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Essai clinique

QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

NCT : NCT06517810 · RECRUITING

ID NCTNCT06517810
StatutRECRUITING
Date de début2024-07-19
SponsorSeaStar Medical (INDUSTRY)
First posted
Last updated

Résumé succinct

QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT. The purpose of this surveillance registry is to prospectively collect safety data among all patients treated with QUELIMMUNE under the HDE. More specifically, we intend on comparing the incidence of new (secondary) blood stream infections in the first 28 days after SCD-PED initiation to a comparator group of matched CKRT patients with sepsis who did not receive treatment with QUELIMMUNE

Source officielle

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