Invasive FusariosisNCT04982159
Correlation Between Minimum Inhibitory Concentration and Clinical Outcome of Invasive Fusariosis
An observational study of Invasive Fusariosis, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Multi-centered, international, observational and retrospective study to analyze the correlation between MIC and clinical outcome in patients with invasive fusariosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Invasive Fusariosis
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Hospital patients diagnosed with invasive fusariosis.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Multi-centered, international, observational and retrospective study to analyze the correlation between MIC and clinical outcome in patients with invasive fusariosis.
- Conditions
- Invasive Fusariosis
- Being tested
- There is no intervention. This is an observational study.
- Keywords
- invasive fusariosis, minimum inhibitory concentration
- Medical subject headings
- Fusariosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention. This is an observational study.Other
There is no intervention. This is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Invasive Fusariosis | Patients hospitalized with an invasive fusariosis diagnostic in the stablished period of study. Receives: Other: There is no intervention. This is an observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evolution
Retrospective evaluation of death rate.
Measured: 6 weeks after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive FusariosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982159
- Sponsor's protocol ID
- FIB-VOR-2019-01
- Status last verified
- May 2022
- First submitted
- 6 Jul 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after the study concludes and results are published.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Minimum Inhibitory Concentration and Clinical Outcome of Invasive Fusariosis
- ClinicalTrials.gov ID
- NCT04982159
- Acronym / sponsor ID
- FIB-VOR-2019-01
- Conditions
- Invasive Fusariosis
- Keywords
- invasive fusariosis, minimum inhibitory concentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-centered, international, observational and retrospective study to analyze the correlation between MIC and clinical outcome in patients with invasive fusariosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasive Fusariosis | – | Other: There is no intervention. This is an observational study.Patients hospitalized with an invasive fusariosis diagnostic in the stablished period of study. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital patients diagnosed with invasive fusariosis.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no intervention. This is an observational study.There is no intervention. This is an observational study. | Other | Invasive Fusariosis |
Primary outcome
Clinical Evolution
Time frame: 6 weeks after diagnosis
Retrospective evaluation of death rate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: Yes. Data will be shared after the study concludes and results are published.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fusariosis, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Evolution (time frame: 6 weeks after diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.