Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.

NCT02940626 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: ASN100-2012016-002146-23
• Study Type: interventional
• Target: 155
• Locations: 16 countries
• Sites: 93

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.

Conditions

Pneumonia, Ventilator-associated; Pneumonia, Staphylococcal

Keywords

Pneumonia; S. aureus; Mechanically ventilated

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Duration of Mechanical Ventilation

  21 days

• Length of ICU Stay

  21 days

• 28-day All-cause Mortality

  28 days

• ASN-1 and ASN-2 Maximum Serum Concentration (Cmax)

  through day 90

• ASN-1 and ASN-2 Time to Maximum Concentration (Tmax) in Serum

  through day 90

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo administered as 2 separate intravenous (IV) infusions

Drug: Placebo

ASN100

EXPERIMENTAL

ASN100 administered as 2 separate intravenous (IV) infusions

Drug: ASN100

Interventions

ASN100 DRUG

monoclonal antibody combination of ASN-1 and ASN-2

Also known as: ASN-1 and ASN-2

ASN100

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arsanis, Inc.: lead

Study Sites (93)

Research Site

Phoenix, Arizona, 85006, United States

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Sacramento, California, 95817, United States

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San Francisco, California, 94110, United States

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Aurora, Colorado, 80045, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60612, United States

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Georgetown, Kentucky, 40324, United States

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Hazard, Kentucky, 41701, United States

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Burlington, Massachusetts, 01805, United States

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St Louis, Missouri, 63110, United States

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Buffalo, New York, 14215, United States

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Charlotte, North Carolina, 28207, United States

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Cleveland, Ohio, 44106, United States

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Pittsburgh, Pennsylvania, 15240, United States

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Chattanooga, Tennessee, 37408, United States

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Memphis, Tennessee, 38163, United States

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Dallas, Texas, 75390, United States

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Vienna, 1090, Austria

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Vienna, 1090, Austria

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Prague, 100 34, Czechia

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Prague, 169 02, Czechia

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Argenteuil, 95107, France

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Lille, 59037, France

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Limoges, 87042, France

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Research Site 268-007

Rustavi, 3700, Georgia

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Research Site 268-005

Tbilisi, 114, Georgia

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Research Site 268-009

Tbilisi, 141, Georgia

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Research Site 268-004

Tbilisi, 144, Georgia

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Research Site 268-006

Tbilisi, 144, Georgia

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Research Site 268-002

Tbilisi, 159, Georgia

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Research Site 268-008

Tbilisi, 159, Georgia

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Research Site 268-011

Tbilisi, 159, Georgia

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Research Site 268-003

Tbilisi, 160, Georgia

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Research Site 268-010

Tbilisi, 163, Georgia

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Research Site 268-001

Tbilisi, 191, Georgia

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Budapest, H-1134, Hungary

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Budapest, H-1135, Hungary

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Debrecen, H-4032, Hungary

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Ózd, 3600, Hungary

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Bangalore, 560002, India

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Hyderabad, 500096, India

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Jaipur, 302016, India

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Mahara, 440003, India

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Mumbai, 400008, India

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Pune, 411001, India

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Hadera, 38100, Israel

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Holon, 5822012, Israel

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Ramat Gan, 5265601, Israel

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Tel Aviv, 6423906, Israel

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Bialystok, 15-027, Poland

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Bialystok, 15-950, Poland

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Opole, 45-418, Poland

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Abrantes, 2200, Portugal

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Amadora, 2720-276, Portugal

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Lisbon, 1500-461, Portugal

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Lisbon, 1649-035, Portugal

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Loures, 2674-514, Portugal

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Viana do Castelo, 4901-858, Portugal

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Bucharest, 21661, Romania

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Bucharest, 22328, Romania

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Craiova, 200642, Romania

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Timișoara, 300723, Romania

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Arkhangelsk, 163001, Russia

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Barnaul, 656045, Russia

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Moscow, 117997, Russia

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Novosibirsk, 630008, Russia

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Novosibirsk, 630047, Russia

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Novosibirsk, 630075, Russia

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Saint Petersburg, 192242, Russia

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Saint Petersburg, 194104, Russia

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Saint Petersburg, 196247, Russia

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Sestroretsk, 197706, Russia

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Research Site 688-001

Belgrade, 11000, Serbia

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Research Site 688-002

Belgrade, 11000, Serbia

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Research Site 688-005

Belgrade, 11000, Serbia

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Research Site 688-004

Kragujevac, 34000, Serbia

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Research Site 688-003

Niš, 18000, Serbia

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Pretoria, 84, South Africa

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Soweto, 1860, South Africa

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Badalona, 8916, Spain

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Barcelona, 28025, Spain

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Barcelona, 8035, Spain

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Barcelona, 8036, Spain

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Barcelona, 8221, Spain

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Barcelona, 8907, Spain

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Madrid, 28040, Spain

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Seville, 41013, Spain

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Tarragona, 43005, Spain

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Valencia, 46026, Spain

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Dnipro, 49005, Ukraine

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Ivano-Frankivsk, 76008, Ukraine

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Kharkiv, 61176, Ukraine

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Lviv, 79010, Ukraine

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MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Pneumonia, Staphylococcal; Pneumonia; Staphylococcal Infections

Interventions

ASN100

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia, Bacterial

Limitations and Caveats

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.

Results Point of Contact

• Title: Vice President, Clinical Operations
• Organization: X4 Pharmaceuticals (merged with Arsanis)

rnd@x4pharma.com

(857) 529-8300

Study Officials

• Arsanis, Inc

  Arsanis, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 21, 2016
• Study Start: November 1, 2016
• Primary Completion: July 19, 2018
• Study Completion: September 28, 2018
• Last Updated: July 31, 2019
• Results First Posted: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); IN (6); ZA (2); FR (3); ES (10); IL (4); CZ (2); PT (6); PL (3); RO (4); US (17); GE (11); RU (10); UA (4); SE (5); HU (4)