A Case-control Study on the Clinical Characteristics of 28-day and 90-day Death From Severe Anthrax

Anthrax Clinical Trial

Official title:

A Case-control Study on the Clinical Characteristics of 28-day and 90-day Death From Severe Anthrax

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365073
• Other study ID #: TJIRB20231276
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Anthrax

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