CompletedNot Applicable

Bacterial Colonization in Tracheostomized Patients With Neurological or Neuromuscular Disease

France77 participantsStarted 2015-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Description of the bacterial flora of the respiratory tract identify by tracheal aspirate at the hospital admission of long-term tracheostomized patients

Timeframe: 24 hours

Trial details

NCT IDNCT02400086

SponsorCentre d'Investigation Clinique et Technologique 805

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-01

View on ClinicalTrials.gov More Infectious Disorder of Trachea trials