Correlation Between Minimum Inhibitory Concentration and... | NCT04982159

Studies
Correlation Between Minimum Inhibitory Concentration and Clinical Outcome of Invasive Fusariosis

NCT04982159

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Status

Completed

Last Update Posted

Jun 2, 2022Actual

Enrollment

11Actual

Phase

Not provided

Conditions

Invasive Fusariosis

Interventions

There is no intervention. This is an observational study.

Countries

Spain

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

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jul 6, 2021

First Submission Date that Met QC Criteria

Jul 19, 2021

First Posted Date

Jul 29, 2021Actual

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

May 27, 2022

Last Update Posted Date

Jun 2, 2022Actual

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

Multi-centered, international, observational and retrospective study to analyze the correlation between MIC and clinical outcome in patients with invasive fusariosis.

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Invasive Fusariosis		Patients hospitalized with an invasive fusariosis diagnostic in the stablished period of study.	Other: There is no intervention. This is an observational study.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
There is no intervention. This is an observational study.	Other	There is no intervention. This is an observational study.	Invasive Fusariosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Evolution	Retrospective evaluation of death rate.	6 weeks after diagnosis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Invasive fusariosis diagnostic
Proof of anti-fungic susceptibility according to EUCAST or CLSI, for the medicine used in the treatment of invasive fusariosis.
Available data about anti-fungic medicines used: name of medicine, start and end date of treatment.
Available information about clinical outcome of illness after 30 days, 6 weeks and 90 days (dead or alive).
Only cases of invasive fusariosis proven or possible will be included.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hospital patients diagnosed with invasive fusariosis.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Reina Sofía		Córdoba		14004	Spain

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data will be shared after the study concludes and results are published.

Types

Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

When study is published.

Access Criteria

Through request to Principal Investigator.

URL

https://pubmed.ncbi.nlm.nih.gov/33326585/

Condition Browse Module

MeSH Terms

ID	Term
D060585	Fusariosis

Ancestor Terms

ID	Term
D060605	Hyalohyphomycosis
D003881	Dermatomycoses
D009181	Mycoses
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided