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Trial record 1 of 1 for:    ASN100
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Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.

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ClinicalTrials.gov Identifier: NCT02940626
Recruitment Status : Terminated (As a result of a pre-planned interim analysis for futility)
First Posted : October 21, 2016
Results First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Arsanis, Inc.

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.

Condition or disease Intervention/treatment Phase
Pneumonia, Ventilator-associated Pneumonia, Staphylococcal Drug: ASN100 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 2016
Actual Primary Completion Date : July 19, 2018
Actual Study Completion Date : September 28, 2018


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo administered as 2 separate intravenous (IV) infusions
Drug: Placebo
Placebo

Experimental: ASN100
ASN100 administered as 2 separate intravenous (IV) infusions
Drug: ASN100
monoclonal antibody combination of ASN-1 and ASN-2
Other Name: ASN-1 and ASN-2




Primary Outcome Measures :
  1. Efficacy of a Single Intravenous (IV) Dose of ASN100 [ Time Frame: Incidence of S. aureus pneumonia up to but not including Day 22 ]
    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 :
  1. Duration of Mechanical Ventilation [ Time Frame: 21 days ]
    Duration of mechanical ventilation during the first 21 days post-randomization for subjects in the Modified Intent-to-Treat (MITT) Population

  2. Length of ICU Stay [ Time Frame: 21 days ]
    Total length of ICU stay during the first 21 days post-randomization for subjects in the MITT Population

  3. 28-day All-cause Mortality [ Time Frame: 28 days ]
    28-day all-cause mortality in the MITT Population

  4. ASN-1 and ASN-2 Maximum Serum Concentration (Cmax) [ Time Frame: through day 90 ]
    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.

  5. ASN-1 and ASN-2 Time to Maximum Concentration (Tmax) in Serum [ Time Frame: through day 90 ]
    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

  6. ASN-1 and ASN-2 Area Under the Concentration-time Curve in Serum [ Time Frame: through day 90 ]
    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

  7. ASN-1 and ASN-2 Terminal Elimination Half-life (t1/2) in Serum [ Time Frame: through day 90 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940626


Locations
Show Show 93 study locations
Sponsors and Collaborators
Arsanis, Inc.
Investigators
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Study Director: Arsanis, Inc Arsanis, Inc.
  Study Documents (Full-Text)

Documents provided by Arsanis, Inc.:
Statistical Analysis Plan: SAP Addendum  [PDF] October 25, 2018

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Responsible Party: Arsanis, Inc.
ClinicalTrials.gov Identifier: NCT02940626    
Other Study ID Numbers: ASN100-201
2016-002146-23 ( EudraCT Number )
First Posted: October 21, 2016    Key Record Dates
Results First Posted: July 31, 2019
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arsanis, Inc.:
Pneumonia
S. aureus
Mechanically ventilated
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia, Staphylococcal
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial