SinusitisNCT02407275
Rhinosinusites Chroniques
A study testing Biological sample in people with Sinusitis and Chronic Disease, run by Institut Hospitalo-Universitaire Méditerranée Infection at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis, Chronic Disease, Refractory
- What is being tested?
- Biological sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 year old
- chronic refractory rhinosinusitis
- to require middle meatus swab or other sinus sample
- absence of opposition
Who cannot join
- <18 year old
- pregnant women
- breastfeeding
- under trusteeship
- under guardianship
Trial locations and contacts
1 site in 1 country.
Pierre-Edouard Fournier, Professor contact
France1 site, 1 recruiting
- Recruiting
Service ORL et de Chirurgie Cervico - Faciale/ AP-HM
Marseille
Pierre-Edouard Fournier, 04 91 38 55 17, pierre-edouard.fournier@univ-amu.fr
Pierre-Edouard Fournier
About this study
Official title: ETUDE DU MICROBIOTE DES RHINOSINUSITES CHRONIQUES DIFFICILES A TRAITER PAR METAGENOMIQUE ET CULTUROMIQUE
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.
- Conditions
- Sinusitis, Chronic Disease, Refractory
- Being tested
- Biological sample
- Medical subject headings
- Sinusitis, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sampleOther
| Study group | Role | What they receive |
|---|---|---|
| biological sample | Other | Genomic \& culturomic analyses Receives: Other: Biological sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinusian microbiota description
species, number and type of isolated microbes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Hospitalo-Universitaire Méditerranée Infection
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Marseille
- Responsible party
- Sponsor
- Investigators
- Pierre-Edouard Fournier, Professor, Study chair, IHU Méditerranée Infection
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407275
- Sponsor's protocol ID
- IHU Méditerranée Infections
- Status last verified
- Mar 2015
- First submitted
- 30 Mar 2015
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ETUDE DU MICROBIOTE DES RHINOSINUSITES CHRONIQUES DIFFICILES A TRAITER PAR METAGENOMIQUE ET CULTUROMIQUE
- ClinicalTrials.gov ID
- NCT02407275
- Acronym / sponsor ID
- IHU Méditerranée Infections
- Conditions
- Sinusitis, Chronic Disease, Refractory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institut Hospitalo-Universitaire Méditerranée InfectionUniversity, hospital or other
- Collaborators
- University Hospital, Marseille
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (estimated)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biological sample | Other | Other: Biological sampleGenomic \& culturomic analyses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 year old
- chronic refractory rhinosinusitis
- to require middle meatus swab or other sinus sample
- absence of opposition
Key exclusion criteria (5 listed)
- <18 year old
- pregnant women
- breastfeeding
- under trusteeship
- under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sample | Other | biological sample |
Primary outcome
Sinusian microbiota description
Time frame: 6 months
species, number and type of isolated microbes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Edouard Fournier, Professor contact
Pierre-Edouard Fournier, Professor study chair
IHU Méditerranée Infection
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological sample in people with Sinusitis and Chronic Disease, run by Institut Hospitalo-Universitaire Méditerranée Infection at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erwan Le Dault (0033699662257, erwan.le.dault@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinusian microbiota description (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.