Clinical trial NCT02940626: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pneumonia, Ventilator-associated
Pneumonia, Staphylococcal
Keywords: Pneumonia
S. aureus
Mechanically ventilated
Lead sponsor: Arsanis, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-21
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Efficacy of a Single Intravenous (IV) Dose of ASN100
timeFrame: Incidence of S. aureus pneumonia up to but not including Day 22
Secondary outcomes:
measure: Duration of Mechanical Ventilation
timeFrame: 21 days
measure: Length of ICU Stay
timeFrame: 21 days
measure: 28-day All-cause Mortality
timeFrame: 28 days
measure: ASN-1 and ASN-2 Maximum Serum Concentration (Cmax)
timeFrame: through day 90
measure: ASN-1 and ASN-2 Time to Maximum Concentration (Tmax) in Serum
timeFrame: through day 90
measure: ASN-1 and ASN-2 Area Under the Concentration-time Curve in Serum
timeFrame: through day 90
measure: ASN-1 and ASN-2 Terminal Elimination Half-life (t1/2) in Serum
timeFrame: through day 90
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Georgetown
country: United States
facility: Research Site
state: Kentucky
city: Hazard
country: United States
facility: Research Site
state: Kentucky
city: Burlington
country: United States
facility: Research Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Wien
country: Austria
facility: Research Site 040-001
city: Wien
country: Austria
facility: Research Site 040-002
city: Praha 10
country: Czechia
facility: Research Site
city: Praha 6
country: Czechia
facility: Research Site
city: Argenteuil
country: France
facility: Research Site
city: Lille Cedex
country: France
facility: Research Site
city: Limoges
country: France
facility: Research Site
city: Rustavi
country: Georgia
facility: Research Site 268-007
city: Tbilisi
country: Georgia
facility: Research Site 268-005
city: Tbilisi
country: Georgia
facility: Research Site 268-009
city: Tbilisi
country: Georgia
facility: Research Site 268-004
city: Tbilisi
country: Georgia
facility: Research Site 268-006
city: Tbilisi
country: Georgia
facility: Research Site 268-002
city: Tbilisi
country: Georgia
facility: Research Site 268-008
city: Tbilisi
country: Georgia
facility: Research Site 268-011
city: Tbilisi
country: Georgia
facility: Research Site 268-003
city: Tbilisi
country: Georgia
facility: Research Site 268-010
city: Tbilisi
country: Georgia
facility: Research Site 268-001
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Ózd
country: Hungary
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Jaipur
country: India
facility: Research Site
city: Mahara
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Hadera
country: Israel
facility: Research Site
city: H̱olon
country: Israel
facility: Research Site
city: Ramat Gan
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Opole
country: Poland
facility: Research Site
city: Abrantes
country: Portugal
facility: Research Site
city: Amadora
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Loures
country: Portugal
facility: Research Site
city: Viana do Castelo
country: Portugal
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Timişoara
country: Romania
facility: Research Site
city: Arkhangel'sk
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Sestroretsk
country: Russian Federation
facility: Research Site
city: Belgrad
country: Serbia
facility: Research Site 688-001
city: Belgrad
country: Serbia
facility: Research Site 688-002
city: Belgrad
country: Serbia
facility: Research Site 688-005
city: Kragujevac
country: Serbia
facility: Research Site 688-004
city: Niš
country: Serbia
facility: Research Site 688-003
city: Pretoria
country: South Africa
facility: Research Site
city: Soweto
country: South Africa
facility: Research Site
city: Badalona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Tarragona
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Dnipro
country: Ukraine
facility: Research Site
city: Ivano-Frankivs'k
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
Study officials:
affiliation: Arsanis, Inc.
name: Arsanis, Inc
role: STUDY_DIRECTOR
References: