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Status unknownNCT02407275Updated Apr 2, 2015

Rhinosinusites Chroniques

An interventional study of Biological sample in Sinusitis, Chronic Disease and Refractory, sponsored by Institut Hospitalo-Universitaire Méditerranée Infection. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-02.

Sponsored by Institut Hospitalo-Universitaire Méditerranée Infection · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sinusitis
  • Chronic Disease
  • Refractory
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • \<18 year old
  • pregnant women
  • breastfeeding
  • under trusteeship
  • under guardianship
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    biological sample

    Genomic \& culturomic analyses

    Other: Biological sample

Interventions

  • OtherBiological sample
05

What researchers measure

Primary outcomes

  1. Sinusian microbiota description

    species, number and type of isolated microbes

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Service ORL et de Chirurgie Cervico - Faciale/ AP-HM
    Marseille, France
    • Pierre-Edouard Fournier · Contact · pierre-edouard.fournier@univ-amu.fr · 04 91 38 55 17
    • Pierre-Edouard Fournier · Sub investigator
    • Justin Michel · Principal investigator
    • Patrick Dessi · Sub investigator
    • Martin Penicaud · Sub investigator
    • Michael Achache · Sub investigator
    • Arnaud Paganelli · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT02407275
Lead sponsor
Institut Hospitalo-Universitaire Méditerranée Infection
Collaborators
University Hospital, Marseille
Responsible party
Sponsor
First posted
Apr 2, 2015
Start date
Feb 2015
Primary completion
Sep 2015 (estimated)
Last update
Apr 2, 2015

Study contacts

Erwan Le Dault
Contact
erwan.le.dault@gmail.com
0033699662257
Pierre-Edouard Fournier, Professor
Contact
pierre-edouard.fournier@univ-amu.fr
Pierre-Edouard Fournier, Professor
study chair · IHU Méditerranée Infection

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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