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
Brief Title
Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
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.
Completion Date
Completion Date Type
Actual
Conditions
Bacteremia
Staphylococcus Aureus
Staphylococcus Aureus Bacteremia
Bacteremia Staph
Bacteremia Due to Staphylococcus Aureus
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Bacteriophage
Phage
Bacteremia
Staphylococcus Aureus
Staphylococcus
SAB
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05184764
Org Class
Industry
Org Full Name
Armata Pharmaceuticals, Inc.
Org Study Id
AP-SA02-101
Overall Status
Completed
Phases
Phase 1
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Incidence and severity of treatment-emergent adverse events as assessed by CTCAE v4.0
Outcome Measure
Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) of multiple doses of intravenous AP-SA02
Outcome Time Frame
Day 1 first dose through Day 12 or through End of Study for serious AEs
Secondary Outcomes
Outcome 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
Outcome Time Frame
Day 12
Outcome Measure
Clinical Improvement or Response at Day 12
Outcome 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
Outcome Time Frame
7 days post completion of best available antibiotic therapy
Outcome Measure
Clinical Improvement or Response at 7 days after completion of antibiotic therapy
Outcome 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
Outcome Time Frame
28 days post completion of best available antibiotic therapy
Outcome Measure
Clinical Improvement or Response at End of Study
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Paul Riska
Investigator Email
priska@montefiore.org
Investigator Phone
718-020-6494