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ASPIC - Antimicrobial Stewardship for Ventilator Associated Pneumonia in Intensive Care
EU CTIS ID: 2024-513327-16-00
What this study is testing
The aim of this study is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of VAP
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patient is ≥18
- 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 VAP (in agreement with international guidelines) is defined by association: - 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) • Hypothermia (body temperature <35°C) • White blood cell (WBC) count >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 ≥104 colony-forming units/mL) or plugged telescopic catheter (PTC) (significant threshold ≥ 103 colony-forming units/mL) or quantitative endotracheal aspirate (ETA) distal pulmonary secretion samples (significant threshold ≥105 colony-forming units/mL)
You likely can't join if
- - Patient under selective decontamination of the digestive tract
- - Patients requiring extracorporeal oxygen therapy (ECMO), either veno-venous or veno-arterial
- - Pregnant women
- - No health insurance coverage
- - 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 interventional study concerning empirical antimicrobial strategies
See the full eligibility criteria
- Adult patient is ≥18
- 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 VAP (in agreement with international guidelines) is defined by association: - 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) • Hypothermia (body temperature <35°C) • White blood cell (WBC) count >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 ≥104 colony-forming units/mL) or plugged telescopic catheter (PTC) (significant threshold ≥ 103 colony-forming units/mL) or quantitative endotracheal aspirate (ETA) distal pulmonary secretion samples (significant threshold ≥105 colony-forming units/mL)
- - Patient under selective decontamination of the digestive tract
- - Patients requiring extracorporeal oxygen therapy (ECMO), either veno-venous or veno-arterial
- - Pregnant women
- - No health insurance coverage
- - 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 interventional study concerning empirical 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 200/mm3)
- - Patients undergoing immunosuppressive therapy or long term corticotherapy > 0.5 mg/kg
- - VAP due to: Pseudomonas aeruginosa, Carbapenem-resistant Acinetobacter spp, Carbapenem-resistant EnterobacteriaceaeBacterial 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.