Correlation Between Minimum Inhibitory Concentration and Clinical Outcome of Invasive Fusariosis

Sponsor

Maimónides Biomedical Research Institute of Córdoba (Other)

Overall Status

Completed

CT.gov ID

NCT04982159

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Invasive Fusariosis	Other: There is no intervention. This is an observational study.

Study Design

Study Type:

Observational

Actual Enrollment :

11 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Correlation Between Minimum Inhibitory Concentration and Clinical Outcome of Invasive Fusariosis

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
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. There is no intervention. This is an observational study.

Arm

Intervention/Treatment

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.

There is no intervention. This is an observational study.

Outcome Measures

Primary Outcome Measures

Clinical Evolution [6 weeks after diagnosis]
Retrospective evaluation of death rate.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Reina Sofía	Córdoba		Spain	14004

Sponsors and Collaborators

Maimónides Biomedical Research Institute of Córdoba

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Link to article with the results of the whole trial.

Publications

None provided.

Responsible Party:

Maimónides Biomedical Research Institute of Córdoba

ClinicalTrials.gov Identifier:

NCT04982159

Other Study ID Numbers:

FIB-VOR-2019-01

First Posted:

Jul 29, 2021

Last Update Posted:

Jun 2, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maimónides Biomedical Research Institute of Córdoba

invasive fusariosis

minimum inhibitory concentration

Additional relevant MeSH terms:

Fusariosis

Study Results

No Results Posted as of Jun 2, 2022