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Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia (diSArm)

Primary Purpose

Bacteremia, Staphylococcus Aureus, Staphylococcus Aureus Bacteremia

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AP-SA02
Placebo
Sponsored by
Armata Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacteremia focused on measuring Bacteriophage, Phage, Bacteremia, Staphylococcus Aureus, Staphylococcus, SAB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • A hospitalized female or male ≥ 18 years old
  • Positive blood culture for Staphylococcus aureus (SA)
  • Source of SA infection controlled, or a plan for source control, if relevant
  • Not pregnant or breastfeeding and is not of reproductive potential or agrees to use contraception if or reproductive potential

Key Exclusion Criteria:

  • Concomitant growth of organisms besides SA
  • Left-sided infectious endocarditis by modified Duke criteria
  • Known or suspected brain abscess or meningitis
  • Known allergy to phage products

Sites / Locations

  • University of California, San Diego (UCSD) - Medical CenterRecruiting
  • University of California, Los Angeles (UCLA) - Medical CenterRecruiting
  • University of Florida (UF) - Division of Infectious DiseaseRecruiting
  • University of South FloridaRecruiting
  • Johns Hopkins UniversityRecruiting
  • Tufts Medical CenterRecruiting
  • University of MichiganRecruiting
  • Henry Ford Health SystemRecruiting
  • Montefiore Medical CenterRecruiting
  • The Jamaica Hospital Medical CenterRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Wake Forest University Health SciencesRecruiting
  • Portland Veterans Affairs Medical CenterRecruiting
  • Rhode Island HospitalRecruiting
  • Froedtert Hospital and the Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AP-SA02

Placebo

Arm Description

Anti-staphylococcal bacteriophage

Inactive isotonic solution

Outcomes

Primary Outcome Measures

Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) of multiple doses of intravenous AP-SA02
Incidence and severity of treatment-emergent adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Clinical Improvement or Response at Day 12
Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia
Clinical Improvement or Response at 7 days after completion of antibiotic therapy
Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia
Clinical Improvement or Response at End of Study
Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia

Full Information

First Posted
November 24, 2021
Last Updated
May 22, 2023
Sponsor
Armata Pharmaceuticals, Inc.
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05184764
Brief Title
Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
Acronym
diSArm
Official Title
Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Safety, Tolerability, and Efficacy of Intravenous AP-SA02 as an Adjunct to Best Available Antibiotic Therapy for the Treatment of Adults With Bacteremia Due to Staphylococcus Aureus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Armata Pharmaceuticals, Inc.
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Escalation Study of the Safety, Tolerability, and Efficacy of Intravenous AP SA02 as an Adjunct to Best Available Antibiotic Therapy Compared to Best Available Antibiotic Therapy Alone for the Treatment of Adults With Bacteremia Due to Staphylococcus aureus
Detailed Description
This study will be conducted in two phases: Phase 1b will to evaluate the safety and tolerability of multiple ascending intravenous (IV) doses of AP-SA02 or placebo as an adjunct to best available therapy (BAT) compared to BAT alone in subjects with SA bacteremia (SAB). Phase 2a will evaluate the efficacy, safety, and tolerability of multiple doses of AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated SAB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia, Staphylococcus Aureus, Staphylococcus Aureus Bacteremia, Bacteremia Staph, Bacteremia Due to Staphylococcus Aureus
Keywords
Bacteriophage, Phage, Bacteremia, Staphylococcus Aureus, Staphylococcus, SAB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AP-SA02
Arm Type
Experimental
Arm Description
Anti-staphylococcal bacteriophage
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inactive isotonic solution
Intervention Type
Biological
Intervention Name(s)
AP-SA02
Intervention Description
Bacteriophage administered via intravenous bolus infusion
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Inactive Placebo administered via intravenous bolus infusion
Primary Outcome Measure Information:
Title
Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) of multiple doses of intravenous AP-SA02
Description
Incidence and severity of treatment-emergent adverse events as assessed by CTCAE v4.0
Time Frame
Day 1 first dose through Day 12 or through End of Study for serious AEs
Secondary Outcome Measure Information:
Title
Clinical Improvement or Response at Day 12
Description
Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia
Time Frame
Day 12
Title
Clinical Improvement or Response at 7 days after completion of antibiotic therapy
Description
Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia
Time Frame
7 days post completion of best available antibiotic therapy
Title
Clinical Improvement or Response at End of Study
Description
Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia
Time Frame
28 days post completion of best available antibiotic therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: A hospitalized female or male ≥ 18 years old Positive blood culture for Staphylococcus aureus (SA) Source of SA infection controlled, or a plan for source control, if relevant Not pregnant or breastfeeding and is not of reproductive potential or agrees to use contraception if or reproductive potential Key Exclusion Criteria: Concomitant growth of organisms besides SA Left-sided infectious endocarditis by modified Duke criteria Known or suspected brain abscess or meningitis Known allergy to phage products
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bryan Kadotani
Phone
310-665-2928
Email
bkadotani@armatapharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Kyme, PhD
Phone
310-665-2928
Ext
234
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mina Pastagia, MD, MS
Organizational Affiliation
Armata Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San Diego (UCSD) - Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Lampley
Phone
619-543-3108
Email
elampley@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Saima Aslam, MD
Facility Name
University of California, Los Angeles (UCLA) - Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yesenia Calzada
Email
ycalzada@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Paul Allyn, MD
Facility Name
University of Florida (UF) - Division of Infectious Disease
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Alcala
Email
rodrigo.alcala@medicine.ufl.edu
First Name & Middle Initial & Last Name & Degree
Gary Wang, MD
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avennette Pinto
Phone
813-974-5891
Email
apinto3@usf.edu
First Name & Middle Initial & Last Name & Degree
Kami Kim, MD
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Stelmash
Phone
410-550-1131
Email
lstelma2@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Mamuka Machaidze, MD
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupali Ranade
Email
rranade@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Brian Chow, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Hussain
Phone
734-763-5219
First Name & Middle Initial & Last Name & Degree
Jihoon Baang, MD
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Resk
Email
mresk1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Katrina Williams
Phone
313-916-5401
Email
KWILLI35@hfhs.org
First Name & Middle Initial & Last Name & Degree
Mayur S Ramesh, MD
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bola Omotosho
Phone
718-920-6565
Email
Jomotosh@montefiore.org
First Name & Middle Initial & Last Name & Degree
Paul Riska, MD
Facility Name
The Jamaica Hospital Medical Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Cervellione
Phone
646-872-8659
Email
kcervell@jhmc.org
First Name & Middle Initial & Last Name & Degree
Khalid Gafoor, MD
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Zhan
Phone
347-306-2156
Email
hui.zhan@mssm.edu
First Name & Middle Initial & Last Name & Degree
Deena Altman, MD
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Zieser-Misenheimer
Phone
336-716-0275
Email
ezieserm@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
John Sanders, MD, MPH
Facility Name
Portland Veterans Affairs Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katelyn West
Phone
971-222-7914
Email
katelyn.west@va.gov
First Name & Middle Initial & Last Name & Degree
Christopher Pfeiffer, MD
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fadi Shehadeh
Phone
401-444-4969
Email
fanti.sechante@lifespan.org
First Name & Middle Initial & Last Name & Degree
Eleftherios Mylonakis, MD
Facility Name
Froedtert Hospital and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonija Parker
Email
smparker@mcw.edu
First Name & Middle Initial & Last Name & Degree
Jane Wainaina, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://armatapharma.com
Description
Armata Pharmaceuticals, Inc.

Learn more about this trial

Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia

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