QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 22
SponsorSeaStar Medical

About this trial

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

Eligibility criteria

Qualifiers

All patients initiated on QUELIMMUNE therapy under the HDE-approved indication

Disqualifiers

Weight <10kg

Age >22 years

Known allergy to any components of QUELIMMUNE

Trial design

Treatments tested in this trial

  • QUELIMMUNE (SCD-PED)

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators