Prosthetic Joint InfectionPhase 2ACTIVE2NCT05269134
Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
A Phase 2 study testing Bacteriophage in people with Prosthetic Joint Infection, run by Adaptive Phage Therapeutics, Inc. at 10 sites in United States.
Trial summary
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection
- What is being tested?
- Bacteriophage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 10 sitesUnited States
- Study dates
- 27 Mar 2023to Jul 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥18 years of age
- Recurrent PJI of the knee or hip
- Female patients of childbearing potential who agree to use contraception.
- Confirmed phage match
- No anticipated need for long-term antibiotics
Who cannot join
- Soft tissue defect requiring reconstruction
- Hardware misalignment
- Additional orthopedic hardware in connection with the infected prosthesis
- Active infection (other than PJI) requiring long term IV antibiotics
- Unable to tolerate SAT
- Septic shock or hemodynamic instability
Show all 17Show fewer
- Stage 4 or greater chronic kidney disease
- Liver disease
- Decompensated heart failure
- Positive drug screen
- Receiving chemotherapy
- Immunocompromised
- Treatment with antiviral medication within 2 weeks prior to randomization
- Currently participating in another clinical trial
- Known phage allergy
- Pregnant/ breast feeding
- Lack of capacity to consent
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Brigham & Women's Hospital
Boston, Massachusetts, 02115
New England Baptist Hospital
Boston, Massachusetts, 02120
Hartford Health Care Bone & Joint Insitute
Hartford, Connecticut, 06106
Snake River Research
Idaho Falls, Idaho, 83404
WVU Medicine JW Ruby Memorial Hospital
Morgantown, West Virginia, 26506
Mayo Clinic
Rochester, Minnesota, 55905
William Beaumont Hospital
Royal Oak, Michigan, 48073
University of California San Diego Medical Center
San Diego, California, 92037
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of APT Phage Bank Phage Therapy Versus Placebo in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) in Subjects With Chronic Prosthetic Joint Infection (PJI)
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
Read the detailed description
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by at least 1 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, or Klebsiella pneumoniae.
This study will compare the safety and efficacy of DAIR procedure + Phage Therapy + Antibiotics versus DAIR procedure + Placebo + Antibiotics.
- Conditions
- Prosthetic Joint Infection
- Being tested
- Bacteriophage, Placebo
- Keywords
- Prosthetic, Joint, Knee, Hip, Phage, Bacteriophage, Prosthetic Joint, DAIR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BacteriophageDrug
Phage Therapy
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| DAIR + Phage Treatment + Antibiotics | Experimental | Phage therapy will be administered in conjunction with antibiotic treatment. Receives: Drug: Bacteriophage |
| DAIR + Placebo + Antibiotics | Placebo comparator | Placebo will be administered in conjunction with antibiotic treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI
Incidence of reactions to study treatment and discontinuation due to adverse events
Measured: Day 1 through Week 24
To evaluate the efficacy of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI
Time to recurrence or evidence of infection with the original pathogen at the same joint
Measured: Day 1 through 24 months
Secondary outcomes (2)
Treatment success
No recurrence or evidence of infection with the original pathogen at the same joint
Measured: Day 1 through 12 months
No recurrence or evidence of infection for any reason
Infection due to the original pathogen or a different pathogen
Measured: 12 months after DAIR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start27 Mar 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2027 (estimated)
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Joint InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptive Phage Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Fang, MD, Study chair, Adaptive Phage Therapeutics, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269134
- Sponsor's protocol ID
- APT.PJI.006
- Acronym
- ACTIVE2
- Status last verified
- Oct 2023
- First submitted
- 25 Feb 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of APT Phage Bank Phage Therapy Versus Placebo in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) in Subjects With Chronic Prosthetic Joint Infection (PJI)
- ClinicalTrials.gov ID
- NCT05269134
- Acronym / sponsor ID
- ACTIVE2 / APT.PJI.006
- Conditions
- Prosthetic Joint Infection
- Keywords
- Prosthetic, Joint, Knee, Hip, Phage, Bacteriophage, Prosthetic Joint, DAIR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Adaptive Phage Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
Detailed description
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by at least 1 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, or Klebsiella pneumoniae.
This study will compare the safety and efficacy of DAIR procedure + Phage Therapy + Antibiotics versus DAIR procedure + Placebo + Antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAIR + Phage Treatment + Antibiotics | Experimental | Drug: BacteriophagePhage therapy will be administered in conjunction with antibiotic treatment. |
| DAIR + Placebo + Antibiotics | Placebo comparator | Drug: PlaceboPlacebo will be administered in conjunction with antibiotic treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females ≥18 years of age
- Recurrent PJI of the knee or hip
- Female patients of childbearing potential who agree to use contraception.
- Confirmed phage match
- No anticipated need for long-term antibiotics
Key exclusion criteria (17 listed)
- Soft tissue defect requiring reconstruction
- Hardware misalignment
- Additional orthopedic hardware in connection with the infected prosthesis
- Active infection (other than PJI) requiring long term IV antibiotics
- Unable to tolerate SAT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BacteriophagePhage Therapy | Drug | DAIR + Phage Treatment + Antibiotics |
| PlaceboPlacebo | Drug | DAIR + Placebo + Antibiotics |
Primary outcome
To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI
Time frame: Day 1 through Week 24
Incidence of reactions to study treatment and discontinuation due to adverse events
To evaluate the efficacy of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI
Time frame: Day 1 through 24 months
Time to recurrence or evidence of infection with the original pathogen at the same joint
2 secondary outcomes
Treatment success
Time frame: Day 1 through 12 months
No recurrence or evidence of infection for any reason
Time frame: 12 months after DAIR
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
Related trials for Prosthetic Joint Infection
Recruiting
Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
Prosthetic Joint Infection of Knee
RecruitingPhase 2
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
Prosthetic Joint Infection (PJI)
RecruitingPhase 2/3
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
Prosthetic-joint Infection
Not yet recruitingObservational study
oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study
Arthroplasty, Arthroplasty Replacement, Knee
Recruiting
Detection of Biomarkers for Prosthetic Infection Type - (DEBIT)
Prosthetic Joint Infection (PJI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Fang, MD study chair
Adaptive Phage Therapeutics, Chief Medical Officer
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bacteriophage in people with Prosthetic Joint Infection, run by Adaptive Phage Therapeutics, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI (time frame: Day 1 through Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.