
Nairobi 54840 Kenya Principal Investigator KEMRI
Role Name Email Phone Street address
Principal Investigator Abraham Oduro abraham.oduro@ghs.gov.gh 233302682709 Dodoo Lane, Osu, Accra
City Postal code Country Position/Affiliation
Accra Ghana Principal Investigator GHS
Role Name Email Phone Street address
Public Enquiries Celia Olmos Celia.Olmos@chemogroup.com 34917711500 Laboratorios Liconsa SA, Manuel Pombo Angulo 28, Madrid 28050, Spain
City Postal code Country Position/Affiliation
Madrid 28050 Spain Project Manager Laboratorios Liconsa
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share anonymized Individual Participant Data upon request through the Infectious Diseases Data Observatory (IDDO). IDDO is a scientifically independent, multi-disciplinary coalition of the global infectious disease and emerging infections communities. It provides the methods, governance and infrastructure to translate data into evidence that improves outcomes for patients worldwide. Statistical Analysis Plan,Study Protocol - -
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