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WithdrawnNCT04821414Updated Jun 15, 2022

Effects of IL-1β and Its Receptor Antagonists in the Treatment of Severe Infection and Inflammatory Storm in Children

An observational study in Critical Illness and Sepsis, Severe, sponsored by Children's Hospital of Fudan University. Withdrawn. Open to participants aged 29 Days to 18 Years. Per ClinicalTrials.gov, last updated 2022-06-15.

Sponsored by Children's Hospital of Fudan University · Observational

Why this study was withdrawn
Lacking of funding
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
29 Days to 18 Years
Sex
All
01

Study summary

In severe infective patients who survive the initial inflammatory storm, the immune response often evolves toward a state of immunosuppression, which contributes to increased mortality and severe secondary hospital-acquired infections. However, the role of IL-1β and its receptor antagonists in patients with severe sepsis and septic shock is discussed controversially. To date, the efficacy and safety of IL-1β and its receptor antagonists in children with severe infection is not fully evaluated.

Read the detailed description

The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit of Children's Hospital of Fudan University from January 2022 to December 2023. Children with a PICU length of day less than 48h will be excluded. Patients who met the inclusion criteria will be divided into trial group and control group. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record.

02

Conditions studied

  • Critical Illness
  • Sepsis, Severe

Keywords

  • Critical Illness
  • Sepsis
  • anakinra
  • canakinumab
  • children
03

In context

Sepsis

1,894 studies on the registry are indexed under Sepsis; 458 are open to participants now.

Browse Sepsis studies →

Lead sponsor

Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
29 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All children hospitalized in PICU of Children's Hospital of Fudan University from January 2022 to December 2023

Inclusion criteria

  • Children between 29 days and 18 years old.
  • Severe pneumonia and/or sepsis.
  • Patients were included who meet the guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019) issued by the National Health Commission of the people's Republic of China and/or who meet the International Guide to the 2020 campaign to Save sepsis: management of septic shock and sepsis-related organ dysfunction in children.

Exclusion criteria

Exclusion Criteria:

  • Notifiable infectious diseases.
  • The researcher believes that he is not suitable to participate in other situations in this study.
  • Participants in other clinical trials in the same period.
  • Discharge within 48 hours
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • trial group

    anakinra canakinumab

  • control group

    conventional treatment

06

What researchers measure

Primary outcomes

  1. survival rate

    The death rate of children in 28 days after their discharged from PICU

    Time frame: within 28 days after they discharged from PICU

Secondary outcomes

  1. length of stay in PICU

    Time from PICU admission to discharge

    Time frame: within 28 days after they discharged from PICU

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04821414
Lead sponsor
Children's Hospital of Fudan University
Responsible party
Sponsor
First posted
Mar 29, 2021
Start date
Sep 1, 2022 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jun 15, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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