Successful Conduct of the SAFARI Clinical Trial
Following the refurbishment of the sites, the training of the study teams and the successful conduct of the PAIRR clinical trial (which was recently published), the SAFARI clinical trial was conducted at two Nigerian sites from 30 July 2021 to 17 November 2022. 40 participants were recruited and followed up until completion of the treatment.
Recently, in July this year, the results of the clinical study PAIRR have been published. This publication resulted from the fruitful collaboration between ISTH and BNITM, which materialized in capacity building activities and the conduct of this observational clinical study.
Following the above-mentioned clinical study, a clinical trial comparing the pharmacokinetics, tolerability, and safety of the Lassa standard treatment in Nigeria, Ribavirin, to a potential efficacious new treatment called Favipiravir was conducted, after obtaining the regulatory and ethical approvals at national and local levels in the country. Two study sites were involved: in addition to the Irrua Specialist Teaching Hospital (ISTH) in Edo State, the Federal Medical Center in Owo (FMCO)in Ondo State recruited, managed and followed-up study participants. At each site, 20 participants were enrolled, 10 being randomized into each of the 2 arms and a total number of 40 patients were recruited. The last patient visit took place on 17 November 2022, the analysis of pharmacokinetics and statistical analysis are now being performed.
Fakten
In addition, capacity building activities were continued. The clinicians involved in the project were invited to Hamburg to participate in different trainings and courses, including, but not limited to, epidemiology and control of infectious diseases, autopsy and Minimally Invasive Tissue Sampling (MITS), and ultrasound trainings.
Date: December 2022
