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Rhinosinusites Chroniques

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Institut Hospitalo-Universitaire Méditerranée Infection.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
University Hospital, Marseille
Information provided by (Responsible Party):
Institut Hospitalo-Universitaire Méditerranée Infection
ClinicalTrials.gov Identifier:
NCT02407275
First received: March 30, 2015
Last updated: NA
Last verified: March 2015
History: No changes posted
  Purpose

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 Intervention
Sinusitis
Chronic Disease
Refractory
Other: Biological sample

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: ETUDE DU MICROBIOTE DES RHINOSINUSITES CHRONIQUES DIFFICILES A TRAITER PAR METAGENOMIQUE ET CULTUROMIQUE

Further study details as provided by Institut Hospitalo-Universitaire Méditerranée Infection:

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


Estimated Enrollment: 20
Study Start Date: February 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
biological sample
Genomic & culturomic analyses
Other: Biological sample

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02407275

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

Locations
France
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
Investigators
Study Chair: Pierre-Edouard Fournier, Professor IHU Méditerranée Infection
  More Information

Responsible Party: Institut Hospitalo-Universitaire Méditerranée Infection
ClinicalTrials.gov Identifier: NCT02407275     History of Changes
Other Study ID Numbers: IHU Méditerranée Infections
Study First Received: March 30, 2015
Last Updated: March 30, 2015

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

ClinicalTrials.gov processed this record on May 23, 2017