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Virus Therapy

Bacteriophage for Prosthetic Joint Infections (ACTIVE2 Trial)

Phase 2
Waitlist Available
Research Sponsored by Adaptive Phage Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after dair
Awards & highlights

ACTIVE2 Trial Summary

This trial tests if viruses can help treat people with long-term infections in artificial joints.

Eligible Conditions
  • Prosthetic Joint Infections

ACTIVE2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after dair
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after dair for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the efficacy of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI
To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI
Secondary outcome measures
No recurrence or evidence of infection for any reason
Treatment success

ACTIVE2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DAIR + Phage Treatment + AntibioticsExperimental Treatment1 Intervention
Phage therapy will be administered in conjunction with antibiotic treatment.
Group II: DAIR + Placebo + AntibioticsPlacebo Group1 Intervention
Placebo will be administered in conjunction with antibiotic treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bacteriophage
2006
Completed Phase 1
~130

Find a Location

Who is running the clinical trial?

Adaptive Phage Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
127 Total Patients Enrolled
2 Trials studying Prosthetic Joint Infections
Robert Hopkins, MDStudy ChairAdaptive Phage Therapeutics, Chief Medical Officer
2 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Prosthetic Joint Infections
Edward Fang, MDStudy ChairAdaptive Phage Therapeutics, Chief Medical Officer
1 Previous Clinical Trials
126 Total Patients Enrolled

Media Library

Bacteriophage (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05269134 — Phase 2
Prosthetic Joint Infections Research Study Groups: DAIR + Phage Treatment + Antibiotics, DAIR + Placebo + Antibiotics
Prosthetic Joint Infections Clinical Trial 2023: Bacteriophage Highlights & Side Effects. Trial Name: NCT05269134 — Phase 2
Bacteriophage (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05269134 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment capacity for this medical study?

"This trial necessitates the enrollment of 90 suitable patients, with potential locations including Sinai Hospital of Baltimore in Maryland and Brigham & Women's Hospital in Massachusetts."

Answered by AI

What side effects might be associated with DAIR + Phage Treatment + Antibiotics?

"The safety of this combination treatment (DAIR + Phage Treatment + Antibiotics) has been assessed as a 2 based on the Phase 2 trial data, with some evidence to support its security but no proof of efficacy."

Answered by AI

Are there still opportunities for people to become involved in the research?

"Affirmative. According to clinicaltrials.gov, this scientific investigation is actively searching for research participants and was initially posted on March 27th 2023. The most recent update was June 2nd 2023, with the aim of recruiting 90 people from 5 separate sites."

Answered by AI

In what regions of North America is this analysis being conducted?

"This experimental medical trial is accepting patients at Sinai Hospital in Baltimore, MD; Brigham & Women's Hospital of Boston, MA and New England Baptist Hospital in Morgantown, WV along with 5 other health care facilities."

Answered by AI

Who else is applying?

What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I have had 3 revisions and am currently on suppressive antibiotics for a pji the doctors tell me that the only thing they can do now is to amputate my leg if the antibiotics don’t keep it suppressed I have been studying phage therapy and think they might be my only hope to save my leg.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
2023. "Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05269134.
~0 spots leftby Jul 2025
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