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CTRI Number  CTRI/2018/04/013442 [Registered on: 24/04/2018] Trial Registered Prospectively
Last Modified On: 20/07/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus  
Scientific Title of Study   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  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ASN100-201, Ver 4.0 dated 02May2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rudolph Julius D Almeida PhD  
Designation  Project Manager 
Affiliation  Pharm-Olam International (India) Pvt. Ltd 
Address  Pharm-Olam International (India) Pvt. Ltd, No. 15, KMJ Arcadia, 4th Floor, Industrial Main Road, Koramangala, 5th Block, Bangalore, India
NA
Bangalore
KARNATAKA
560 095
India 
Phone  91-80-67182211  
Fax  91-80-41105520  
Email  Rudolph.Julius-Almeida@pharm-olam.com  
 
Details of Contact Person
Scientific Query  
Name  TV Thanuja Naidu 
Designation  Country Head & Manager-Clinical Operations,  
Affiliation  Pharm-Olam International (India) Pvt. Ltd 
Address  Pharm-Olam International (India) Pvt. Ltd, No. 15, KMJ Arcadia, I Floor, Industrial Main Road, Koramangala, 5th Block, Bangalore, India.
NA
Bangalore
KARNATAKA
560 095
India 
Phone  91-80-67182215  
Fax  91-80-41105520  
Email  Thanuja.Naidu@pharm-olam.com  
 
Details of Contact Person
Public Query  
Name  TV Thanuja Naidu 
Designation  Country Head & Manager-Clinical Operations,  
Affiliation  Pharm-Olam International (India) Pvt. Ltd 
Address  Pharm-Olam International (India) Pvt. Ltd, No. 15, KMJ Arcadia, I Floor, Industrial Main Road, Koramangala, 5th Block, Bangalore, India.
NA
Bangalore
KARNATAKA
560 095
India 
Phone  91-80-67182215  
Fax  91-80-41105520  
Email  Thanuja.Naidu@pharm-olam.com  
 
Source of Monetary or Material Support  
Arsanis Inc, 890 Winter Street, Suite 230 Waltham, MA 02451-1472 
 
Primary Sponsor  
Name  Arsanis Inc 
Address  890 Winter Street, Suite 230 Waltham, MA 02451-1472 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Israel
Algeria
Czech Republic
France
Georgia
Germany
Hungary
Poland
Portugal
Romania
Russian Federation
Serbia
Spain
Ukraine
United States of America
South Africa  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sai Praveen Haranath  Apollo Hospitals  Apollo Hospitals, Jubilee Hills, Hyderabad-500096 Telangana, India
Hyderabad
ANDHRA PRADESH 		 9866415551
040-23543270
indialungdoc@gmail.com 
Dr Prachee Sathe  Ruby Hall Clinic  Grant Medical Foundation,dept. of Critical care medicine, 40, Sassoon Road, Pune - 411001 Maharashtra, India
Pune
MAHARASHTRA 		 9960686867
020-66455628
prachee.sathe@gmail.com 
Dr Narendra Khippal  SMS Medical College & Hospital  SMS Medical College & Hospital, Institute of Respiratory Diseases, B2 Subhash Nagar Shopping Center Shastri Nagar, Jaipur, 302016, Rajasthan, India
Jaipur
RAJASTHAN 		 9821695349
02239167449
girishraj63@hotmail.com 
Dr Raveendra K R  Victoria Hospital  Victoria Hospital Room No72/A, 2nd Floor, C Block Bangalore Medical College and Research Institute, Fort Bangalore 560002, Karnataka, India
Bangalore
KARNATAKA 		 9498134587
080-26706260
drkrraveendra@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee of Bangalore Medical College & Research Institute  Approved 
Ethics committee of S M S Medical College & Attached Hospitals  Submittted/Under Review 
Institutional Ethics Committee, Apollo Hospitals (Apollo Health City)  Approved 
Institutional Ethics Committee, Government Medical College and Hospital, Nagpur  Approved 
Institutional Ethics Committee, Poona Medical Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Prevention of Staphylococcus aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IV infusions ofsingle IV dose of 3600 mg of ASN100 (comprised of separate infusions each of 1800 mg ASN-1 and 1800 mg ASN-2)  IV infusions ofsingle IV dose of 3600 mg of ASN100 (comprised of separate infusions each of 1800 mg ASN-1 and 1800 mg ASN-2) 
Comparator Agent  Placebo: administered either sequentially or simultaneously as 2 separate IV infusions  Placebo: administered either sequentially or simultaneously as 2 separate IV infusions 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Subject, legally authorized representative, or council of independent physicians (CIP) (if
applicable) has provided written informed consent;
2. Subject is ≥18 years of age at the time of enrollment;
3. 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;
NOTE: Subjects with a tracheostomy at the time of enrollment are not eligible. After
enrollment, conversion to tracheostomy is permitted per standard of care.
4. Female subjects must not be pregnant or lactating. Female subjects of childbearing potential
must have a documented negative pregnancy test at the Screening Visit. Female subjects may
be enrolled on the basis of a negative urine pregnancy test, pending the result of a negative
serum pregnancy test prior to randomization; and
5. Female subjects of childbearing potential and non-surgically sterile male subjects who are
sexually active must agree to use an approved highly effective form of contraception from the
time of informed consent until 165 days post-dose. Approved forms of contraception include
hormonal intrauterine devices, hormonal contraceptives (oral birth control pill, depo, patch, or
injectable) together with supplementary double barrier methods such as condoms or
diaphragms with spermicidal gel or foam.
NOTE: The following categories define women who are NOT considered to be of childbearing
potential:
• Premenopausal female with 1 of the following:
o Documented hysterectomy,
o Documented bilateral salpingectomy, or
o Documented bilateral oophorectomy, or
• Postmenopausal female, defined as having amenorrhea for at least 12 months without an
alternative medical cause.
 
 
ExclusionCriteria 
Details  1. Subject has received intravenous (IV) immunoglobulin therapy within 4 months prior to the
Screening Visit;
2. Subject has a chest X-ray or thoracic computed tomography (CT) scan that is definitive for a
diagnosis of pneumonia;
3. Subject demonstrates both of the following:
a. Need for acute changes in ventilator support to enhance oxygenation or to the amount of
positive end-expiratory pressure; AND
NOTE: Changes made in ventilator support due to day-to-day maintenance other than
those changes made to improve oxygenation will not exclude a subject from participation
in the study.
b. New onset of purulent suctioned respiratory secretions;
4. 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;
NOTE: Randomization should not be delayed while waiting for Gram-negative results if heavy
colonization with S. aureus has been confirmed.
5. Subject has been diagnosed with neutropenia (absolute neutrophil count <500/mm3);
6. Subject has a severe non-pulmonary source of infection which, in the Investigator’s opinion,
would interfere with the conduct of the study or jeopardize the subject’s safety;
7. Subject is currently on either continuous veno-venous hemodialysis or extracorporeal
membrane oxygenation;
8. Subject has been previously exposed to ASN100 or ASN-1 or ASN-2, individually;
9. Subject has a known hypersensitivity to ASN100 or any of its excipients;
10. Subject has received any investigational product within 30 days prior to the Screening Visit
(or 5 half-lives of the investigational product, whichever is longer);
11. Subject has, in the opinion of the Investigator, a high probability of death within 72 hours of
enrollment;
12. Subject is, in the opinion of the Investigator, not able or willing to comply with the protocol;
13. Any condition that, in the opinion of the Investigator, would compromise the safety of the
subject, the potential activity of the study drug, or the quality of the data; or
14. Subjects with a known history or current (suspected) diagnosis of cytokine release syndrome
associated with the administration of peptides, proteins, and/or antibodies.20
NOTE: Subjects with a prior history of sepsis are not excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of subjects in MITT population who develop S. aureus pneumonia   Up to day 22 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of mechanical ventilation  21 day 
Length of ICU stay  21 days 
All cause mortality  28 days  
 
Target Sample Size   Total Sample Size="354"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   04/05/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/11/2016 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="7"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Other (Terminated) 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   Rouha H, Weber S, Maierhofer B, Janesch P, Gross K, Kabak E, Dolezilkova I, Mirkina I, Visram ZC, Malafa S, Stulik L, Magyarics Z, Badarau A, Nagy E. Disarming Staphylococcus aureus from destroying human cells by simultaneously inactivating six cytotoxins with two human monoclonal antibodies. Virulence ePub 3-Nov-2017. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 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 70 sites. Subjects will be screened for eligibility; once an Informed Consent Form (ICF) is signed and all entry criteria are met, a subject is considered to be enrolled in the study. All enrolled subjects will undergo an observational stage evaluating endotracheal colonization. Subjects who are randomized will undergo a treatment, monitoring, and follow-up period. Approximately 2250 eligible subjects who meet all of the inclusion criteria and none of the exclusion criteria will be screened daily (while mechanically ventilated) for up to 8 days to identify those subjects who are heavily colonized with S. aureus. Upon determination of eligibility, approximately 354 subjects will be randomized in a 1:1 ratio to 1 of 2 treatment groups i.e ASN 100 or placebo. The primary objective of this study is to evaluate the safety, tolerability, and efficacy of a single dose of ASN100 (administered as ASN-1 and ASN-2 components) versus placebo for the prevention of S. aureus pneumonia in mechanically ventilated subjects who are heavily colonized with S. aureus. The secondary objectives of this study are to compare the duration of mechanical ventilation, length of stay in the intensive care unit (ICU), determine the serum pharmacokinetics (PK), compare 28-day all-cause mortality post-treatment in subjects treated with ASN100 versus placebo. 

An independent Data Review Committee (DRC) performed a pre-specified interim futility analysis for Study ASN100-201.  The review was based on 118 randomized and treated subjects who reached Study Day 28, to capture the study visits at which the primary and secondary outcome assessments are performed. The futility analysis was conducted in one third of the planned sample size by the independent DRC and it was concluded that it would be futile to continue the study to completion.  Therefore, the Sponsor, Arsanis, Inc., has decided to terminate the clinical study based on the DRC recommendation of futility. The decision to terminate the study is based on the low probability of meeting the primary efficacy endpoint and not based on an evaluation of the ASN100 safety. 


 
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