Otorhinolaryngologic DiseasesTapPASNCT02751658
Tap to "Tap", Pathobiome Associates Health Care
A study testing mouth swab in people with Otorhinolaryngologic Diseases, run by University Hospital, Montpellier.
Trial summary
The bacteria live in community and in some cases it is the combination of several microorganisms that facilitates transmission and pathogenicity. The concept of pathobiome follows from this finding. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Otorhinolaryngologic Diseases
- What is being tested?
- mouth swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- No sites listed yet
- Study dates
- 8 Nov 2016to 29 Jul 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in the Otorhinolaryngology department
Who cannot join
- Immunocompromised patients
- Patient Opposition to enter the research protocol
About this study
Official title: Pathobiomes Training in the Care of Water Sources and Dynamics of Water-borne Pathogens Involved in Healthcare Associated Infections
The bacteria live in community and in some cases it is the combination of several microorganisms that facilitates transmission and pathogenicity. The concept of pathobiome follows from this finding. Investigators hypothesize that the microbial community water point is a pathobiome influencing installation and transmission of pathogens associated with care
Read the detailed description
Goals :
Key: To study the impact of bacterial communities on the risk of transmission of waterborne pathogenic bacterium Pseudomonas aeruginosa in patients hospitalized from a contaminated water source by this bacterium.
secondary:
- Assess the role of communities on installing the water points in P. aeruginosa by comparing contaminated and uncontaminated water sources.
- To evaluate the effect of the quality of water and the conditions of use of water points network on the composition of bacterial communities associated or not with P. aeruginosa.
Experimental Study conducted from 6 points of water, contaminated deliberately experimental backs onto the project to assess conventional and alternative measures decontamination network and water points
- Conditions
- Otorhinolaryngologic Diseases
- Being tested
- mouth swab
- Medical subject headings
- Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mouth swabOther
Levy to make inside of the mouth with a swab on the day of admission to hospital and the day of release at the patients in the Otorhinolaryngology
| Study group | Role | What they receive |
|---|---|---|
| patients in the Otorhinolaryngology | Other | patients in the Otorhinolaryngology department realization of a levy into the mouth swab on the day of admission to hospital and the day of release Receives: Other: mouth swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Pseudomonas aeruginosa
The presence of Pseudomonas aeruginosa will be made from a buccal swab in all patients admitted to the hospital entrance.
Mark of Pseudomonas aeruginosa will be done with and without trypticase soy broth enrichment and isolation on selective agar cetrimide Pseudomonas aeruginosa . The enrichment will detect a port at very low inoculum knowing that the purpose of the analysis is to detect passing of Pseudomonas aeruginosa from the environment to the patient regardless of the associated infectivity. The identification of certainty will be carried out by MALDI-TOF. If several morphotypes are visualized on agar Cetrimide they will all be identified and kept under custody broth at -20 ° C.
Measured: Entrance hospitalization (Day 1)
Secondary outcomes (1)
Presence of infection with Pseudomonas aeruginosa
The presence of Pseudomonas aeruginosa will be made from a buccal swab in all patients exit hospitalization.
Mark of Pseudomonas aeruginosa will be done with and without trypticase soy broth enrichment and isolation on selective agar cetrimide Pseudomonas aeruginosa . The enrichment will detect a port at very low inoculum knowing that the purpose of the analysis is to detect passing of Pseudomonas aeruginosa from the environment to the patient regardless of the associated infectivity. The identification of certainty will be carried out by MALDI-TOF. If several morphotypes are visualized on agar Cetrimide they will all be identified and kept under custody broth at -20 ° C.
Measured: Exit hospitalization (Day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start8 Nov 2016
- Primary completion18 Dec 2017
- Study completion29 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Otorhinolaryngologic DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara ROMANO-BERTRAND, MCU-PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751658
- Sponsor's protocol ID
- 9648
- Acronym
- TapPAS
- Status last verified
- Jul 2019
- First submitted
- 4 Mar 2016
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Benigno V, Carraro N, Sarton-Loheac G, Romano-Bertrand S, Blanc DS, van der Meer JR. Diversity and evolution of an abundant ICEclc family of integrative and conjugative elements in Pseudomonas aeruginosa. mSphere. 2023 Dec 20;8(6):e0051723. doi: 10.1128/msphere.00517-23. Epub 2023 Oct 30.
PubMed 37902330Virieux-Petit M, Hammer-Dedet F, Aujoulat F, Jumas-Bilak E, Romano-Bertrand S. From Copper Tolerance to Resistance in Pseudomonas aeruginosa towards Patho-Adaptation and Hospital Success. Genes (Basel). 2022 Feb 4;13(2):301. doi: 10.3390/genes13020301.
PubMed 35205346
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathobiomes Training in the Care of Water Sources and Dynamics of Water-borne Pathogens Involved in Healthcare Associated Infections
- ClinicalTrials.gov ID
- NCT02751658
- Acronym / sponsor ID
- TapPAS / 9648
- Conditions
- Otorhinolaryngologic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 26 Apr 2016 (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.
The bacteria live in community and in some cases it is the combination of several microorganisms that facilitates transmission and pathogenicity. The concept of pathobiome follows from this finding. Investigators hypothesize that the microbial community water point is a pathobiome influencing installation and transmission of pathogens associated with care
Detailed description
Goals :
Key: To study the impact of bacterial communities on the risk of transmission of waterborne pathogenic bacterium Pseudomonas aeruginosa in patients hospitalized from a contaminated water source by this bacterium.
secondary:
- Assess the role of communities on installing the water points in P. aeruginosa by comparing contaminated and uncontaminated water sources.
- To evaluate the effect of the quality of water and the conditions of use of water points network on the composition of bacterial communities associated or not with P. aeruginosa.
Experimental Study conducted from 6 points of water, contaminated deliberately experimental backs onto the project to assess conventional and alternative measures decontamination network and water points
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients in the Otorhinolaryngology | Other | Other: mouth swabpatients in the Otorhinolaryngology department realization of a levy into the mouth swab on the day of admission to hospital and the day of release |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in the Otorhinolaryngology department
Key exclusion criteria (2 listed)
- Immunocompromised patients
- Patient Opposition to enter the research protocol
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 |
|---|---|---|
| mouth swabLevy to make inside of the mouth with a swab on the day of admission to hospital and the day of release at the patients in the Otorhinolaryngology | Other | patients in the Otorhinolaryngology |
Primary outcome
Presence of Pseudomonas aeruginosa
Time frame: Entrance hospitalization (Day 1)
The presence of Pseudomonas aeruginosa will be made from a buccal swab in all patients admitted to the hospital entrance. Mark of Pseudomonas aeruginosa will be done with and without trypticase soy broth enrichment and isolation on selective agar cetrimide Pseudomonas aeruginosa . The enrichment will detect a port at very low inoculum knowing that the purpose of the analysis is to detect passing of Pseudomonas aeruginosa from the environment to the patient regardless of the associated infectivity. The identification of certainty will be carried out by MALDI-TOF. If several morphotypes are visualized on agar Cetrimide they will all be identified and kept under custody broth at -20 ° C.
1 secondary outcome
Presence of infection with Pseudomonas aeruginosa
Time frame: Exit hospitalization (Day 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Derived from this study: PubMed 37902330Benigno V, Carraro N, Sarton-Loheac G, Romano-Bertrand S, Blanc DS, van der Meer JR. Diversity and evolution of an abundant ICEclc family of integrative and conjugative elements in Pseudomonas aeruginosa. mSphere. 2023 Dec 20;8(6):e0051723. doi: 10.1128/msphere.00517-23. Epub 2023 Oct 30.
- Derived from this study: PubMed 35205346Virieux-Petit M, Hammer-Dedet F, Aujoulat F, Jumas-Bilak E, Romano-Bertrand S. From Copper Tolerance to Resistance in Pseudomonas aeruginosa towards Patho-Adaptation and Hospital Success. Genes (Basel). 2022 Feb 4;13(2):301. doi: 10.3390/genes13020301.
- Individual participant dataSharing planned: Undecided
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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.
Sara ROMANO-BERTRAND, MCU-PH principal investigator
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
A study testing mouth swab in people with Otorhinolaryngologic Diseases, run by University Hospital, Montpellier.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Pseudomonas aeruginosa (time frame: Entrance hospitalization (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02751658, which also lists 2 linked publications.
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 31 Jul 2019.