ManagemEnt of Antifungal Drug in Invasive Aspergillosis：a... | NCT06028451

Studies
ManagemEnt of Antifungal Drug in Invasive Aspergillosis：a Real-word Study

NCT06028451

Sponsor

Southeast University, China

Status

Unknown status

Last Update Posted

Oct 10, 2023Actual

Enrollment

550Estimated

Phase

Not provided

Conditions

Invasive Aspergillosis

Interventions

Record the information data

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

Oct 2023

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

Sep 25, 2023Actual

Primary Completion Date

Sep 15, 2024Estimated

Completion Date

Dec 15, 2024Estimated

First Submitted Date

Aug 31, 2023

First Submission Date that Met QC Criteria

Aug 31, 2023

First Posted Date

Sep 8, 2023Actual

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

Oct 7, 2023

Last Update Posted Date

Oct 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jingyuan,Xu, Principal Investigator, Southeast University, ChinaPrincipal Investigator

Lead Sponsor

Southeast University, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

To assessed the current situation and outcome of critically ill patients with invasive aspergillus infection.

Detailed Description

To assessed the current situation and outcome of critically ill patients with invasive aspergillus infection.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

90 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

550Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Survivors		Critically ill patients with invasive aspergillus infection who survived	Other: Record the information data
Nonsurvivors		Critically ill patients with invasive aspergillus infection who not survived	Other: Record the information data

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Record the information data	Other	Record the information data	Nonsurvivors Survivors

Measure	Description	Time Frame
mortality		28 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age>18 year-old
Diagosed as invasive aspergillus infection

Exclusion Criteria:

Pregnant

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 diagosed as invasive aspergillosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jingyuan Xu, M.D.	Contact	8613851417209		13851417209@163.com
Jingyuan Xu, M.D.	Contact	13851417209		13851417209@163.com

Overall Officials

Name	Affiliation	Role
Jingyuan Xu, M.D.	Southeast University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southeast University, Zhongda hospital	Recruiting	Nanjing	Jiangsu	210000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided