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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04923828
Other study ID # fdpicu-21
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 31, 2023
Est. completion date December 31, 2026

Study information

Verified date February 2024
Source Children's Hospital of Fudan University
Contact Guoping Lu, Doctor
Phone 13788904150
Email 13788904150@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To investigate PICUs in major cities in China by establishing a high-quality standardized clinical database of PICU inpatients Incidence, fatality rate, pathogen distribution, anti-infective treatment of community-acquired/nosocomial infections in inpatients.


Description:

All patients admitted to the PICU during January 1, 2016 to December 31 2025 were included in the study, and all patients were followed up until death or PICU withdrawal. To establish the standardized Access database collected patients' general information, infection, PICU treatment, catheter, and short-term Prognosis and other clinical data.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Month to 16 Years
Eligibility Inclusion Criteria: - PICU patients with severe infection Exclusion Criteria: - Non-infected patient

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Children's Hospital of Fudan University Shanghai Shanghai

Sponsors (8)

Lead Sponsor Collaborator
Guoping Lu Anhui Provincial Children's Hospital, Ningbo Women & Children's Hospital, Qilu Children's Hospital of Shandong University, Shanghai Children's Hospital, Shanghai Children's Medical Center, The Children's Hospital of Zhejiang University School of Medicine, Xian Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pathogenic spectrum of PICU severe infection the 10 years of pathogenic spectrum of PICU severe infection 2016-2025
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