Wind Instruments' Fungal Contamination | NCT01487850

Studies
Wind Instruments' Fungal Contamination

NCT01487850

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Dec 9, 2011Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Immunologically-induced Lung Disease
Hypersensitivity Pneumonitis

Interventions

blood sample

Countries

France

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

Dec 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 2007

Primary Completion Date

Jun 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Dec 6, 2011

First Submission Date that Met QC Criteria

Dec 7, 2011

First Posted Date

Dec 8, 2011Estimated

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

Dec 8, 2011

Last Update Posted Date

Dec 9, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Flora METZGER, Medical Doctor, Lung specialist, Principal Investigator, Centre Hospitalier Universitaire de BesanconPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire de BesanconOTHER

Collaborators

Not provided

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

On the basis of 2 cases of immunologically-induced lung disease in 2 saxophonists, the investigators supposed that wind reed instruments could be contaminated with molds. The investigators led a study on 40 musicians playing a wind reed instrument to analyze instruments' fungal contamination and its immunological and clinical consequences for musicians.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sample	Biological	blood sample in each musician to search for specific antibodies against molds isolated from instruments

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

must be 18 year old or more
must play a wind reed instrument (saxophone, clarinet, bassoon or oboe) one hour per week or more

Exclusion Criteria:

refuse to sign consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire Saint Jacques		Besançon	Franche Comté	25000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3371127	Result	Lodha S, Sharma OP. Hypersensitivity pneumonitis in a saxophone player. Chest. 1988 Jun;93(6):1322. doi: 10.1378/chest.93.6.1322. No abstract available.
20822994	Result	Metzger F, Haccuria A, Reboux G, Nolard N, Dalphin JC, De Vuyst P. Hypersensitivity pneumonitis due to molds in a saxophone player. Chest. 2010 Sep;138(3):724-6. doi: 10.1378/chest.09-2991.

ID	Term
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis