L-citrulline to reduce complications in hospitalized young children with fever

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.