NCT02407275

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

March 30, 2015

Last Update Submit

March 30, 2015

Conditions

SinusitisChronic DiseaseRefractory

Outcome Measures

Primary Outcomes (1)

  • Sinusian microbiota description

    species, number and type of isolated microbes

    6 months

Study Arms (1)

biological sample

OTHER

Genomic \& culturomic analyses

Other: Biological sample

Interventions

Biological sampleOTHER
biological sample

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \<18 year old
  • pregnant women
  • breastfeeding
  • under trusteeship
  • under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service ORL et de Chirurgie Cervico - Faciale/ AP-HM

Marseille, France

RECRUITING

MeSH Terms

Conditions

SinusitisChronic Disease

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre-Edouard Fournier, Professor

    IHU Méditerranée Infection

    STUDY CHAIR

Central Study Contacts

Erwan Le Dault

CONTACT

0033699662257erwan.le.dault@gmail.com

Pierre-Edouard Fournier, Professor

CONTACT

pierre-edouard.fournier@univ-amu.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2015

Last Updated

April 2, 2015

Record last verified: 2015-03

Locations

FR(1)