The trial site in Mozambique has reached the required number of participants infected by Trichuris trichiura

ALIVE trial in Mozambique

The overall goal of the STOP project is to find a more effective treatment for all types of intestinal worms (called soil-transmitted helminths or STH). However, there is one worm species that is of particular interest to STOP researchers: Trichuris trichiura (commonly known as whipworm).

“Trichuris is particularly resistant to albendazole, which is the current treatment recommended by the WHO,” explains Jose Muñoz, ISGlobal researcher and principal investigator of the STOP project. By adding ivermectin to albendazole and combining the two drugs in a single pill, the STOP team hopes to increase efficacy against all worms, especially whipworm.

Thus, the primary endpoint (main goal) of the trial is to evaluate the efficacy of this new pill against Trichuris. But to do so, they need to recruit a large enough sample of children infected with this worm. This milestone has just been reached in Mozambique.

An important milestone 

The Mozambican team, composed by CISM researchers, started recruiting participants in October of last year. They screened 1,200 schoolchildren from the Escola Primaria Completa de Pateque, in Maluana, southern Mozambique; 161 of them tested positive for Trichuris and were randomised to treatment (they received albendazole alone or the albendazole-ivermectin combination). “With these 161 children, together with those recruited in Kenya, we reached the sample size needed for Trichuris, which was 499,” says Augusto Messa Jr., PhD student at CISM and part of the STOP team.

“This is a very important milestone. We can now assess the new treatment’s efficacy against Trichuris, which is the trial’s primary endpoint,” explains Inácio Mandomando, trial site principal investigator.

Recruitment at the three sites (Kenya, Mozambique, Ethiopia) has ended, and the STOP team will now start analysing the final results.

The ALIVE trial recruited children from the Pateque school in Southern Mozambique