Multiple Organ Dysfunction Syndrome clinical trials at UCSF

3 in progress, 2 open to eligible people

When several body organs don't work properly, it's called multiple organ dysfunction syndrome. UCSF is running trials with a medicine named GM-CSF for kids with this. Another trial is using a drug called anakinra.

Showing trials for

  • GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS

    open to eligible people ages up to 17 years

    The GRACE-2 study is a prospective, multi-center, double-blind, randomized controlled trial of the drug GM-CSF vs placebo in children with sepsis-induced multiple organ dysfunction syndrome (MODS) who have immunoparalysis with mild to moderate inflammation.

    Oakland, California and other locations

  • Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

    open to eligible people ages up to 17 years

    The TRIPS study is a prospective, multi-center, double-blind, adaptively randomized, placebo-controlled clinical trial of the drug anakinra for reversal of moderate to severe hyperinflammation in children with sepsis-induced multiple organ dysfunction syndrome (MODS).

    Oakland, California and other locations

  • GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study

    Sorry, in progress, not accepting new patients

    This study is an open-label, multi-center, interventional trial in which children with sepsis-induced MODS undergo surveillance immune function testing beginning on Day 2 of MODS. Those children who demonstrate immunoparalysis (TNF-alpha response <200 pg/ml) will receive a 7-day course of GM-CSF at a dose of 125 or 250 mcg/m2/day by either the intravenous (IV) or subcutaneous (SQ) route. The goal of the study is to establish the dose and route of delivery that results in resolution of immunoparalysis (TNF-alpha response >=200 pg/ml) by the morning after the 3rd scheduled dose with persistent resolution of immunoparalysis on the morning after the 7th scheduled dose. Resolution of immunoparalysis in 8 out of the first 10 subjects in a study treatment arm represents a successful dose and route. The goal of this study will be achieved through the following Specific Aims: Specific Aim 1. Establish the immunologic efficacy of GM-CSF administered by the IV and SQ routes in children with immunoparalysis in the setting of sepsis-induced MODS. Specific Aim 2. Estimate the pharmacokinetic parameters by the IV and SQ GM-CSF administered in pediatric sepsis-induced MODS. Specific Aim 3. Demonstrate the feasibility of screening, enrollment, drug delivery, and sample collection for a multi-center immunostimulation trial in children with sepsis-induced MODS.

    San Francisco, California and other locations

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