Respiratory Tract Infections Clinical Trial
— ECOTRACHOfficial title:
Study of Bacterial Colonization of the Respiratory Tract in Long-term Tracheostomized Patients With Neurological or Neuromuscular Disease
NCT number | NCT02400086 |
Other study ID # | 15004 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2015 |
Est. completion date | January 2018 |
Verified date | January 2020 |
Source | Centre d'Investigation Clinique et Technologique 805 |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 77 |
Est. completion date | January 2018 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Raymond Poincaré | Garches |
Lead Sponsor | Collaborator |
---|---|
Centre d'Investigation Clinique et Technologique 805 |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Description of the bacterial flora of the respiratory tract identify by tracheal aspirate at the hospital admission of long-term tracheostomized patients | 24 hours |
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