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

NCT05184764 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-03-23

Study results available
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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

Conditions

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

Interventions

BIOLOGICAL

AP-SA02

Bacteriophage administered via intravenous bolus infusion

OTHER

Placebo

Inactive Placebo administered via intravenous bolus infusion

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Armata Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Deborah Birx, MD · Armata Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-26
Primary Completion
2024-11-07
Completion
2025-01-14
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05184764 on ClinicalTrials.gov