In March 24, 2023, the STOP team in Ethiopia concluded the last visit of the last participant in the ALIVE trial
A total of 3,912 school children were screened and 861 were randomised and treated in the three trial sites (Ethiopia, Mozambique and Kenya) during Phase 3 of the ALIVE trial, which has now officially ended.
The ALIVE trial met its primary endpoint of treating 501 children infected with Trichuris trichiura or whipworm (the target was 499), and its secondary endpoint of treating 348 children with hookworm (the target was 312). “Unfortunately, we did not reach the target for Strongyloides stercoralis infections, but that was not our primary objective,” explains Alejandro Krolewiecki, who is leading the clinical trial.
During the trial, the children were first asked to give a stool sample that was screened for infection by the various soil-transmitted helminths (STH). If the sample was positive for one or more STH, the child was randomly assigned to receive either the standard treatment (albendazole alone) or the pill combining a fixed dose of albendazole and ivermectin, the safety of which had been previously confirmed in Phase 2 of the trial. After treatment, all the children had 5 follow-up visits and were asked to provide at the last visit (around day 21) another stool sample for analysis.
Now that the recruitment is complete, the research team is busy analysing the data and hopes to have some preliminary results ready for the next annual meeting of the consortium, which will take place in Mozambique in September 2023. The analysis will show whether the fixed dose combination is more effective than the standard treatment for treating Trichuris and hookworm.
“We are also busy preparing the reports for submission to the European Medicines Agency (EMA) in November this year so that we can register the product, which has been accepted by the medicines4all procedure,” adds Krolewiecki.