The First Phase of the EChiLiBRiST Project Clinical Trials Launches in Mopeia, Mozambique

The randomised controlled trial aims to assess the efficacy of a novel triage strategy integrating a rapid prognostic test for paediatric patients with fever.

The EChiLiBRiST Project has officially launched the initial phase of its first Clinical Trial (CT1) at the Mopeia Sede Health Centre in rural Mozambique. This randomised controlled trial will assess the efficacy of a novel risk stratification strategy that integrates a rapid biomarker-based prognostic test into the current standard of care for triaging paediatric patients with febrile illness attending outpatient departments and emergency health facilities in low- and middle-income settings. Consortium leader, ISGlobal, is sponsoring the trial which will be implemented locally by the Centro de Investigação de Saúde de Manhiça (CISM).

From Protocol to Practice: Activating the Clinical Site and Piloting the First Participants

The launch in June included comprehensive staff training, a site initiation visit, and the piloting of first participants. Training sessions were led by members of the ISGlobal team, Bàrbara Baro (PI), Andrea Alemany, and Pere Millat (Clinical Coordinators), and the CISM team, Sádia Mahumana (Clinical Coordinator for the Mozambican site) and Bento Nhancale (Project Manager). All clinical and laboratory staff who will be conducting study visits acquired the skills needed to carry out key procedures, including:

• Obtaining informed consent
• Clinical procedures
• Sampling and laboratory procedures
• Data entry for screening, baseline, and follow-up visits

A site initiation visit was also conducted to ensure the site was fully prepared for the study. Representatives from ITClinical, the clinical monitoring team, led an update on Good Clinical Practices and reviewed all trial procedures with the sponsor and the site team. They also confirmed that the investigator site file and site installations were in full compliance, ensuring the trial can be conducted ethically, safely, and in adherence to the protocol and regulations. This important milestone was marked with the presence of the Site PI, Inácio Mandomando, and the Site Study Coordinator, Anélsio Cossa.

Following this, the piloting of the first participants took place with guidance from the sponsor, allowing site staff to address any immediate questions that arose during recruitment and study visits.

Assessing the Efficacy of a Novel Risk Stratification Stratey

The primary goal of this randomised clinical trial is to assess the efficacy of a novel risk stratification strategy that integrates a rapid, point-of-care test based on the quantification of host-response biomarkers into routine triage for children with fever in low- and middle- income countries. Specifically, the study aims to evaluate how well this revolutionary approach supports health workers in appropriately determining the need for hospital admission. Its performance will be compared against the current standard of care triage, based on the Integrated Management of Childhood Illness (IMCI) guidelines, which rely solely on clinical signs and symptoms.

In Mozambique, the study will enrol children under 5 years of age presenting with fever or suspected severe infection to the Mopeia Sede Health Centre. Participants will be randomly assigned to either the control group, receiving standard care triage based on the IMCI guidelines alone, or the intervention group, where IMCI will be complemented by the rapid point-of-care prognostic test. In the intervention arm, results of the biomarker-based test will classify patients into a traffic light severity system (green, orange, or red), reflecting risk of progression to severe outcomes. This system will support the decision for further observation or admission, versus discharge home. All participants will be followed up on days 3 and 7 to assess the “appropriateness” of triage decisions, based on the occurrence of danger signs, need for reconsultation or readmission, and mortality.

The launch of CT1 represents a pivotal advancement in the EChiLiBRiST Project’s efforts to enhance evidence-based risk assessment for febrile children in low-income settings, with implementation of the trial in Lambaréné, Gabon, planned for next year.

EChiLiBRiST is a consortium of 13 institutions led by the Barcelona Institute for Global Health (ISGlobal) and funded by European Union’s Horizon Europe research and innovation programme. The project is being implemented in Mozambique by the Manhiça Health Research Centre (CISM), in Gabon by the Centre de Recherches Médicales de Lambaréné (CERMEL), and in Ethiopia by Haramaya University.