Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d' Inhalation (NCT03763799) | Clinical Trial Compass
CompletedNot Applicable
Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d' Inhalation
France266 participantsStarted 2019-09-20
Plain-language summary
The two most common consequences resulting from aspiration are chemical pneumonitis and bacterial aspiration pneumonia. Both entities present with comparable clinical signs and symptoms. In the absence of a reliable clinical or biological marker to differentiate between these two conditions, most patients with suspected aspiration are treated empirically with antibiotics. De-escalation of initial antibiotic treatment is encouraged based on the results of microbiological results, usually performed before starting antimicrobial treatment. However, in most hospitals, 48-72h are required to obtain the results of microbiological cultures, and to de-escalate empirical large spectrum antibiotic treatment.
The use of the Unyvero®, a multiplex PCR-based testing system, for detection of respiratory bacterial pathogens would allow decreasing the percentage of patients with aspiration syndrome who will receive unappropriated antibiotic treatment at Day 3.
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:
* presence of risk factors for aspiration :
* known or likely swallowing dysfunction,
* altered consciousness,
* cardiac arrest,
* difficult intubation
* witnessed aspiration
* symptoms and signs suggestive of lower respiratory tract pathology
* temperature ≥38.5°C or \<36°C
* leukocyte count ≥10 000/µL or \<1500/µL
* purulent sputum or tracheal aspirate.
* new radiographic infiltrate on chest X-ray
* tracheal intubation and mechanical ventilation since less than 48 hours
Exclusion Criteria:
* pregnant women
* refuse to participate to the study
* no informed consent
* documented bacteremia
* septic shock
* severe immunosuppression: leukocytes\<1000/L or neutrophils\<500/L, chemotherapy during the last 3 months, organ transplant with chronic immunosuppressors use, HIV (CD4\<50), and chronic corticosteroid use (\>0.5 mg/kg day for at least one month during the last three months).
* moribund patients (SAPS II \>90).
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
1
The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment
Timeframe: 48 hours after antibiotic treatment initiation