Bacterial Colonization in Tracheostomized Patients With Neurological or Neuromuscular Disease

Respiratory Tract Infections Clinical Trial

— ECOTRACH  

Official title:

Study of Bacterial Colonization of the Respiratory Tract in Long-term Tracheostomized Patients With Neurological or Neuromuscular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400086
• Other study ID #: 15004
• Status: Completed
• Start date: February 2015
• Est. completion date: January 2018

Study information

• Verified date: January 2020
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disorder of Trachea
• Mechanical Ventilation Complication
• Neuromuscular Diseases
• Respiratory Tract Infections
• Tracheal Diseases

Locations

Country	Name	City	State
France	Hôpital Raymond Poincaré	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

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