Rhinosinusites Chroniques

Chronic Disease Clinical Trial

Official title:

ETUDE DU MICROBIOTE DES RHINOSINUSITES CHRONIQUES DIFFICILES A TRAITER PAR METAGENOMIQUE ET CULTUROMIQUE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02407275
• Other study ID #: IHU Méditerranée Infections
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2015
• Last updated: March 30, 2015
• Start date: February 2015

Study information

• Verified date: March 2015
• Source: Institut Hospitalo-Universitaire Méditerranée Infection
• Contact: Erwan Le Dault
• Phone: 0033699662257
• Email: erwan.le.dault[@]gmail.com
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Chronic Disease
• Refractory
• Sinusitis

Intervention

Other:
• Biological sample

Locations

Country	Name	City	State
France	Service ORL et de Chirurgie Cervico - Faciale/ AP-HM	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Institut Hospitalo-Universitaire Méditerranée Infection	University Hospital, Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sinusian microbiota description	species, number and type of isolated microbes	6 months	No