18 September 2019

We have launched the Phase III clinical trial

With the Phase III clinical trial protocol locally approved, the trial has started.

This trial seeks to evaluate the safety and efficacy of pediatric praziquantel in Schistosoma-infected children of 3 months to 6 years of age in Côte d’Ivoire and Kenya. The trial is a crucial part of the development program for the new child-friendly praziquantel orally dispersible tablet formulation. The trial designed by the Consortium’s clinical sub team, will be managed by the Medicine Department at the Swiss Tropical and Public Health Institute (Swiss TPH) and supervised by the Pediatric Praziquantel Consortium project team, led by Merck.

Investigators and teams responsible for the implementation of the Phase III trial are provided by the Université Félix Houphouët-Boigny (UFHB) in Côte d’Ivoire and the Kenya Medical Research Institute (KEMRI) – both partners of the Consortium

To prepare for the Phase III trial, all parties met in Côte D’Ivoire for an investigator meeting in January 2019, to allow exchange between partners and harmonisation of procedures for the trial. This meeting addressed scientific and operational aspects and favoured important informal exchanges between French and English-speaking team members for the benefit of the trial.

In April 2019, extensive training sessions on trial procedures were held in Kenya and Côte D’Ivoire for the local staff; these sessions also served to address any outstanding queries and to allow prompt initiation of the trial upon receipt of the green light from the authorities.

To allow the initiation of the Phase III trial, a series of challenges have been faced1 and overcome thanks to the effort of the whole team. We are proud that we have now included the first S. mansoni and S. haematobium infected children in this pivotal Phase III trial.  This study is required as another step forward towards the envisaged registration and provision of access to a suitable pediatric praziquantel formulation for treating schistosomiasis in preschool-age children.

 

1 N’Goran, E., David Aka, N.A., Ouattara, M., Huber, E., Bezuidenhout, D., Kourany-Lefoll, E., 2019. Challenges and Lessons From Conducting A Paediatric Clinical Trial in Sub-Saharan Africa: The Case of the Praziquantel Oral Dispersible Tablets Phase II Study in Côte d’Ivoire, in: Advances in Parasitology. Elsevier, pp. 75–89. https://doi.org/10.1016/bs.apar.2018.09.002