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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/04/013442
• Date of registration: 24-04-2018
• Prospective Registration: Yes
• Primary sponsor: Arsanis Inc
• Public title: Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus
• Scientific 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
• Date of first enrolment: 04-05-2018
• Target sample size: 354
• Recruitment status: Other (Terminated)
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=23771
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 2

Countries of recruitment

Algeria, Czech Republic, France, Georgia, Germany, Hungary, Israel, Poland, Portugal, Romania, Russian Federation, Serbia , South Africa, Spain, Ukraine, United States of America

Contacts

• Name: TV Thanuja Naidu
• Affiliation: Pharm-Olam International (India) Pvt. Ltd

• Name: TV Thanuja Naidu
• Affiliation: Pharm-Olam International (India) Pvt. Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 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 Investigatorâ??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.


Exclusion criteria: 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 Investigatorâ??s opinion,

would interfere with the conduct of the study or jeopardize the subjectâ??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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Prevention of Staphylococcus aureus Pneumonia in Heavily Colonized, Mechanically Ventilated Subjects

Intervention(s)

Intervention1: 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)
Control Intervention1: Placebo: administered either sequentially or simultaneously as 2 separate IV infusions: Placebo: administered either sequentially or simultaneously as 2 separate IV infusions

Primary Outcome(s)

Proportion of subjects in MITT population who develop S. aureus pneumoniaTimepoint: Up to day 22

Secondary Outcome(s)

All cause mortalityTimepoint: 28 days

Duration of mechanical ventilationTimepoint: 21 day

Length of ICU stayTimepoint: 21 days

Secondary ID(s)

ASN100-201, Ver 4.0 dated 02May2017

Source(s) of Monetary Support

Arsanis Inc, 890 Winter Street, Suite 230 Waltham, MA 02451-1472

Ethics review

Status: Approved
Approval date: 30/01/2018
Contact:

Institutional Ethics Committee, Apollo Hospitals (Apollo Health City)

Status: Approved
Approval date: 30/01/2018
Contact:

Institutional Ethics Committee, Poona Medical Research Foundation

Status: Approved
Approval date: 21/04/2018
Contact:

Ethics Committee of Bangalore Medical College & Research Institute

Status: Approved
Approval date: 21/06/2018
Contact:

Institutional Ethics Committee, Government Medical College and Hospital, Nagpur

Status: Not Approved
Approval date:
Contact:

Ethics committee of S M S Medical College & Attached Hospitals

Results

• Date Completed: 25/06/2018