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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05184764




Registration number
NCT05184764
Ethics application status
Date submitted
24/11/2021
Date registered
11/01/2022

Titles & IDs
Public title
Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
Scientific 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
Secondary ID [1] 0 0
AP-SA02-101
Universal Trial Number (UTN)
Trial acronym
diSArm
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacteremia 0 0
Staphylococcus Aureus 0 0
Staphylococcus Aureus Bacteremia 0 0
Bacteremia Staph 0 0
Bacteremia Due to Staphylococcus Aureus 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - AP-SA02
Other interventions - Placebo

Experimental: AP-SA02 - Anti-staphylococcal bacteriophage

Placebo comparator: Placebo - Inactive isotonic solution


Treatment: Other: AP-SA02
Bacteriophage administered via intravenous bolus infusion

Other interventions: Placebo
Inactive Placebo administered via intravenous bolus infusion
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) of multiple doses of intravenous AP-SA02
Timepoint [1] 0 0
Day 1 first dose through Day 12 or through End of Study for serious AEs
Secondary outcome [1] 0 0
Clinical Improvement or Response at Day 12
Timepoint [1] 0 0
Day 12
Secondary outcome [2] 0 0
Clinical Improvement or Response at 7 days after completion of antibiotic therapy
Timepoint [2] 0 0
7 days post completion of best available antibiotic therapy
Secondary outcome [3] 0 0
Clinical Improvement or Response at End of Study
Timepoint [3] 0 0
28 days post completion of best available antibiotic therapy

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Rhode Island
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Armata Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
United States Department of Defense
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mina Pastagia, MD, MS
Address 0 0
Armata Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Thomas Feinberg
Address 0 0
Country 0 0
Phone 0 0
781-820-2787
Fax 0 0
Email 0 0
tfeinberg@armatapharma.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05184764