Actively Recruiting
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
Led by SeaStar Medical · Updated on 2026-05-14
50
Participants Needed
15
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients initiated on QUELIMMUNE therapy under the HDE-approved indication
You will not qualify if you...
- Weight less than 10 kg
- Age greater than 22 years
- Known allergy to any components of QUELIMMUNE
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Children's of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
3
UCSF Benioff Children's
San Francisco, California, United States, 94618
Actively Recruiting
4
HealthONE HCA Rocky Mountain Children's Hospital
Denver, Colorado, United States, 80205
Actively Recruiting
5
Children's Hospital of Atlanta - Arthur M. Blank
Atlanta, Georgia, United States, 30329
Actively Recruiting
6
Children's Hospital of Atlanta - Scottish Rite
Atlanta, Georgia, United States, 30342
Actively Recruiting
7
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
8
CS Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
10
Cleveland Clinic Children's Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
11
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
Monroe Carrell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
Actively Recruiting
14
Cook Children's Hospital
Fort Worth, Texas, United States, 76104
Actively Recruiting
15
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Mohamed Zidan, MD
CONTACT
K
Kevin K Chung, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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