NCT00906633

Brief Summary

This trial is an observational study about combination antifungal therapy in hematologic patients with proven and probable invasive fungal infections (IFI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 26, 2010

Status Verified

May 1, 2009

Enrollment Period

11 months

First QC Date

May 19, 2009

Last Update Submit

January 25, 2010

Conditions

Fungal Infection

Keywords

antifungal therapies

Outcome Measures

Primary Outcomes (1)

  • safety, efficacy and duration of therapy

    one year

Study Arms (1)

Outcome of combination antifungal therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Haematologic patients with proven or probable invasive fungal infectious

You may qualify if:

  • Haematologic patients with proven or probable IFI
  • Therapy with a combination of antifungal drugs

You may not qualify if:

  • Haematologic patients with possible IFI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Udine

Udine, 33100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 24373120DERIVED

MeSH Terms

Conditions

Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • ANNA CANDONI, MD

    University Hospital, Udine, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 21, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

January 26, 2010

Record last verified: 2009-05

Locations

IT(1)