NCT02859831

Brief Summary

Fusarium are microscopic filamentous fungi that live as saprobiontics in outside environments. They are found in the soil, the air, in water and on numerous plants. The frequency of fusariosis is currently increasing and Fusarium-related mycoses are the 3rd most frequent invasive mycoses. Most cases have been reported in the United States, in France, in Italy and in Brazil. A few epidemiological studies have shown the role of water in the appearance of mycoses in highly immunodepressed patients. Few studies have focused on the role of water in the transmission of mycoses in hospitals. The aim of this prospective study is to describe, in time and pace, the contamination by Fusarium sp. in the water of two different hospitals (Dijon, Nancy), by taking into account factors such as seasons and major works (reconstruction of a hospital). In each hospital, one reconstruction site will be compared with a site not under reconstruction (control). Water samples will be taken from the rooms of hospitalized patients.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
551

participants targeted

Target at P75+ 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

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
Last Updated

August 9, 2016

Status Verified

July 1, 2016

First QC Date

August 4, 2016

Last Update Submit

August 8, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of Fusarium sp

    every week throughout the study, thus over 3 years

Study Arms (2)

with construction work

Other: water samples

without construction work

Other: water samples

Interventions

with construction workwithout construction work

Eligibility Criteria

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

water samples from the rooms of hospitalized patients in 4 departments of Dijon and Nancy CHU

You may qualify if:

  • all patients with new-onset fusariosis in the Adult Haematology, Internal Medicinie, Digestive Surgery and Rheumatology Departments

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Conditions

Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 9, 2016

Primary Completion

February 1, 2009

Last Updated

August 9, 2016

Record last verified: 2016-07

Locations