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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06365073
Other study ID # TJIRB20231276
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 13, 2024
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Tongji Hospital
Contact Qin Ning, professor
Phone 027-83665919
Email qning@vip.sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a clinical, multi-center, retrospective, case-control study. Patients clinically diagnosed with severe anthrax who meet the inclusion and exclusion criteria will be included in this study for analysis. Respiratory, circulation, nerve and other vital signs of patients with severe anthrax during hospitalization were recorded, and clinical data such as blood routine, blood biochemistry, coagulation function, myocardial injury, therapeutic drug use, and survival time of patients were recorded, as well as the survival situation of patients 28 days and 90 days after discharge.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. The typical bacilli with capsules were found in smear examination and culture of various secretions, excretions, blood and cerebrospinal fluid. 2. Multiple organ dysfunction (MODS) in brain, heart, liver, kidney, coagulation or more than one organ failure. Exclusion Criteria: There are other conditions that affect short-term survival.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Qin Ning

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary mortality rates of severe anthrax mortality rates of severe anthrax 28 days and 90 days
Secondary incidence of complications To evaluate the incidence of respiratory, circulatory, neurological, digestive, coagulation and other complications of severe anthrax in hospital
Secondary Peripheral blood biomarkers associated with 28-day and 90-day mortality Peripheral blood biomarkers associated with 28-day and 90-day mortality 28 days and 90 days
Secondary the improvement in 28-day and 90-day mortality with treatment for severe anthrax the improvement in 28-day and 90-day mortality with treatment for severe anthrax 28 days and 90 days
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