Health Trials

Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness

ConditionSoil-Transmitted Helminths
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-17
SponsorInsud Pharma

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Pre-screening Phase
  • Screenig Phase
  • Randomization
  • Baseline Effectiveness Cohort
  • Day 0 Trial Intervention
  • Active Surveillance (study visit Day 1, Day 2 and Day 7)
  • Passive Surveillance
  • Post-Treatment Effectiveness Evaluation

Treatment groups

20,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Insud Pharma

Lead sponsor

Ghana Health Services

Collaborator

Kenya Medical Research Institute

Collaborator

Bridges to Development

Collaborator

Sanger Institute

Collaborator

Barcelona Institute for Global Health

Collaborator

European Union

Collaborator

Swiss Confederation

Collaborator

Fundación Mundo Sano

Collaborator

Source ClinicalTrials.gov