L-citrulline to reduce complications in hospitalized young children with fever
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
This trial will test whether giving L-citrulline versus placebo to hospitalized children aged 1 month to under 5 years who have a moderate-to-high bedside sTREM-1 risk result can reduce death and serious complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2200 (estimated) |
| Ages | 0 Months to 60 Months |
| Sex | All |
| Sponsor | Barcelona Institute for Global Health Academic / other |
| Locations | 2 sites (Harar and 1 other locations) |
| Trial ID | NCT06426147 on ClinicalTrials.gov |
What this trial studies
Children admitted with fever or suspected severe infection are first screened at the bedside with a rapid sTREM-1 point-of-care test to assign low, moderate, or high risk. Those aged 1 month to under 5 years with a moderate (yellow) or high (red) sTREM-1 result are randomly assigned 1:1 to receive L-citrulline or placebo in addition to standard care. Participants are followed during admission and by visits or phone at day 3, 5, 7, day 28 and month 6 to capture outcomes. The primary outcome is a composite adverse disease outcome within 28 days including death, new neurological problems, major kidney events, need for organ support, shock, coma, severe respiratory distress or readmission.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 month to under 5 years who are admitted with fever or suspected severe infection and whose bedside sTREM-1 result indicates moderate or high risk.
Not a fit: Children outside the age range, those classified as low risk by the sTREM-1 test, admitted for non-medical/social reasons, or with known contraindications to the supplement are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, L-citrulline could lower in-hospital deaths and serious complications for high-risk febrile children identified by the bedside sTREM-1 test.
How similar studies have performed: Bedside sTREM-1 measurements have prior supportive evidence as a prognostic marker, but using L-citrulline as an adjunctive treatment in this pediatric inpatient setting is novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Harar and 1 other locations
- Hararghe Health Research — Harar, Ethiopia (Recruiting)
- Hospital Central de Maputo — Maputo, Mozambique (Recruiting)
Study contacts
- Principal investigator: Quique Bassat, Prof — Barcelona Institute for Global Health
- Study coordinator: Quique Bassat, Prof
- Email: quique.bassat@isglobal.org
- Phone: 93 227 92 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.