INTEGRATE

INTEGRATE is an international consortium of 15 leading research institutes, health facilities and humanitarian organizations from 10 countries working together to fight Lassa fever.

Coordinated by the medical humanitarian NGO, ALIMA and the CORAL (Clinical and Operational Research Alliance) platform, in collaboration with the Bernhard Nocht Institute for Tropical Medicine (BNITM) and the world’s largest Lassa fever treatment centers – the Irrua Specialist Teaching Hospital (ISTH) and the Federal Medical Center Owo (FMCO) in Nigeria, this pioneering five-year study brings together research structures from West Africa, Europe and the USA. 

The aims of this consortium are to set up a clinical trial platform in West Africa to identify new and more effective drugs to treat Lassa fever, build capacity for sustainable clinical research in West Africa and raise awareness about Lassa fever within local communities.

Lassa fever adjunct treatment with dexamethasone - the LADEX trial

This is an open label randomized controlled phase II clinical trial to assess the safety and tolerability of adjunct dexamethasone in addition to standard of care antiviral therapy compared to standard of care antiviral therapy alone for the treatment of moderate to severe Lassa fever cases. The trial is conducted in collaboration with the Irrua Specialist Teaching Hospital in Edo State, Nigeria.

Capacity building for rapid containment of Lassa fever outbreaks and development of medical countermeasures in Nigeria - Capacity building for the realisation of clinical trials

To rapidly contain Lassa fever outbreaks and develop medical countermeasures for Lassa fever disease in Nigeria, it is necessary to review existing therapeutic options (ribavirin) due to doubt about the therapeutic efficacy and to investigate new drug candidates (e.g. favipiravir) for clinical use in Lassa fever patients. Together with the Irrua Specialist Teaching Hospital (ISTH) in Nigeria, capacities are built and clinical studies are conducted jointly to establish local expertise:

• PAIRR: A prospective observational study to evaluate pharmacokinetic properties of routine ribavirin treatment for Lassa fever patients at ISTH. 
• SAFARI: A randomized, controlled phase II trial to investigate the pharmacokinetics, tolerability and safety of the drug candidate favipiravir by itself and in combination with ribavirin for the treatment of Lassa fever at the ISTH and theFederal Medical Center Owo (FMCO) in Nigeria. The SAFARI project is carried out in collaboration with the Institute National de la Santé et de la Recherche Médicale (Inserm), the Université Bordeaux,  the Alliance for International Medical Action (ALIMA), all France, and the Institute of Pharmacy at the University of Hamburg, Germany.

The capacity building activities of the Lassa-Nigeria project are funded by the Global Health Protection Programme (GHPP) of the German Federal Ministry of Health.