//EMPIRICAL Annual Meeting in Uganda, 15-16 November 2022

EMPIRICAL Annual Meeting in Uganda, 15-16 November 2022

The EMPIRICAL consortium held its fourth annual meeting in Uganda on 15-16 November 2022 with the participation of the Executive Committee representatives, the independent members of the Trial Steering Committee, local stakeholders and (virtual) EDCTP participation. The project aims to develop a clinical trial to evaluate whether empirical treatment against cytomegalovirus and tuberculosis improves survival of HIV-infected infants with severe pneumonia, which remains the main cause of death in this vulnerable population.

During the meeting, the Coordinator, Dr Pablo Rojo, announced the positive assessment of the external Data and Safety Monitoring Board (DSMB). The DSMB reviewed the fourth safety report and the interim analysis from the EMPIRICAL study with available data of 312 recruited children. No safety issues were identified. Therefore, the DSMB recommended that the study continues without modification.

The meeting was led by Prof. Philippa Musoke, the Trial Steering Committee Chair, and provided a space for stakeholders to discuss the importance of the study with researchers with multidisciplinary profiles including medical doctors, laboratory staff and nurses among others. A delegation from the Uganda National Policy for HIV Advanced disease were part in this meeting.

EMPIRICAL constitutes a key infrastructure model for the implementation of clinical trials in hospitalized children in Sub-Saharan Africa. It is expected that the study allows to leverage translation research and increase research opportunities, bringing together resources to translate its results into benefits for patients.