Back to resultsPrevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.
Primary Purpose
Pneumonia, Ventilator-associated, Pneumonia, Staphylococcal
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ASN100
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pneumonia, Ventilator-associated focused on measuring Pneumonia, S. aureus, Mechanically ventilated
Eligibility Criteria
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.
Sites / Locations
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- Research Site 040-001
- Research Site 040-002
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- Research Site 268-007
- Research Site 268-005
- Research Site 268-009
- Research Site 268-004
- Research Site 268-006
- Research Site 268-002
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- Research Site 268-011
- Research Site 268-003
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- Research Site 268-001
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- Research Site 688-001
- Research Site 688-002
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- Research Site 688-004
- Research Site 688-003
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Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
ASN100
Arm Description
Placebo administered as 2 separate intravenous (IV) infusions
ASN100 administered as 2 separate intravenous (IV) infusions
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Length of ICU Stay
Total length of ICU stay during the first 21 days post-randomization for subjects in the MITT Population
28-day All-cause Mortality
28-day all-cause mortality in the MITT Population
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.
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02940626
Brief Title
Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Single Dose of ASN100 for the Prevention of Staphylococcus Aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
As a result of a pre-planned interim analysis for futility
Study Start Date
November 2016 (Actual)
Primary Completion Date
July 19, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arsanis, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Ventilator-associated, Pneumonia, Staphylococcal
Keywords
Pneumonia, S. aureus, Mechanically ventilated
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered as 2 separate intravenous (IV) infusions
Arm Title
ASN100
Arm Type
Experimental
Arm Description
ASN100 administered as 2 separate intravenous (IV) infusions
Intervention Type
Drug
Intervention Name(s)
ASN100
Other Intervention Name(s)
ASN-1 and ASN-2
Intervention Description
monoclonal antibody combination of ASN-1 and ASN-2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Efficacy of a Single Intravenous (IV) Dose of ASN100
Description
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.
Time Frame
Incidence of S. aureus pneumonia up to but not including Day 22
Secondary Outcome Measure Information:
Title
Duration of Mechanical Ventilation
Description
Duration of mechanical ventilation during the first 21 days post-randomization for subjects in the Modified Intent-to-Treat (MITT) Population
Time Frame
21 days
Title
Length of ICU Stay
Description
Total length of ICU stay during the first 21 days post-randomization for subjects in the MITT Population
Time Frame
21 days
Title
28-day All-cause Mortality
Description
28-day all-cause mortality in the MITT Population
Time Frame
28 days
Title
ASN-1 and ASN-2 Maximum Serum Concentration (Cmax)
Description
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.
Time Frame
through day 90
Title
ASN-1 and ASN-2 Time to Maximum Concentration (Tmax) in Serum
Description
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
Time Frame
through day 90
Title
ASN-1 and ASN-2 Area Under the Concentration-time Curve in Serum
Description
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
Time Frame
through day 90
Title
ASN-1 and ASN-2 Terminal Elimination Half-life (t1/2) in Serum
Description
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
Time Frame
through day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arsanis, Inc
Organizational Affiliation
Arsanis, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Research Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Research Site
City
Georgetown
State/Province
Kentucky
ZIP/Postal Code
40324
Country
United States
Facility Name
Research Site
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Research Site
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37408
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Research Site 040-001
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site 040-002
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Research Site
City
Praha 6
ZIP/Postal Code
169 02
Country
Czechia
Facility Name
Research Site
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Research Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Research Site
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Research Site 268-007
City
Rustavi
ZIP/Postal Code
3700
Country
Georgia
Facility Name
Research Site 268-005
City
Tbilisi
ZIP/Postal Code
114
Country
Georgia
Facility Name
Research Site 268-009
City
Tbilisi
ZIP/Postal Code
141
Country
Georgia
Facility Name
Research Site 268-004
City
Tbilisi
ZIP/Postal Code
144
Country
Georgia
Facility Name
Research Site 268-006
City
Tbilisi
ZIP/Postal Code
144
Country
Georgia
Facility Name
Research Site 268-002
City
Tbilisi
ZIP/Postal Code
159
Country
Georgia
Facility Name
Research Site 268-008
City
Tbilisi
ZIP/Postal Code
159
Country
Georgia
Facility Name
Research Site 268-011
City
Tbilisi
ZIP/Postal Code
159
Country
Georgia
Facility Name
Research Site 268-003
City
Tbilisi
ZIP/Postal Code
160
Country
Georgia
Facility Name
Research Site 268-010
City
Tbilisi
ZIP/Postal Code
163
Country
Georgia
Facility Name
Research Site 268-001
City
Tbilisi
ZIP/Postal Code
191
Country
Georgia
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
H-1134
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
H-1135
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Research Site
City
Ózd
ZIP/Postal Code
3600
Country
Hungary
Facility Name
Research Site
City
Bangalore
ZIP/Postal Code
560002
Country
India
Facility Name
Research Site
City
Hyderabad
ZIP/Postal Code
500096
Country
India
Facility Name
Research Site
City
Jaipur
ZIP/Postal Code
302016
Country
India
Facility Name
Research Site
City
Mahara
ZIP/Postal Code
440003
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400008
Country
India
Facility Name
Research Site
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Research Site
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Research Site
City
H̱olon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Research Site
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-950
Country
Poland
Facility Name
Research Site
City
Opole
ZIP/Postal Code
45-418
Country
Poland
Facility Name
Research Site
City
Abrantes
ZIP/Postal Code
2200
Country
Portugal
Facility Name
Research Site
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1500-461
Country
Portugal
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Research Site
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Research Site
City
Viana do Castelo
ZIP/Postal Code
4901-858
Country
Portugal
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
21661
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
22328
Country
Romania
Facility Name
Research Site
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Research Site
City
Timişoara
ZIP/Postal Code
300723
Country
Romania
Facility Name
Research Site
City
Arkhangel'sk
ZIP/Postal Code
163001
Country
Russian Federation
Facility Name
Research Site
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630008
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630075
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
194104
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Research Site
City
Sestroretsk
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Research Site 688-001
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Research Site 688-002
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Research Site 688-005
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Research Site 688-004
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Research Site 688-003
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
84
Country
South Africa
Facility Name
Research Site
City
Soweto
ZIP/Postal Code
1860
Country
South Africa
Facility Name
Research Site
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
28025
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8221
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Research Site
City
Tarragona
ZIP/Postal Code
43005
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Research Site
City
Ivano-Frankivs'k
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
Research Site
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.
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