Infectious Disorder of TracheaECOTRACHNCT02400086
Bacterial Colonization in Tracheostomized Patients With Neurological or Neuromuscular Disease
An observational study of Infectious Disorder of Trachea and Respiratory Tract Infections, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Patients with neurological or neuromuscular diseases may need a long-term tracheostomy to improve their respiratory function. Bacterial flora and bacterial drug resistance in the respiratory tract have never been studied until then for this type of patient in spite of their frequent hospital stay, their regular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Disorder of Trachea, Respiratory Tract Infections, Mechanical Ventilation Complication
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Jan 2018
- Phase
- Observational
- 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
Study population: patients with a long-term tracheostomy and suffering from a neurological or neuromuscular disease
Who may be able to join
- Patient of majority age who signed the information note
- Tracheostomized patient for more than 6 months for a neurological or neuromuscular disease leaving in the community and hospitalized in Raymond Poincaré hospital for less than 48 hours
Who cannot join
- Refusal to take part of the study
- Not membership in a national insurance scheme
- Patient under guardianship or curatorship
- More than 48 hours hospitalization before tracheal aspirate
- Hospitalization in the previous month
- Evolutionary pneumonia at the admission or in the previous month (fever >38.4°C with respiratory signs of pneumonia as cough, increase of the dyspnea, increase of expectorations associated with radiological opacities of recent appearance)
- Non-chronical antibiotic treatment in the previous month
- Patient already included during a previous hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Bacterial Colonization of the Respiratory Tract in Long-term Tracheostomized Patients With Neurological or Neuromuscular Disease
Patients with neurological or neuromuscular diseases may need a long-term tracheostomy to improve their respiratory function. Bacterial flora and bacterial drug resistance in the respiratory tract have never been studied until then for this type of patient in spite of their frequent hospital stay, their regular exposition to antibiotics and their susceptibility to swallowing disorders due to their pathology. This study is based on a single tracheal aspirate within the 48 first hours of the patient stay for a ventilation check up beside any infectious context to describe the basal bacterial respiratory flora.
Read the detailed description
At their admission in Raymond Poincaré hospital in the long-term ventilation unit for a ventilation check-up, patients with a long-term tracheostomy and suffering from a neurological or neuromuscular disease will be included in the study if they have no sign of pneumonia and no contact with a hospital structure within a month. These exclusion criteria allow to focus on non-decompensating patient with a respiratory flora not hospital-acquired and not modified by antibiotics.
The doctor in charge of the patient will fill a questionnaire with the help of the patients or the patient's family with several items as date of tracheostomy, history of respiratory infections, history of hospitalization, characteristics of ventilation (presence of a cannula, frequency of change of filter, type of water use in the humidifier…). Beside, a tracheal aspirate will be collected and send to the microbiology laboratory for bacterial culture. The tracheal aspirate will be supported as a usual clinical tracheal aspirate but each bacterial specie will be quantify and identify by mass spectrometry. Antimicrobial susceptibility testing will be performed only for potential pathogenic species with a cut-off at 105.
- Conditions
- Infectious Disorder of Trachea, Respiratory Tract Infections, Mechanical Ventilation Complication
- Keywords
- neuroligical or neuromuscular diseases, bacterial respiratory tract flora, long term tracheostomy
- Medical subject headings
- Respiratory Tract Infections, Neuromuscular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the bacterial flora of the respiratory tract identify by tracheal aspirate at the hospital admission of long-term tracheostomized patients
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious Disorder of TracheaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaux Lepainteur, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400086
- Sponsor's protocol ID
- 15004
- Acronym
- ECOTRACH
- Status last verified
- Jan 2020
- First submitted
- 23 Mar 2015
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Bacterial Colonization of the Respiratory Tract in Long-term Tracheostomized Patients With Neurological or Neuromuscular Disease
- ClinicalTrials.gov ID
- NCT02400086
- Acronym / sponsor ID
- ECOTRACH / 15004
- Conditions
- Infectious Disorder of Trachea, Respiratory Tract Infections, Mechanical Ventilation Complication
- Keywords
- neuroligical or neuromuscular diseases, bacterial respiratory tract flora, long term tracheostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 26 Mar 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.
Patients with neurological or neuromuscular diseases may need a long-term tracheostomy to improve their respiratory function. Bacterial flora and bacterial drug resistance in the respiratory tract have never been studied until then for this type of patient in spite of their frequent hospital stay, their regular exposition to antibiotics and their susceptibility to swallowing disorders due to their pathology. This study is based on a single tracheal aspirate within the 48 first hours of the patient stay for a ventilation check up beside any infectious context to describe the basal bacterial respiratory flora.
Detailed description
At their admission in Raymond Poincaré hospital in the long-term ventilation unit for a ventilation check-up, patients with a long-term tracheostomy and suffering from a neurological or neuromuscular disease will be included in the study if they have no sign of pneumonia and no contact with a hospital structure within a month. These exclusion criteria allow to focus on non-decompensating patient with a respiratory flora not hospital-acquired and not modified by antibiotics.
The doctor in charge of the patient will fill a questionnaire with the help of the patients or the patient's family with several items as date of tracheostomy, history of respiratory infections, history of hospitalization, characteristics of ventilation (presence of a cannula, frequency of change of filter, type of water use in the humidifier…). Beside, a tracheal aspirate will be collected and send to the microbiology laboratory for bacterial culture. The tracheal aspirate will be supported as a usual clinical tracheal aspirate but each bacterial specie will be quantify and identify by mass spectrometry. Antimicrobial susceptibility testing will be performed only for potential pathogenic species with a cut-off at 105.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a long-term tracheostomy and suffering from a neurological or neuromuscular disease
Key inclusion criteria (2 listed)
- Patient of majority age who signed the information note
- Tracheostomized patient for more than 6 months for a neurological or neuromuscular disease leaving in the community and hospitalized in Raymond Poincaré hospital for less than 48 hours
Key exclusion criteria (8 listed)
- Refusal to take part of the study
- Not membership in a national insurance scheme
- Patient under guardianship or curatorship
- More than 48 hours hospitalization before tracheal aspirate
- Hospitalization in the previous month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the bacterial flora of the respiratory tract identify by tracheal aspirate at the hospital admission of long-term tracheostomized patients
Time frame: 24 hours
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 27 Jan 2020.
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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.
Margaux Lepainteur, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disorder of Trachea and Respiratory Tract Infections, run by Centre d'Investigation Clinique et Technologique 805 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 2 inclusion and 8 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 27 Jan 2020. 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?
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?
Description of the bacterial flora of the respiratory tract identify by tracheal aspirate at the hospital admission of long-term tracheostomized patients (time frame: 24 hours). 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 27 Jan 2020.