Bacteremia, Bacteremia Due to Staphylococcus Aureus, Bacteremia Staph, Staphylococcus Aureus, Staphylococcus Aureus Bacteremia
Conditions
Keywords
Bacteriophage, Phage, Bacteremia, Staphylococcus Aureus, Staphylococcus, SAB
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.
Interventions
BIOLOGICALAP-SA02
Bacteriophage administered via intravenous bolus infusion
OTHERPlacebo
Inactive Placebo administered via intravenous bolus infusion
Sponsors
Armata Pharmaceuticals, Inc.
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized, double-blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Following Multiple Doses of Intravenous AP-Sa02. | Day 1 first dose through Day 12 or through EOS (28 days after BAT) (Day 39-81). | Incidence and severity of treatment-emergent adverse events as assessed by CTCAE v4.0. Per SAP, all patients with uncomplicated SAB (Phase 1 Cohort 1 and Cohort 2) will be combined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Improvement or Response at Day 12 | 12 Days | Description of clinical outcome in the Intent-to-Treat (ITT) 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 as Assessed by the Investigator | 7 days post completion of best available antibiotic therapy, up to 60 days. | Description of clinical outcome in the Intent-to-Treat (ITT) 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 Assessed by the CEAC | 7 days post completion of best available antibiotic therapy, up to 60 days. | Description of clinical outcome in the Intent-to-Treat (ITT) 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 as Assessed by the Investigator at 28 Days Post Completion of Best Available Antibiotic Therapy | 28 days post completion of best available antibiotic therapy, up to 81 days. | Description of clinical outcome in the Intent-to-Treat (ITT) 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 as Assessed by the CEAC at 28 Days Post Completion of Best Available Antibiotic Therapy | 28 days post completion of best available antibiotic therapy, up to 81 days. | Description of clinical outcome in the Intent-to-Treat (ITT) 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. |
Countries
Australia, United States
Contacts
STUDY_DIRECTORDeborah Birx, MD
Armata Pharmaceuticals, Inc.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Australia | 1 participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 29 | 0 / 13 | 0 / 3 | 0 / 3 | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 19 / 29 | 12 / 13 | 3 / 3 | 2 / 3 | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 4 / 29 | 3 / 13 | 3 / 3 | 2 / 3 | 1 / 1 | 0 / 1 |
Outcome results
None listed