Biomodulina T in pediatric septic shock. Exploratory study

Not Applicable

Not yet recruiting

• Conditions: Septic shock; Shock, Septic; Sepsis; Shock; Pathologic Processes; Systemic Inflammatory Response Syndrome; Pediatrics

• Registration Number: RPCEC00000327
• Lead Sponsor: Centro Nacional de Biopreparados (BioCen)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-03
• Study Completion: 2023-05-01
• Results First Posted: 2023-11-01
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients who meet the diagnostic criteria.
2. Patients aged = 29 days and <9 years.
3. Patients whose parents or legal guardians give their consent to participate in the study in writing.

Exclusion Criteria

1. Patients in whom randomization is not possible within the first 24 hours of being diagnosed.
2. Patients with histories of severe allergic reactions and / or generalized severe eczema.
3. Patients with a diagnosis of tumor or autoimmune disease.
4. Patients with a previous diagnosis of primary immunodeficiency.
5. Patients with a solid organ or stem cell transplant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified