QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

Launched by SEASTAR MEDICAL · Jul 18, 2024

Keywords

ClinConnect Summary

The QUELIMMUNE study is designed to gather information about the safety of a treatment called QUELIMMUNE for children and young adults aged 22 years or younger who are experiencing acute kidney injury (AKI) due to sepsis, a serious infection. Sepsis can lead to kidney problems, and QUELIMMUNE is being used to help these patients who are also receiving antibiotics and may need kidney support. This registry will compare the number of new bloodstream infections that occur in the first 28 days after starting QUELIMMUNE with a similar group of patients who are being treated for sepsis but are not receiving QUELIMMUNE.

To participate in this trial, patients need to be at least 10 kilograms in weight and 22 years old or younger. Unfortunately, those who weigh less than 10 kilograms, are older than 22, or have a known allergy to any part of QUELIMMUNE cannot join. If a patient becomes part of this study, they can expect to be monitored closely for safety and any changes in their health over the course of their treatment. This study is currently looking for participants, and it aims to help improve understanding of how QUELIMMUNE works in children with these serious health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All patients initiated on QUELIMMUNE therapy under the HDE-approved indication
• Exclusion Criteria:
• • Weight \<10kg
• • Age \>22 years
• • Known allergy to any components of QUELIMMUNE