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Tests treatment safety and results for Soil-Transmitted Helminths
Official title Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness
ClinicalTrials.gov ID: NCT06282315
What this study is testing
What is Pre-screening Phase?
Pre-screening Phase is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for soil-transmitted helminths.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 17. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- Epidemiological risk of being infected by Loa loa, defined as those who have visited any of the following countries: Angola, Cameroon, Central Africa...
- Serious medical illness, defined as participants showing symptoms of acute illness which could hamper the participation in the trial, such as...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Accra, Accra, Ghana
- Nairobi, Nairobi County, Kenya
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 17 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Accra, Accra, Ghana; Nairobi, Nairobi County, Kenya. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.