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Rhinosinusites Chroniques

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ClinicalTrials.gov Identifier: NCT02407275
Recruitment Status : Unknown
Verified March 2015 by Institut Hospitalo-Universitaire Méditerranée Infection.
Recruitment status was:  Recruiting
First Posted : April 2, 2015
Last Update Posted : April 2, 2015
University Hospital, Marseille
Information provided by (Responsible Party):
Institut Hospitalo-Universitaire Méditerranée Infection

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.

Condition or disease Intervention/treatment
Sinusitis Chronic Disease Refractory Other: Biological sample

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Study Start Date : February 2015
Estimated Primary Completion Date : September 2015

Arm Intervention/treatment
biological sample
Genomic & culturomic analyses
Other: Biological sample

Primary Outcome Measures :
  1. Sinusian microbiota description [ Time Frame: 6 months ]
    species, number and type of isolated microbes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407275

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

Service ORL et de Chirurgie Cervico - Faciale/ AP-HM Recruiting
Marseille, France
Contact: Pierre-Edouard Fournier    04 91 38 55 17    pierre-edouard.fournier@univ-amu.fr   
Sub-Investigator: Pierre-Edouard Fournier         
Principal Investigator: Justin Michel         
Sub-Investigator: Patrick Dessi         
Sub-Investigator: Martin Penicaud         
Sub-Investigator: Michael Achache         
Sub-Investigator: Arnaud Paganelli         
Sponsors and Collaborators
Institut Hospitalo-Universitaire Méditerranée Infection
University Hospital, Marseille
Study Chair: Pierre-Edouard Fournier, Professor IHU Méditerranée Infection

Responsible Party: Institut Hospitalo-Universitaire Méditerranée Infection
ClinicalTrials.gov Identifier: NCT02407275     History of Changes
Other Study ID Numbers: IHU Méditerranée Infections
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: April 2, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases