Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426147
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-10
Brief Title:
L-citrulline to Improve Adverse Outcomes in Admitted Children EChiLiBRiST Clinical Trial 2 Inpatients
Sponsor:
Barcelona Institute for Global Health
Organization:
Barcelona Institute for Global Health
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Trial of L-Citrulline Oral Supplementation to Improve Short and Long-term Outcomes of Admitted Febrile Paediatric Patients With Biomarker-determined High-risk of Adverse Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In low and middle-income countries children admitted to hospital are not similarly ill and do not all have a comparable prognosis In fact understanding at first encounter their risk of developing adverse outcomes including mortality could allow a more focused management and the tailoring of specific interventions to decrease in hospital mortality and post discharge adverse longer-term outcomes This clinical trial part of the EChiLiBRiST larger project Development and validation of a quantitative point-of-care test for the measurement of severity biomarkers to improve risk stratification of fever syndromes and enhance child survival has the two-fold objective of
1 Assessing whether a POINT-OF-CARE rapid triaging test PoC RTT based on the quantitative measurement at the bedside of the prognostic biomarker sTREM-1 soluble-triggering receptor expressed on myeloid cells 1 can reliably identify those admitted children with a higher risk of adverse outcomes and
2 Assessing whether the therapeutic intervention the L-arginine precursor L-Citrulline key in the nitric oxide biosynthesis administered orally for 28 days to those children aged 1-60 months identified as moderate-to-high risk by the prognostic biomarker can improve outcomes as compared to those receiving an indistinguishable placebo
This second objective will be assessed in a prospective multi-country multi-site individually randomised two-arm placebo-controlled double blind clinical trial involving 888 children 1-60m of age admitted to hospital and determined to be at high risk of adverse outcomes by their baseline sTREM-1 levels The trial will compare the efficacy of a twice-daily dose of L-citrulline syrup vs placebo 200-300mgkgday depending on weight-band for 28 days in reducing adverse outcomes in children with severe disease The trial will be running independently but in parallel in two high-mortality settings in Mozambique and in Ethiopia
1 Assessing whether a POINT-OF-CARE rapid triaging test PoC RTT based on the quantitative measurement at the bedside of the prognostic biomarker sTREM-1 soluble-triggering receptor expressed on myeloid cells 1 can reliably identify those admitted children with a higher risk of adverse outcomes and
2 Assessing whether the therapeutic intervention the L-arginine precursor L-Citrulline key in the nitric oxide biosynthesis administered orally for 28 days to those children aged 1-60 months identified as moderate-to-high risk by the prognostic biomarker can improve outcomes as compared to those receiving an indistinguishable placebo
This second objective will be assessed in a prospective multi-country multi-site individually randomised two-arm placebo-controlled double blind clinical trial involving 888 children 1-60m of age admitted to hospital and determined to be at high risk of adverse outcomes by their baseline sTREM-1 levels The trial will compare the efficacy of a twice-daily dose of L-citrulline syrup vs placebo 200-300mgkgday depending on weight-band for 28 days in reducing adverse outcomes in children with severe disease The trial will be running independently but in parallel in two high-mortality settings in Mozambique and in Ethiopia
Detailed Description:
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 ie yellow or high-risk ie red in the traffic light risk-stratification system will be randomly allocated 11 to receive L-Cit intervention or placebo All study participants will be followed for 6 months with study visits at the study hospitals or at home or via phone communication after discharge at day 3 day 5 day 7 day 28 and month 6 The study primary outcome will be adverse disease outcome defined as a composite of mortality incident neurological sequelae major adverse kidney event at discharge need for organ support clinical shock coma severe respiratory distress or need for readmission within 28 days after recruitment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None