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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002146-23 | EudraCT Number |
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As a result of a pre-planned interim analysis for futility
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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.
This is a double-blind, randomized, single-dose, placebo-controlled study of ASN100 for the prevention of S. aureus pneumonia in mechanically ventilated subjects who are heavily colonized with S. aureus. This will be a global study conducted at approximately 65 sites to assess the safety, tolerability, and efficacy of ASN100.
Eligible subjects who meet all of the inclusion criteria and none of the exclusion criteria will be screened by semi-quantitative culture of an endotracheal aspirate (ETA) to identify those who are heavily colonized with S. aureus (3+ to 4+). Upon determination of eligibility, subjects will be randomized in a 1:1 ratio to 1 of 2 treatment groups, ASN100 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo administered as 2 separate intravenous (IV) infusions |
|
| ASN100 | Experimental | ASN100 administered as 2 separate intravenous (IV) infusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASN100 | Drug | monoclonal antibody combination of ASN-1 and ASN-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of a Single Intravenous (IV) Dose of ASN100 | Percentage of subjects in the MITT population who have or have not developed S. aureus (SA) pneumonia after a single intravenous (IV) dose of ASN100, based on sponsor defined outcome (SDO1). For each arm, the empirical proportion is defined by a ratio, which is the number of SA pneumonia events divided by the total number of subjects in the arm. The inference about the difference of two population rates is based on the empirical counterpart; specifically, the point estimate, 95% confidence interval and p-value for the rate difference. Subjects discontinued from the study due to any cause prior to Day 22 were considered as not developing SA pneumonia for the primary efficacy analysis. | Incidence of S. aureus pneumonia up to but not including Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Mechanical Ventilation | Duration of mechanical ventilation during the first 21 days post-randomization for subjects in the Modified Intent-to-Treat (MITT) Population | 21 days |
| Length of ICU Stay |
Not provided
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:
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| Name | Affiliation | Role |
|---|---|---|
| Arsanis, Inc | Arsanis, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85006 | United States | ||
| Research Site |
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Eligible subjects underwent daily screening of endotracheal aspirates to determine if they met randomization criteria. Only subjects who were randomized are included in the study analysis and summarized in the Participant Flow. A single subject was randomized/treated in a site-specific pneumonia treatment sub-study.
Subjects were randomized at 35 centers in the United States, Austria, Czechia, France, India, Israel, Poland, Portugal, Romania, Serbia, Spain, Rep. of Georgia, and Russian Federation
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| ID | Title | Description |
|---|---|---|
| FG000 | ASN100 | ASN100 administered as 2 separate intravenous (IV) infusions ASN100 3600 mg: monoclonal antibody combination of ASN-1(1800 mg) and ASN-2(1800 mg) [administered once] |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Primary VAP Prevention Study | May 2, 2017 |
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| Placebo | Drug | Placebo |
|
Total length of ICU stay during the first 21 days post-randomization for subjects in the MITT Population
| 21 days |
| 28-day All-cause Mortality | 28-day all-cause mortality in the MITT Population | 28 days |
| ASN-1 and ASN-2 Maximum Serum Concentration (Cmax) | The levels of ASN-1 and ASN-2 measured at completion of study medication infusion, and at 6 hr, 24 hr, Day 4, Day 7, Day 14, Day 22, and Day 90 (final study visit) in subjects who are hospitalized or are able to return to the clinic for blood sampling. | through day 90 |
| ASN-1 and ASN-2 Time to Maximum Concentration (Tmax) in Serum | The levels of ASN-1 and ASN-2 measured at completion of study medication infusion, and at 6 hr, 24 hr, Day 4, Day 7, Day 14, Day 22, and Day 90 after completion | through day 90 |
| ASN-1 and ASN-2 Area Under the Concentration-time Curve in Serum | The levels of ASN-1 and ASN-2 measured at completion of study medication infusion, and at 6 hr, 24 hr, Day 4, Day 7, Day 14, Day 22, and Day 90 after completion | through day 90 |
| ASN-1 and ASN-2 Terminal Elimination Half-life (t1/2) in Serum | The levels of ASN-1 and ASN-2 measured at completion of study medication infusion, and at 6 hr, 24 hr, Day 4, Day 7, Day 14, Day 22, and Day 90 after completion | through day 90 |
| Sacramento |
| California |
| 95817 |
| United States |
| Research Site | San Francisco | California | 94110 | United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Chicago | Illinois | 60611 | United States |
| Research Site | Chicago | Illinois | 60612 | United States |
| Research Site | Georgetown | Kentucky | 40324 | United States |
| Research Site | Hazard | Kentucky | 41701 | United States |
| Research Site | Burlington | Massachusetts | 01805 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Buffalo | New York | 14215 | United States |
| Research Site | Charlotte | North Carolina | 28207 | United States |
| Research Site | Cleveland | Ohio | 44106 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15240 | United States |
| Research Site | Chattanooga | Tennessee | 37408 | United States |
| Research Site | Memphis | Tennessee | 38163 | United States |
| Research Site | Dallas | Texas | 75390 | United States |
| Research Site 040-001 | Vienna | 1090 | Austria |
| Research Site 040-002 | Vienna | 1090 | Austria |
| Research Site | Prague | 100 34 | Czechia |
| Research Site | Prague | 169 02 | Czechia |
| Research Site | Argenteuil | 95107 | France |
| Research Site | Lille | 59037 | France |
| Research Site | Limoges | 87042 | France |
| Research Site 268-007 | Rustavi | 3700 | Georgia |
| Research Site 268-005 | Tbilisi | 114 | Georgia |
| Research Site 268-009 | Tbilisi | 141 | Georgia |
| Research Site 268-004 | Tbilisi | 144 | Georgia |
| Research Site 268-006 | Tbilisi | 144 | Georgia |
| Research Site 268-002 | Tbilisi | 159 | Georgia |
| Research Site 268-008 | Tbilisi | 159 | Georgia |
| Research Site 268-011 | Tbilisi | 159 | Georgia |
| Research Site 268-003 | Tbilisi | 160 | Georgia |
| Research Site 268-010 | Tbilisi | 163 | Georgia |
| Research Site 268-001 | Tbilisi | 191 | Georgia |
| Research Site | Budapest | H-1134 | Hungary |
| Research Site | Budapest | H-1135 | Hungary |
| Research Site | Debrecen | H-4032 | Hungary |
| Research Site | Ózd | 3600 | Hungary |
| Research Site | Bangalore | 560002 | India |
| Research Site | Hyderabad | 500096 | India |
| Research Site | Jaipur | 302016 | India |
| Research Site | Mahara | 440003 | India |
| Research Site | Mumbai | 400008 | India |
| Research Site | Pune | 411001 | India |
| Research Site | Hadera | 38100 | Israel |
| Research Site | Holon | 5822012 | Israel |
| Research Site | Ramat Gan | 5265601 | Israel |
| Research Site | Tel Aviv | 6423906 | Israel |
| Research Site | Bialystok | 15-027 | Poland |
| Research Site | Bialystok | 15-950 | Poland |
| Research Site | Opole | 45-418 | Poland |
| Research Site | Abrantes | 2200 | Portugal |
| Research Site | Amadora | 2720-276 | Portugal |
| Research Site | Lisbon | 1500-461 | Portugal |
| Research Site | Lisbon | 1649-035 | Portugal |
| Research Site | Loures | 2674-514 | Portugal |
| Research Site | Viana do Castelo | 4901-858 | Portugal |
| Research Site | Bucharest | 21661 | Romania |
| Research Site | Bucharest | 22328 | Romania |
| Research Site | Craiova | 200642 | Romania |
| Research Site | Timișoara | 300723 | Romania |
| Research Site | Arkhangelsk | 163001 | Russia |
| Research Site | Barnaul | 656045 | Russia |
| Research Site | Moscow | 117997 | Russia |
| Research Site | Novosibirsk | 630008 | Russia |
| Research Site | Novosibirsk | 630047 | Russia |
| Research Site | Novosibirsk | 630075 | Russia |
| Research Site | Saint Petersburg | 192242 | Russia |
| Research Site | Saint Petersburg | 194104 | Russia |
| Research Site | Saint Petersburg | 196247 | Russia |
| Research Site | Sestroretsk | 197706 | Russia |
| Research Site 688-001 | Belgrade | 11000 | Serbia |
| Research Site 688-002 | Belgrade | 11000 | Serbia |
| Research Site 688-005 | Belgrade | 11000 | Serbia |
| Research Site 688-004 | Kragujevac | 34000 | Serbia |
| Research Site 688-003 | Niš | 18000 | Serbia |
| Research Site | Pretoria | 84 | South Africa |
| Research Site | Soweto | 1860 | South Africa |
| Research Site | Badalona | 8916 | Spain |
| Research Site | Barcelona | 28025 | Spain |
| Research Site | Barcelona | 8035 | Spain |
| Research Site | Barcelona | 8036 | Spain |
| Research Site | Barcelona | 8221 | Spain |
| Research Site | Barcelona | 8907 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Seville | 41013 | Spain |
| Research Site | Tarragona | 43005 | Spain |
| Research Site | Valencia | 46026 | Spain |
| Research Site | Dnipro | 49005 | Ukraine |
| Research Site | Ivano-Frankivsk | 76008 | Ukraine |
| Research Site | Kharkiv | 61176 | Ukraine |
| Research Site | Lviv | 79010 | Ukraine |
Placebo administered as 2 separate intravenous (IV) infusions
Placebo: Placebo [administered once]
|
| Randomized Into Primary Prevention Study |
|
| Randomized Into Treatment Sub-study | Single subject randomized/treated (placebo) in pneumonia treatment sub-study before trial terminated |
|
| Received Study Treatment | Of the 77 subjects in the placebo arm, 76 were in primary prevention study, 1 in treatment sub-study |
|
| Completed Through Study Day 22 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Population = Modified Intent to Treat (MITT), the population analyzed for determination of the primary endpoint. MITT includes subjects in the ITT Population who receive study drug AND who are heavily colonized with S. aureus as determined by quantitative or semi-quantitative culture of an ETA specimen prior to randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | ASN100 | ASN100 administered as 2 separate intravenous (IV) infusions ASN100 3600 mg: monoclonal antibody combination of ASN-1(1800 mg) and ASN-2(1800 mg) [administered once] |
| BG001 | Placebo | Placebo administered as 2 separate intravenous (IV) infusions Placebo: Placebo [administered once] |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Body Mass Index Category | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of a Single Intravenous (IV) Dose of ASN100 | Percentage of subjects in the MITT population who have or have not developed S. aureus (SA) pneumonia after a single intravenous (IV) dose of ASN100, based on sponsor defined outcome (SDO1). For each arm, the empirical proportion is defined by a ratio, which is the number of SA pneumonia events divided by the total number of subjects in the arm. The inference about the difference of two population rates is based on the empirical counterpart; specifically, the point estimate, 95% confidence interval and p-value for the rate difference. Subjects discontinued from the study due to any cause prior to Day 22 were considered as not developing SA pneumonia for the primary efficacy analysis. | MITT: There are 2 SDO definitions. SDO1 meets either respiratory OR signs/symptoms requirements while SDO2 must meet BOTH. Individual assessments for each randomized subject were collapsed to assign a SDO1/SDO2 of Yes, No, Indeterminate (insufficient data to assign a SDO of Yes or No), or Censored (subject died prior to the Day 22 assessment). | Posted | Count of Participants | Participants | Incidence of S. aureus pneumonia up to but not including Day 22 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Mechanical Ventilation | Duration of mechanical ventilation during the first 21 days post-randomization for subjects in the Modified Intent-to-Treat (MITT) Population | Modified Intent to Treat (MITT): Includes All subjects in ITT Population (randomized) who received study drug and were heavily colonized with S. aureus determined by quantitative or semi-quant. culture of an ETA specimen. Exclusion from the MITT was determined programmatically. Subjects on MV < 2 days post treatment were excluded from analysis. | Posted | Mean | Standard Deviation | Days | 21 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of ICU Stay | Total length of ICU stay during the first 21 days post-randomization for subjects in the MITT Population | Modified Intent to Treat (MITT): Includes all subjects in ITT Population (randomized) who received study drug and were heavily colonized with S. aureus determined by quantitative/semi-quant. culture of an ETA specimen. Exclusion from the MITT determined programmatically. Subjects not listed as being in ICU post treatment were excluded from analysis | Posted | Mean | Standard Deviation | Days | 21 days |
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| Secondary | 28-day All-cause Mortality | 28-day all-cause mortality in the MITT Population | Modified Intent to treat (MITT): includes all subjects in the ITT Population (randomized subjects) who receive study drug and who are heavily colonized with S. aureus as determined by quantitative or semi-quantitative culture of an ETA specimen. Exclusion from the MITT Population was determined programmatically for each ITT subject. | Posted | Count of Participants | Participants | 28 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ASN-1 and ASN-2 Maximum Serum Concentration (Cmax) | The levels of ASN-1 and ASN-2 measured at completion of study medication infusion, and at 6 hr, 24 hr, Day 4, Day 7, Day 14, Day 22, and Day 90 (final study visit) in subjects who are hospitalized or are able to return to the clinic for blood sampling. | Pharmacokinetic (PK) Population: All subjects in the MITT population with at least 1 serum PK sample collected post-dose. Of the 76 subjects who received ASN100, 74 were included in the PK analysis as a result of 2 not having sufficient data. Additional reductions in the number of participants analyzed is due to missing or out of window samples. | Posted | Mean | Standard Deviation | μg/mL | through day 90 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ASN-1 and ASN-2 Time to Maximum Concentration (Tmax) in Serum | The levels of ASN-1 and ASN-2 measured at completion of study medication infusion, and at 6 hr, 24 hr, Day 4, Day 7, Day 14, Day 22, and Day 90 after completion | Pharmacokinetic (PK) Population: All subjects in the MITT population with at least 1 serum PK sample collected post-dose. Of the 76 subjects who received ASN100, 74 were included in the PK analysis as a result of 2 not having sufficient data. Additional reductions in the number of participants analyzed is due to missing or out of window samples. | Posted | Mean | Standard Deviation | Hours (from end of infusion) | through day 90 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ASN-1 and ASN-2 Area Under the Concentration-time Curve in Serum | The levels of ASN-1 and ASN-2 measured at completion of study medication infusion, and at 6 hr, 24 hr, Day 4, Day 7, Day 14, Day 22, and Day 90 after completion | Pharmacokinetic (PK) Population: All subjects in the MITT population with at least 1 serum PK sample collected post-dose. Of the 76 subjects who received ASN100, 74 were included in the PK analysis as a result of 2 not having sufficient data. Additional reductions in the number of participants analyzed is due to missing or out of window samples. | Posted | Mean | Standard Deviation | μg*h/mL | through day 90 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ASN-1 and ASN-2 Terminal Elimination Half-life (t1/2) in Serum | The levels of ASN-1 and ASN-2 measured at completion of study medication infusion, and at 6 hr, 24 hr, Day 4, Day 7, Day 14, Day 22, and Day 90 after completion | Pharmacokinetic (PK) Population: All subjects in the MITT population with at least 1 serum PK sample collected post-dose. Of the 76 subjects who received ASN100, 74 were included in the PK analysis as a result of 2 not having sufficient data. Additional reductions in the number of participants analyzed is due to missing or out of window samples. | Posted | Mean | Standard Deviation | Hours | through day 90 |
|
|
3 months
Adverse events (AEs) analyzed include treatment-emergent AEs, from the time of randomization through the Day 90 study visit (i.e. last study visit). Only study procedure related AEs were to be reported from the time that informed consent was signed up to randomization, if they were considered to be study procedure related, however no such AEs were reported. Therefore, study procedure related AEs prior to randomization were not analyzed or reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ASN100 | ASN100 administered as 2 separate intravenous (IV) infusions ASN100: monoclonal antibody combination of ASN-1 and ASN-2 | 41 | 77 | 49 | 77 | 74 | 77 |
| EG001 | Placebo | Placebo administered as 2 separate intravenous (IV) infusions Placebo: Placebo | 32 | 77 | 38 | 77 | 69 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac Failture Acute | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ventricular Fibrillation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiovascular Insufficiency | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ventricular Asytole | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac Disorder | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cardiopulmonary Failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Left ventricular Failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pericardial Haemorrhage | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ventricular Rupture | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment | Pneumonia, which was an endpoint for the trial, was only entered as an Adverse Event (AE) if it met serious reporting criteria (i.e. SAE) |
|
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Meningitis Bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Splenic Abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Brain Herniation | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Craniocerebral Injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Spinal Shock | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neoplasm Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Cerebral Congestion | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Brain Oedema | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ischemia Stroke | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemorrhagic Transformation Stroke | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nervous System Disorder | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cerebrospinal Fluid Circulation Disorder | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Guillain-Barre Syndrome | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Toxic Encephalopathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tracheal Stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Deep vein Thrombosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Neurogenic Shock | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral Artery Thrombosis | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Tracheo-oesophageal Fistula | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis Bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Acute Kidney injury | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
An interim analysis of 118 subjects was performed by a DRC to assess S. aureus pneumonia rates and the conditional power to detect a statistically significant treatment effect at study completion (354 subjects). The study was terminated for futility.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Operations | X4 Pharmaceuticals (merged with Arsanis) | (857) 529-8300 | rnd@x4pharma.com |
| Jun 19, 2019 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Site-specific VAP Treatment Sub-study | Apr 23, 2018 | Jun 19, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: SAP Addendum | Oct 25, 2018 | Jun 19, 2019 | SAP_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Primary Plan | Jun 25, 2018 | Jul 9, 2019 | SAP_003.pdf |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D011023 | Pneumonia, Staphylococcal |
| D011014 | Pneumonia |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D018410 | Pneumonia, Bacterial |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707749 | ASN100 |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Czechia |
|
| Portugal |
|
| India |
|
| Russia |
|
| Spain |
|
| Austria |
|
| Poland |
|
| Georgia |
|
| Israel |
|
| France |
|
| Serbia |
|
| Censored |
|
| Indeterminate |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|