A Case-control Study on the Clinical Characteristics of 2... | NCT06365073

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

NCT06365073

Sponsor

Qin Ning

Status

Unknown status

Last Update Posted

Apr 15, 2024Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Anthrax

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 13, 2024Actual

Primary Completion Date

Aug 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Apr 10, 2024

First Submission Date that Met QC Criteria

Apr 10, 2024

First Posted Date

Apr 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2024

Last Update Posted Date

Apr 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
survival group		Patients who survived in 28 days/90 days
death group		Patients who survived in 28 days/90 days

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality rates of severe anthrax	mortality rates of severe anthrax	28 days and 90 days

Secondary Outcomes

Measure	Description	Time Frame
incidence of complications	To evaluate the incidence of respiratory, circulatory, neurological, digestive, coagulation and other complications of severe anthrax	in hospital
Peripheral blood biomarkers associated with 28-day and 90-day mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

There are other conditions that affect short-term survival.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with severe anthrax

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qin Ning, professor	Contact	027-83665919		qning@vip.sina.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Recruiting	Wuhan	Hubei		China

Condition Browse Module

MeSH Terms

ID	Term
D000881	Anthrax

Ancestor Terms

ID	Term
D016863	Bacillaceae Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided