Fungal InfectionSEIFEM COMBONCT00906633
Seifem Surveillance of Antifungal Combination Therapy In Hematologic Italian Centers
An observational study of Fungal Infection, run by University Hospital, Udine, Italy at 1 site in Italy.
Trial summary
This trial is an observational study about combination antifungal therapy in hematologic patients with proven and probable invasive fungal infections (IFI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fungal Infection
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to Jan 2010
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Haematologic patients with proven or probable invasive fungal infectious
Who may be able to join
- Haematologic patients with proven or probable IFI
- Therapy with a combination of antifungal drugs
Who cannot join
- Haematologic patients with possible IFI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seifem Observational Study of Antifungal Combination Therapy In Hematologic Italian Centers
This trial is an observational study about combination antifungal therapy in hematologic patients with proven and probable invasive fungal infections (IFI).
- Conditions
- Fungal Infection
- Keywords
- antifungal therapies
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Outcome of combination antifungal therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety, efficacy and duration of therapy
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fungal InfectionStudies 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Udine, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Investigators
- ANNA CANDONI, MD, Principal investigator, University Hospital, Udine, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906633
- Sponsor's protocol ID
- SEIFEMcombo0509
- Acronym
- SEIFEM COMBO
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Candoni A, Caira M, Cesaro S, Busca A, Giacchino M, Fanci R, Delia M, Nosari A, Bonini A, Cattaneo C, Melillo L, Caramatti C, Milone G, Scime' R, Picardi M, Fanin R, Pagano L; SEIFEM GROUP (Sorveglianza Epidemiologica Infezioni Fungine nelle Emopatie Maligne). Multicentre surveillance study on feasibility, safety and efficacy of antifungal combination therapy for proven or probable invasive fungal diseases in haematological patients: the SEIFEM real-life combo study. Mycoses. 2014 Jun;57(6):342-50. doi: 10.1111/myc.12161. Epub 2013 Dec 23.
PubMed 24373120
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seifem Observational Study of Antifungal Combination Therapy In Hematologic Italian Centers
- ClinicalTrials.gov ID
- NCT00906633
- Acronym / sponsor ID
- SEIFEM COMBO / SEIFEMcombo0509
- Conditions
- Fungal Infection
- Keywords
- antifungal therapies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Udine, ItalyUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 21 May 2009 (estimated)
- 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.
This trial is an observational study about combination antifungal therapy in hematologic patients with proven and probable invasive fungal infections (IFI).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outcome of combination antifungal therapy | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Haematologic patients with proven or probable invasive fungal infectious
Key inclusion criteria (2 listed)
- Haematologic patients with proven or probable IFI
- Therapy with a combination of antifungal drugs
Key exclusion criteria (1 listed)
- Haematologic patients with possible IFI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
safety, efficacy and duration of therapy
Time frame: one year
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 26 Jan 2010.
- Derived from this study: PubMed 24373120Candoni A, Caira M, Cesaro S, Busca A, Giacchino M, Fanci R, Delia M, Nosari A, Bonini A, Cattaneo C, Melillo L, Caramatti C, Milone G, Scime' R, Picardi M, Fanin R, Pagano L; SEIFEM GROUP (Sorveglianza Epidemiologica Infezioni Fungine nelle Emopatie Maligne). Multicentre surveillance study on feasibility, safety and efficacy of antifungal combination therapy for proven or probable invasive fungal diseases in haematological patients: the SEIFEM real-life combo study. Mycoses. 2014 Jun;57(6):342-50. doi: 10.1111/myc.12161. Epub 2013 Dec 23.
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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.
ANNA CANDONI, MD principal investigator
University Hospital, Udine, Italy
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 Fungal Infection, run by University Hospital, Udine, Italy at 1 site in Italy.
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 2 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 26 Jan 2010. 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 Italy. 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?
safety, efficacy and duration of therapy (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00906633, which also lists 1 linked publication.
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 26 Jan 2010.