Pneumonia, Ventilator-associatedPhase 2NCT02940626
Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.
A Phase 2 study testing ASN100 in people with Pneumonia, Ventilator-associated and Pneumonia, Staphylococcal, run by Arsanis, Inc. at 93 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-associated, Pneumonia, Staphylococcal
- What is being tested?
- ASN100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 93 sitesin 16 countries
- Study dates
- Nov 2016to 28 Sep 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
93 sites in 16 countries.
93 sites in 16 countries
United States17 sites
Research Site
Aurora, Colorado, 80045
Research Site
Buffalo, New York, 14215
Research Site
Burlington, Massachusetts, 01805
Research Site
Charlotte, North Carolina, 28207
Research Site
Chattanooga, Tennessee, 37408
Research Site
Chicago, Illinois, 60611
Research Site
Chicago, Illinois, 60612
Research Site
Cleveland, Ohio, 44106
Research Site
Dallas, Texas, 75390
Research Site
Georgetown, Kentucky, 40324
Research Site
Hazard, Kentucky, 41701
Research Site
Memphis, Tennessee, 38163
Research Site
Phoenix, Arizona, 85006
Research Site
Pittsburgh, Pennsylvania, 15240
Research Site
Sacramento, California, 95817
Research Site
San Francisco, California, 94110
Research Site
St Louis, Missouri, 63110
Georgia11 sites
Research Site 268-007
Rustavi, 3700
Research Site 268-005
Tbilisi, 114
Research Site 268-009
Tbilisi, 141
Research Site 268-004
Tbilisi, 144
Research Site 268-006
Tbilisi, 144
Research Site 268-002
Tbilisi, 159
Research Site 268-008
Tbilisi, 159
Research Site 268-011
Tbilisi, 159
Research Site 268-003
Tbilisi, 160
Research Site 268-010
Tbilisi, 163
Research Site 268-001
Tbilisi, 191
Russia10 sites
Research Site
Arkhangelsk, 163001
Research Site
Barnaul, 656045
Research Site
Moscow, 117997
Research Site
Novosibirsk, 630008
Research Site
Novosibirsk, 630047
Research Site
Novosibirsk, 630075
Research Site
Saint Petersburg, 192242
Research Site
Saint Petersburg, 194104
Research Site
Saint Petersburg, 196247
Research Site
Sestroretsk, 197706
Spain10 sites
Research Site
Badalona, 8916
Research Site
Barcelona, 28025
Research Site
Barcelona, 8035
Research Site
Barcelona, 8036
Research Site
Barcelona, 8221
Research Site
Barcelona, 8907
Research Site
Madrid, 28040
Research Site
Seville, 41013
Research Site
Tarragona, 43005
Research Site
Valencia, 46026
India6 sites
Research Site
Bangalore, 560002
Research Site
Hyderabad, 500096
Research Site
Jaipur, 302016
Research Site
Mahara, 440003
Research Site
Mumbai, 400008
Research Site
Pune, 411001
Portugal6 sites
Research Site
Abrantes, 2200
Research Site
Amadora, 2720-276
Research Site
Lisbon, 1500-461
Research Site
Lisbon, 1649-035
Research Site
Loures, 2674-514
Research Site
Viana do Castelo, 4901-858
Serbia5 sites
Research Site 688-001
Belgrade, 11000
Research Site 688-002
Belgrade, 11000
Research Site 688-005
Belgrade, 11000
Research Site 688-004
Kragujevac, 34000
Research Site 688-003
Niš, 18000
Hungary4 sites
Research Site
Budapest, H-1134
Research Site
Budapest, H-1135
Research Site
Debrecen, H-4032
Research Site
Ózd, 3600
Israel4 sites
Research Site
Hadera, 38100
Research Site
Holon, 5822012
Research Site
Ramat Gan, 5265601
Research Site
Tel Aviv, 6423906
Romania4 sites
Research Site
Bucharest, 21661
Research Site
Bucharest, 22328
Research Site
Craiova, 200642
Research Site
Timișoara, 300723
Ukraine4 sites
Research Site
Dnipro, 49005
Research Site
Ivano-Frankivsk, 76008
Research Site
Kharkiv, 61176
Research Site
Lviv, 79010
France3 sites
Research Site
Argenteuil, 95107
Research Site
Lille, 59037
Research Site
Limoges, 87042
Poland3 sites
Research Site
Bialystok, 15-027
Research Site
Bialystok, 15-950
Research Site
Opole, 45-418
Austria2 sites
Research Site 040-001
Vienna, 1090
Research Site 040-002
Vienna, 1090
About this study
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
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.
Read the 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.
- Being tested
- ASN100, Placebo
- Keywords
- Pneumonia, S. aureus, Mechanically ventilated
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia, Staphylococcal, Pneumonia, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASN100Drug
Also called ASN-1 and ASN-2
monoclonal antibody combination of ASN-1 and ASN-2
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo administered as 2 separate intravenous (IV) infusions Receives: Drug: Placebo |
| ASN100 | Experimental | ASN100 administered as 2 separate intravenous (IV) infusions Receives: Drug: ASN100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Incidence of S. aureus pneumonia up to but not including Day 22
Secondary outcomes (7)
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
Measured: 21 days
Length of ICU Stay
Total length of ICU stay during the first 21 days post-randomization for subjects in the MITT Population
Measured: 21 days
28-day All-cause Mortality
28-day all-cause mortality in the MITT Population
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: through day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion19 Jul 2018
- Study completion28 Sep 2018
Why it stopped: As a result of a pre-planned interim analysis for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumonia, Ventilator-associatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arsanis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arsanis, Inc, Study director, Arsanis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940626
- Sponsor's protocol ID
- ASN100-201
- Other IDs
- 2016-002146-23, 2016
- Status last verified
- Jul 2019
- First submitted
- 17 Oct 2016
- Last updated
- 31 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02940626
- Acronym / sponsor ID
- ASN100-201
- Keywords
- Pneumonia, S. aureus, Mechanically ventilated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As a result of a pre-planned interim analysis for futility
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Arsanis, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Posted 31 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered as 2 separate intravenous (IV) infusions |
| ASN100 | Experimental | Drug: ASN100ASN100 administered as 2 separate intravenous (IV) infusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASN100Also: ASN-1 and ASN-2monoclonal antibody combination of ASN-1 and ASN-2 | Drug | ASN100 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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.
7 secondary outcomes
Duration of Mechanical Ventilation
Time frame: 21 days
Length of ICU Stay
Time frame: 21 days
28-day All-cause Mortality
Time frame: 28 days
ASN-1 and ASN-2 Maximum Serum Concentration (Cmax)
Time frame: through day 90
ASN-1 and ASN-2 Time to Maximum Concentration (Tmax) in Serum
Time frame: through day 90
ASN-1 and ASN-2 Area Under the Concentration-time Curve in Serum
Time frame: through day 90
ASN-1 and ASN-2 Terminal Elimination Half-life (t1/2) in Serum
Time frame: through day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
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Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arsanis, Inc study director
Arsanis, Inc.
93 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASN100 in people with Pneumonia, Ventilator-associated and Pneumonia, Staphylococcal, run by Arsanis, Inc. at 93 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, Georgia, Russia, Spain, India and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of a Single Intravenous (IV) Dose of ASN100 (time frame: Incidence of S. aureus pneumonia up to but not including Day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.