The first phase of the ALIVE trial will take place in Kenya, with the aim of evaluating the safety of the fixed dose combination
Children from the Jomo Kenyatta school receive an envelope with the treatment (photo: Myriam Solé)
The first participants of the clinical trial conducted by the STOP consortium have been recruited in Kwale County, Kenya. This first phase of the trial (phase 2) will test the safety of a fixed dose combination of ivermectin and albendazole for the treatment of soil-transmitted helminths in children.
After almost three years of careful preparation, members of the STOP consortium met in Kenya earlier this month to launch the ALIVE clinical trial, which represents the main pillar of the project. Before starting the recruitment of participants, KEMRI and ISGlobal researchers visited the trial site to train the local team, check that everything was ready from the regulatory and logistical point of view and explain the project to the parents of the school children that will be participating in the trial . After that, the real trial activities started, under close supervision of Stella Kepha (trial site coordinator) and Charles Mwandawiro (trial site PI). Children were screened for the presence of whipworm (Trichuris trichiura) eggs in their faeces. If they were infected, they were randomly assigned to the experimental groups (fixed dose combination of albendazole and ivermectin) or the control group (albendazole alone). The children will be closely monitored for any safety issues and their faeces will be analysed 21 days after treatment to evaluate treatment response.
“The activities that are underway in Kwale these days are a landmark for our Consortium; the data this trial generates is key in the search of better alternatives for the treatment of soil-transmitted helminths. This is a collective work that involved a long and dedicated preparation”, says Alejandro Krolewiecki, who is leading the clinical trial.
This first phase of the trial plans to recruit 126 children and its main goal is to confirm the safety of the fixed dose combination in children weighing 15 kilograms or more. The next phase of the trial will recruit an additional 1100 children from the three trial sites (in Kenya, Ethiopia and Mozambique), and will analyse the efficacy of the fixed dose combination in treating infections by different soil-transmitted helminths, in addition to continue monitoring its safety.