L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients)

Launched by BARCELONA INSTITUTE FOR GLOBAL HEALTH · May 17, 2024

Keywords

ClinConnect Summary

Children admitted to hospital and meeting the study eligibility criteria who are 0-\<60 months of age will be eligible for study inclusion, and for initial biomarker screening using the study-designed rapid triaging PoC test, based on the measurement of sTREM-1. Study participants aged 1m-\<5 years of age with sTREM-1 values classified as moderate (i.e., "yellow") or high-risk (i.e., "red") in the traffic light risk-stratification system will be randomly allocated (1:1) to receive L-Cit intervention or placebo. All study participants will be followed for 6 months, with study visits at the s...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Enrolled in the initial prognostic screening component.
• • Sick children with fever (axillary temperature\>37.5ºC) or a history of fever (within the preceding 72h) or with suspected severe disease.
• • 1m-\<60 months of age.
• • With an indication for admission, or having already been admitted to hospital due to their illness.
• • With an sTREM-1 PoC result classifying their disease as of "moderate-high risk" ("yellow" or "red") upon study recruitment and within D3.
• • Residents in the study area or willing to be contacted and traced during the study duration.
• • Willing to sign an informed consent document.
• • Willing to undergo and adhere to study procedures as explained in the IC document.
• Exclusion Criteria:
• • Admission to hospital for social reasons (and not on account of their disease).
• • Children for which informed consent document has not been signed.
• • Known allergy or contraindication to any of the study supplements including lactose intolerance or observing a lactose-free diet.
• • Concurrent participation in any other clinical trial.
• • Patient under NPO or "nothing by mouth" prescription .
• • Contraindication for the insertion of a nasogastric tube (NGT) of for the enteral administration of drugs through the NGT in children who cannot tolerate by mouth.
• • Critically sick patient whose prognosis is considered by the clinical researcher as fatal outcome in the following hours after screening.
• • Any other condition determined by the investigators that makes it unlikely that the participant would complete the follow up until day 28 of study.

Trial Officials