Rhinosinusites Chroniques | NCT02407275

Studies
Rhinosinusites Chroniques

NCT02407275

Sponsor

Institut Hospitalo-Universitaire Méditerranée Infection

Status

Unknown status

Last Update Posted

Apr 2, 2015Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Sinusitis
Chronic Disease
Refractory

Interventions

Biological 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

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Sep 2015Estimated

Completion Date

Not provided

First Submitted Date

Mar 30, 2015

First Submission Date that Met QC Criteria

Mar 30, 2015

First Posted Date

Apr 2, 2015Estimated

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

Mar 30, 2015

Last Update Posted Date

Apr 2, 2015Estimated

Name	Class
University Hospital, Marseille	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To analyse and describe sinus microbiota, during hard to treat (or refractory) rhinosinusitis, using culturomic and metagenomic methods (i.e. to culture on many different medium of culture to grow hard to cultivate bacteria + to sequence and analyse all DNA contained in samples).

Samples are middle meatus swabs or pus aspiration, done during usually patient following.

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

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
biological sample	Other	Genomic & culturomic analyses	Other: Biological sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological sample	Other		biological sample

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sinusian microbiota description	species, number and type of isolated microbes	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 year old
chronic refractory rhinosinusitis
to require middle meatus swab or other sinus sample
absence of opposition

Exclusion Criteria:

<18 year old
pregnant women
breastfeeding
under trusteeship
under guardianship

Accepts Healthy Volunteers

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

Name	Role	Phone	Extension	Email
Erwan Le Dault	Contact	0033699662257		erwan.le.dault@gmail.com
Pierre-Edouard Fournier, Professor	Contact			pierre-edouard.fournier@univ-amu.fr

Overall Officials

Name	Affiliation	Role
Pierre-Edouard Fournier, Professor	IHU Méditerranée Infection	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service ORL et de Chirurgie Cervico - Faciale/ AP-HM	Recruiting	Marseille			France

Condition Browse Module

MeSH Terms

ID	Term
D012852	Sinusitis
D002908	Chronic Disease

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010254	Paranasal Sinus Diseases
D009668	Nose Diseases

Browse Leaves

Not provided

Browse Branches

Not provided