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
This trial does not accept healthy volunteersQualifiers
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 population
Pediatric patients (weight ≥10kg and age ≤22 years) with acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy (RRT), per device Instructions For Use. All patients who receive treatment with QUELIMMUNE as part of their therapy are included in this registry.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
QUELIMMUNE (SCD-PED)
DeviceQUELIMMUNE device used as part of clinical practice.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: QUELIMMUNE Surveillance Registry Participants1 intervention
Trial outcomes
Primary outcomes
1
Safety
New (secondary) bloodstream infections within 28 days from the time of QUELIMMUNE initiation or through hospital discharge, whichever is sooner
Time frame
28 days or through hospital discharge, whichever is soonerSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov