Surveillance of Fungal Infections During Construction Act... | NCT00473252

Studies
Surveillance of Fungal Infections During Construction Activity

NCT00473252

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

May 20, 2011Estimated

Enrollment

340Actual

Phase

Not provided

Conditions

Aspergillosis

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

May 14, 2007

First Submission Date that Met QC Criteria

May 14, 2007

First Posted Date

May 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2011

Last Update Posted Date

May 20, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Fungal infections in immunocompromised patients occuring during construction activities in hospitals have repeatedly been reported.

However, the question of a causal relation between construction activities and infections has never been addressed systematically and prospectively.

To answer this question, we will monitor our immunosuppressed patients' health status, as well as fine dust and aspergillus spore contents in the air during a three year construction activity period in our hospital.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

340Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Kidney transplantation
Chronic hemodialysis treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Prevalent hemodialysis patients and incident renal transplant recipients in the Department of Nephrology and Hypertension, University Hospital Bern, Switzerland

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Pasch, MD	University of Bern	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. Nephrology & Hypertension, Univ. Hospital Bern		Bern	Canton of Bern	3010	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D001228	Aspergillosis

Ancestor Terms

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Hemodialysis patients
Renal transplant patients