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

NCT06365073 | Recruiting

• 1 other identifier: TJIRB20231276
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anthrax

Outcome Measures

Primary Outcomes (1)

• mortality rates of severe anthrax

  mortality rates of severe anthrax

  28 days and 90 days

Secondary Outcomes (3)

• incidence of complications

  in hospital

• Peripheral blood biomarkers associated with 28-day and 90-day mortality

  28 days and 90 days

• the improvement in 28-day and 90-day mortality with treatment for severe anthrax

  28 days and 90 days

Study Arms (2)

survival group

Patients who survived in 28 days/90 days

death group

Patients who survived in 28 days/90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with severe anthrax

You may qualify if:

• The typical bacilli with capsules were found in smear examination and culture of various secretions, excretions, blood and cerebrospinal fluid.
• Multiple organ dysfunction (MODS) in brain, heart, liver, kidney, coagulation or more than one organ failure.

You may not qualify if:

• There are other conditions that affect short-term survival.

Sponsors & Collaborators

• Qin Ning: lead

Study Sites (1)

Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Anthrax

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Qin Ning, professor

CONTACT

027-83665919; qning@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: March 13, 2024
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CN (1)