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New treatment option for Ventilator Associated Pneumonia
Official title Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care
ClinicalTrials.gov ID: NCT05124977
What this study is testing
What is Antimicrobial Stewardship?
Antimicrobial Stewardship is an investigational medicine, given as an once-daily, being studied as a potential treatment for ventilator associated pneumonia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Increasing emergence of multidrug resistant (MDR) bacteria worldwide is now considered one of the most urgent threats to global health. The association between increase of antibiotics consumption and resistance emergence has been well documented for all patients admitted to the Intensive care unit (ICU) who received antibiotic treatment and for patients treated for ventilator associated pneumonia (VAP).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of microbiologically confirmed of first episode of VAP
- Initial appropriate antibiotic therapy (whether empirical or not)
- Written informed consent from the patient or a legal representative if appropriate. If absence of a legal representative the patient may be included...
- Patient under MV\>48 hours at the time of the microbiological sampling
- New pulmonary infiltrate of which an infectious origin is strongly suspected
You likely can't join if
- Patient under selective decontamination of the digestive tract
- Duration of antibiotic therapy prior to inclusion \> 72h (for any reason) appropriate to the germs found in the bacterial documentation of the first...
- Inclusion in another treatment study concerning antimicrobial strategies
- Moribund (IGS II\>80)
- Thoracic trauma with Abbreviated Injury Scale (AIS) thorax ≥ 3
- Severely immunocompromised patients (such as congenital immunodeficiency, neutropenia (\<1leucocyte/ml or \<0.5 neutrophil/ml) or acute hematologic...
See the full eligibility criteria
- Diagnosis of microbiologically confirmed of first episode of VAP
- Initial appropriate antibiotic therapy (whether empirical or not)
- Written informed consent from the patient or a legal representative if appropriate. If absence of a legal representative the patient may be included in emergency procedure Definitive diagnosis of pneumonia (in agreement...
- Patient under MV\>48 hours at the time of the microbiological sampling
- New pulmonary infiltrate of which an infectious origin is strongly suspected
- Worsening oxygenation
- Have the following clinical criteria within the 24 hours prior to the first dose of antibiotic therapy
- Purulent tracheal secretions
- And at least 1 of the following : documented fever (body temperature \>38,3°C) or hypothermia (body temperature \ 10,000 cells/mm3 or \<4,000 cells/mm3
- Microbiological criteria (positive quantitative culture of a lower respiratory tract (LRT): bronchoalveolar lavage fluid (BAL) (significant threshold ≥10\^4 colony-forming units/mL) or plugged telescopic catheter (PTC)...
- Patient under selective decontamination of the digestive tract
- Duration of antibiotic therapy prior to inclusion \> 72h (for any reason) appropriate to the germs found in the bacterial documentation of the first episode of VAP
- Inclusion in another treatment study concerning antimicrobial strategies
- Moribund (IGS II\>80)
- Thoracic trauma with Abbreviated Injury Scale (AIS) thorax ≥ 3
- Severely immunocompromised patients (such as congenital immunodeficiency, neutropenia (\<1leucocyte/ml or \<0.5 neutrophil/ml) or acute hematologic malignancy or stem cell transplant, HIV infection with CD4 count below...
- Patients undergoing immunosuppressive therapy and long term corticotherapy \> 0.5 mg/kg
- VAP due to: Pseudomonas aeruginosa, Carbapenem-resistant Acinetobacter spp, Carbapenem-resistant Enterobacteriaceae
- VAP occurring in the context of co-infection of COVID-19 or other viral pneumonia (confirmed by RT-PCR)
- Patients with empyema, necrotizing and abscessed pneumonia
- Patients requiring extracorporeal oxygen therapy (ECMO), either veno-venous or veno-arterial
- Pregnant women
- No health insurance coverage
The study team makes the final eligibility decision.
Where it's taking place
- Clichy-sous-Bois, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clichy-sous-Bois, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.