We are pleased to share an update from our ongoing EMPIRICAL trial. EMPIRICAL is an acronym for “Empirical treatment against cytomegalovirus and tuberculosis in severe pneumonia in HIV-infected infants: a randomized controlled clinical trial”. It is a research project funded by the European and Developing Countries Clinical Trial Partnership (EDCTP) that 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.
The 4th annual meeting was held in Uganda between November 15th-16th, 2022 with the participation of Executive Committee representatives, the independent members of the Trial Steering Committee and local stakeholders.
During the meeting, the Chief Investigator, Dr. Pablo Rojo, announced the positive assessment of the external Data and Safety Monitoring Board (DSMB). The DSMB reviewed the 4th 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 the Trial Steering Committee Chair, Prof. Philippa Musoke and provided a space for stakeholders to discuss the importance of our project with researchers with multidisciplinary profiles including medical doctors, laboratory staff and nurses among others. We had the pleasure to receive the delegation from the Uganda National Policy for HIV Advanced disease and present the EMPIRICAL project.
EMPIRICAL is a key infrastructure for the implementation of clinical trials in hospitalized children in Sub-Saharan Africa. EMPIRICAL allows us to leverage translation research and increase research opportunities, bringing together resources to translate EMPIRICAL results into benefits for patients.