This randomised, double-blind trial will test whether L-Citrulline supplementation improves short and long-term outcomes of children presenting with fever.
Last week, the Clinical Trial 2 (CT2) of the EChiLiBRiST project officially commenced at the site in Maputo, Mozambique. The trial is being conducted at the Hospital Central de Maputo (HCM), where the study and recruitment is being led by the Faculty of Medicine of the Universidade Eduardo Mondlane (UEM) with the support Centro de Investigação de Saúde de Manhiça (CISM). Consortium leader ISGlobal is acting as sponsor for the trial.
The randomised, double-blind trial aims to demonstrate that a simple nutritional intervention, L-Citrulline oral supplementation, can improve health outcomes and survival in hospital admitted paediatric patients with fevers or severe disease showing high blood biomarkers’ levels. CT2 runs in parallel with the CT1 of the EChiLiBRiST project, which assesses a novel risk-stratification strategy based on biomarkers’ assessment for children with fever who attend the outpatients’ facilities.
The Green Light for CT2 Launch
The launch of the trial included a site initiation visit and the beginning of the recruitment for the clinical trial. The site initiation visit was conducted by representatives of the clinical monitoring team, ITClinical, who reviewed the site facilities and documentation, and confirmed that everything was in full compliance with the protocol and the Good Clinical Practices. A visit of the hospital, university, and study pharmacy took place to ensure that all site installations are fully prepared and suited to the needs of the trial. Following the visit, the go ahead was given for starting participants’ recruitment, confirming that the site was well-prepared and in-line with all safety and ethical guidelines.
A Promising First Phase of Recruitment
Patients aged 1 to 59 months old admitted to Hospital Central de Maputo with fever or potentially severe disease are eligible for recruitment. Following recruitment, patients’ blood biomarkers (sTREM-1) levels are measured. Participants with moderate to high levels of biomarkers are randomised into either the treatment group, receiving oral L-citrulline, or the control group, who are administered an indistinguishable placebo. Follow-up visits are conducted for all randomised participants on day 3, 7 and 28, to assess the effectiveness and safety of the intervention. A final visit 6 months after recruitment will examine long-term outcomes.
In a strong start to the trial, patient recruitment in Maputo reached 6 enrolments in just 3 days after the official opening on Monday 8th December. The team at HCM-UEM successfully navigated initial challenges, and have been able to gather high-quality data. After the recruitment of the first participants, they have refined their workflow to seamlessly integrate trial procedures into routine clinical care for admitted patients, while ensuring clear and effective communication with caregivers throughout all study activities.
The launch of CT2 presents an excellent opportunity to share lessons learnt from the implementation in Maputo with the team at Haramaya University, aiming for an equally successful clinical trial launch at the Hiwot Fana Specialized University Hospital in Harar, Ethiopia, early next year. The achievement of this milestone in the EChiLiBRiST project reflects the dedication and perseverance of all partners, working determinedly towards the project’s goal of improving health outcomes for children with infections in low-income countries and, ultimately, the reduction of child mortality.
This project has received funding from the European Union’s Horizon Europe research and innovation programme under grant agreement No 101057114.
Disclaimer: This reflects only the authors’ view and the European Commission is not responsible for any use that may be made of the information it contains.
