Save

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

PHASE1PHASE2RECRUITING

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.

Simpliy with AI

Study details:

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.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-04-26

Primary completion: 2024-12-01

Study completion finish: 2025-03-01

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT05184764

Intervention or treatment

BIOLOGICAL: AP-SA02

OTHER: Placebo

Conditions

• Bacteremia
• Staphylococcus Aureus Bacteremia
• Staphylococcus Aureus
• Bacteremia Staph
• Bacteremia Due to Staphylococcus Aureus

Condition: Bacteremia, Staphylococcus Aureus Bacteremia and more
BIOLOGICAL: AP-SA02 and other drugs
Adelaide, Not Specified, Australia and more
Sponsor: Armata Pharmaceuticals, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Adelaide Hospital

Research sites nearby

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, Not Specified, Australia
Royal Melbourne Hospital
Melbourne, Not Specified, Australia
Westmead Hospital
Westmead, Not Specified, Australia
Monash Health
Clayton, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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	Day 1 first dose through Day 12 or through End of Study for serious AEs

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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	Day 12
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	7 days post completion of best available antibiotic therapy
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	28 days post completion of best available antibiotic therapy

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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