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

Sponsor

Armata Pharmaceuticals, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05184764

Collaborator

United States Department of Defense (U.S. Fed)

Enrollment

Locations

Arms

19.2

Anticipated Duration (Months)

12.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Bacteremia Staphylococcus Aureus Staphylococcus Aureus Bacteremia Bacteremia Staph Bacteremia Due to Staphylococcus Aureus	Biological: AP-SA02 Other: Placebo	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, double-blind, placebo-controlledRandomized, double-blind, placebo-controlled

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 26, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AP-SA02 Anti-staphylococcal bacteriophage	Biological: AP-SA02 Bacteriophage administered via intravenous bolus infusion
Placebo Comparator: Placebo Inactive isotonic solution	Other: Placebo Inactive Placebo administered via intravenous bolus infusion

Arm

Intervention/Treatment

Experimental: AP-SA02

Anti-staphylococcal bacteriophage

Biological: AP-SA02

Bacteriophage administered via intravenous bolus infusion

Placebo Comparator: Placebo

Inactive isotonic solution

Other: Placebo

Inactive Placebo administered via intravenous bolus infusion

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) of multiple doses of intravenous AP-SA02 [Day 1 first dose through Day 12 or through End of Study for serious AEs]
Incidence and severity of treatment-emergent adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Clinical Improvement or Response at Day 12 [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 [7 days post completion of best available 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 [28 days post completion of best available 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford Health System	Detroit	Michigan	United States	48202
2	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
3	Portland Veterans Affairs Medical Center	Portland	Oregon	United States	97239
4	Rhode Island Hospital	Providence	Rhode Island	United States	02903