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 groupSponsors and collaborators
Source ClinicalTrials.gov