Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness
- Summary
- An open-label, randomized by school, two-arm pragmatic trial, will be conducted involving two study sites in Sub-Saharan-Africa (SSA), Ghana and Kenya, to evaluate safety and effectiveness of the newly developed fixed dose combination (FDC) of albendazole (ALB) and ivermectin (IVM) as a single dose to treat Soil-Transmitted Helminths (STH), compared to the standard dose ALB single dose for the treatment and control of STH (REALISE study: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness). The general objectives are to validate the benefits of FDC through this pragmatic trial in a context of mass drug administration (MDA) programme to evaluate the safety as a primary endpoint and effectiveness profile as a secondary endpoint, in a large population of school-aged children.
- Short title
- Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness
- Official title
- A Pragmatic Phase III Multicentre 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-02-01
- First posted
- 2024-02-28
- Registry last updated
- 2025-09-15
- Primary completion date
- 2026-04-01
- Start date
- 2025-09-01
- Participants
- 20,000
- Participant count basis
- Estimated
- Planned participants
- 20,000
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Insud Pharma
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06282315
- ClinicalTrials.gov ID
- NCT06282315
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Single masking
- Masking description
- This is an open study. Participants and the study investigators assessing drug safety will not be blinded to treatment arms. Only the laboratory-based effectiveness measurement will be performed by blinded operators.
- Masked roles
- Outcome assessors
AEs and SAEs record of participants treated with FDC compared to ALB.
Timeframe: 7 days, active surveillance (Day 0 (1 hour), Day 1, Day 2 and Day 7 post-intervention) and passive surveillance (From Day 0 up to Day 6 post-intervention)
Adverse events will be recorded in the source documents and the electronic Case Report Form during the trial. The nature of the AE, its date and time of onset, duration and severity, therapy employed (only for SAEs) and the investigator's opinion of causality to the study drug with an alternate aetiology, if appropriate, will be documented. Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at each level of intensity. Classification of the AEs and SAEs according to their frequency will be performed by the Sponsor at the end of the trial.
Reduction in T. trichiura prevalence in participants treated with FDC compared with ALB.
Timeframe: Baseline, 21 days and 11 months post-intervention
At each time point, one stool sample will be requested from each selected participant, and the presence and number of STH eggs will be determined by a single Kato Katz method (WHO gold standard for STH diagnosis) using microscopy. T. trichiura prevalence will be considered as the number of participants infected divided by the total number of participants in the effectiveness cohort. STH diagnosis by Kato-Katz on fresh stool (samples analysed up to a maximum of 24 hours after sample collection). The stool sample will be analysed in the local laboratory to estimate STH prevalence at baseline in each school as part of evaluating the STH effectiveness of the treatment arms.
- Sex
- All
- Age groups
- Children
- Minimum age
- 5 Years
- Maximum age
- 17 Years
- Healthy volunteers
- Yes
Individuals of both sexes that attend the selected schools in the trial areas in Ghana and Kenya that meet the following criteria:
- Age: 5 to 17 years old (included).
- Height: over 110 cm.
- 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 (12-17 years old).
- Epidemiological risk of being infected by Loa loa, defined as those who have visited any of the following countries: Angola, Cameroon, Central Africa Republic, Chad, Congo, Democratic Republic of the Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan.
- Serious medical illness, defined as participants showing symptoms of acute illness which could hamper the participation in the trial, such as high-grade fever, severe diarrhoea, neurological symptoms or others, 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: female participants who are post-menarche must have a negative urine pregnancy test at screening.
- Ghana Health Service (GHS)Accra, GhanaRecruiting
- Kenya Medical Research Institution (KEMRI)Nairobi, KenyaRecruiting
- Related resource (stop2030.org)
Related records
Drugs (3)
Collaborators (8)
- Barcelona Institute for Global Health
- Bridges to Development
- European Union
- Fundacion Mundo Sano
- Ghana Health Services
- Kenya Medical Research Institute
- Sanger Institute
- Swiss Confederation