Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colon… (NCT02940626) | Clinical Trial Compass
TerminatedPhase 2
Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.
Stopped: As a result of a pre-planned interim analysis for futility
United States, Austria, Czechia155 participantsStarted 2016-11
Plain-language summary
The purpose of this study is the prevention of Staphylococcus aureus pneumonia in mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a human pathogenic bacterium that causes severe infections, including pneumonia and sepsis. Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is an investigational monoclonal antibody product that targets the toxins produced by S. aureus to protect subjects from developing S. aureus pneumonia.
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:
\- Subject is currently hospitalized and is mechanically ventilated endotracheally (i.e., orotracheal or nasotracheal) and, in the Investigator's opinion, will require ongoing ventilator support for at least 48 hours;
Exclusion Criteria:
* Subject has a chest X-ray or thoracic computed tomography (CT) scan that is definitive for a diagnosis of pneumonia
* Subject has a known and documented ETA culture showing heavy colonization with a -Gram-negative organism at enrollment or at any time during the Screening period;
* Significant Neutropenia
* Severe non-pulmonary source of infection.
* Subjects with a known history or current (suspected) diagnosis of cytokine release syndrome associated with the administration of peptides, proteins, and/or antibodies.
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.
1This trial was terminated before it completed — do you know why it was stopped, and does that affect whether ASN100 is still considered a promising option for preventing S. aureus pneumonia in ventilated patients?
2Since this was a Phase 2 trial testing a single IV dose of ASN100, what do we actually know so far about how safe and effective it is, and is there enough data from this study to guide any decisions about my care?
3Given that this trial focused specifically on patients who were heavily colonized with S. aureus and on a ventilator, is my situation similar enough that the findings — whatever was collected before termination — would even be relevant to my case?
4Are there other active trials or standard treatments for preventing S. aureus pneumonia in ventilated patients that might be a better path forward now that this study has been terminated?
5Because the trial was terminated, is there any way to access ASN100 through a compassionate use or expanded access program, or is that not something worth pursuing given the incomplete data?
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
Efficacy of a Single Intravenous (IV) Dose of ASN100
Timeframe: Incidence of S. aureus pneumonia up to but not including Day 22