Critical IllnessNCT04821414
Effects of IL-1β and Its Receptor Antagonists in the Treatment of Severe Infection and Inflammatory Storm in Children
An observational study of Critical Illness and Sepsis, Severe, run by Children's Hospital of Fudan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Critical Illness, Sepsis, Severe
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children hospitalized in PICU of Children's Hospital of Fudan University from January 2022 to December 2023
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
- Conditions
- Critical Illness, Sepsis, Severe
- Keywords
- Critical Illness, Sepsis, anakinra, canakinumab, children
- Medical subject headings
- Critical Illness, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| trial group | anakinra canakinumab | |
| control group | conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
The death rate of children in 28 days after their discharged from PICU
Measured: within 28 days after they discharged from PICU
Secondary outcomes (1)
length of stay in PICU
Time from PICU admission to discharge
Measured: within 28 days after they discharged from PICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Sep 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Lacking of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821414
- Sponsor's protocol ID
- fdpicu-19
- Status last verified
- Jun 2022
- First submitted
- 26 Mar 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of IL-1β and Its Receptor Antagonists in the Treatment of Severe Infection and Inflammatory Storm in Children
- ClinicalTrials.gov ID
- NCT04821414
- Acronym / sponsor ID
- fdpicu-19
- Conditions
- Critical Illness, Sepsis, Severe
- Keywords
- Critical Illness, Sepsis, anakinra, canakinumab, children
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lacking of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial group | – | –anakinra canakinumab |
| control group | – | –conventional treatment |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children hospitalized in PICU of Children's Hospital of Fudan University from January 2022 to December 2023
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
survival rate
Time frame: within 28 days after they discharged from PICU
The death rate of children in 28 days after their discharged from PICU
1 secondary outcome
length of stay in PICU
Time frame: within 28 days after they discharged from PICU
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Sepsis, Severe, run by Children's Hospital of Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: within 28 days after they discharged from PICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.