Prosthetic Joint InfectionPhase 1/2ACTIVE1NCT05269121
Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections
A Phase 1/2 study testing Phage Therapy in people with Prosthetic Joint Infection and Bacterial Infections, run by Adaptive Phage Therapeutics, Inc..
Trial summary
This study will test the feasibility of a regimen of intraoperative (IO) and intravenous (IV) PhageBank™ bacteriophage therapy in conjunction with a DAIR procedure to cure chronic prosthetic joint infection (PJI) without replacement of the prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection, Bacterial Infections
- What is being tested?
- Phage Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Nov 2024
- Phase
- Phase 1/2
- 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.
- Stopped or not received SAT for 2 weeks
- Female patients of childbearing potential who agree to use contraception.
- First time chronic prosthetic joint infection
- 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
- Unable to tolerate SAT
- Septic shock or hemodynamic instability.
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- Chronic kidney disease
- Liver disease
- Decompensated heart failure.
- Positive drug screen
- Receiving chemotherapy
- Immunocompromised
- Antiviral treatment within 2 weeks prior to DAIR
- Currently participating in another clinical trial
- Known phage allergy
- Pregnant/ breastfeeding
- Lack of capacity to consent
About this study
Official title: An Open-Label Multicenter Study to Evaluate the Safety and Efficacy of PhageBank™ Phage Therapy in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) for Patients With First Time Culture Proven Chronic Prosthetic Joint Infection
This study will test the feasibility of a regimen of intraoperative (IO) and intravenous (IV) PhageBank™ bacteriophage therapy in conjunction with a DAIR procedure to cure chronic prosthetic joint infection (PJI) without replacement of the prosthesis.
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 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.
This study will compare the safety and efficacy of phage therapy in conjunction with standard of care antibiotics and a DAIR procedure.
- Conditions
- Prosthetic Joint Infection, Bacterial Infections
- Being tested
- Phage Therapy
- Keywords
- Prosthetic, Joint, Knee, Hip, Phage, Bacteriophage, Prosthetic Joint, DAIR
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phage TherapyBiological
Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.
| Study group | Role | What they receive |
|---|---|---|
| DAIR + Phage Treatment + Antibiotics | Experimental | Phage therapy will be administered in conjunction with antibiotics. Receives: Biological: Phage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection
Incidence of reactions to study treatment and discontinuation due to adverse events
Measured: Day 1 through Week 24
Treatment success
No recurrence or evidence of infection with the original pathogen at the same joint
Measured: 13 months after DAIR
Secondary outcomes (1)
No recurrence or evidence of infection for any reason
Infection due to the original or different pathogen at the index site
Measured: 3, 6, 13, or 24 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 startSep 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2024 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptive Phage Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Hopkins, MD, Study chair, Adaptive Phage Therapeutics, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269121
- Sponsor's protocol ID
- APT.PJI.002
- Acronym
- ACTIVE1
- Status last verified
- Feb 2024
- First submitted
- 25 Feb 2022
- Last updated
- 22 Feb 2024
- 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 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Multicenter Study to Evaluate the Safety and Efficacy of PhageBank™ Phage Therapy in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) for Patients With First Time Culture Proven Chronic Prosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT05269121
- Acronym / sponsor ID
- ACTIVE1 / APT.PJI.002
- Conditions
- Prosthetic Joint Infection, Bacterial Infections
- Keywords
- Prosthetic, Joint, Knee, Hip, Phage, Bacteriophage, Prosthetic Joint, DAIR
- Phase
- Phase 1/2
- 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
- Sep 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2024 (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 study will test the feasibility of a regimen of intraoperative (IO) and intravenous (IV) PhageBank™ bacteriophage therapy in conjunction with a DAIR procedure to cure chronic prosthetic joint infection (PJI) without replacement of the prosthesis.
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 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.
This study will compare the safety and efficacy of phage therapy in conjunction with standard of care antibiotics and a DAIR procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DAIR + Phage Treatment + Antibiotics | Experimental | Biological: Phage TherapyPhage therapy will be administered in conjunction with antibiotics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females ≥18 years of age.
- Stopped or not received SAT for 2 weeks
- Female patients of childbearing potential who agree to use contraception.
- First time chronic prosthetic joint infection
- Confirmed phage match
Key exclusion criteria (17 listed)
- Soft tissue defect requiring reconstruction.
- Hardware misalignment
- Additional orthopedic hardware in connection with the infected prosthesis.
- Active infection
- 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 |
|---|---|---|
| Phage TherapyPatient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment. | Biological | DAIR + Phage Treatment + Antibiotics |
Primary outcome
To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection
Time frame: Day 1 through Week 24
Incidence of reactions to study treatment and discontinuation due to adverse events
Treatment success
Time frame: 13 months after DAIR
No recurrence or evidence of infection with the original pathogen at the same joint
1 secondary outcome
No recurrence or evidence of infection for any reason
Time frame: 3, 6, 13, or 24 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 22 Feb 2024.
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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.
Robert Hopkins, MD study chair
Adaptive Phage Therapeutics, Chief Medical Officer
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phage Therapy in people with Prosthetic Joint Infection and Bacterial Infections, run by Adaptive Phage Therapeutics, Inc..
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 6 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 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection (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 22 Feb 2024.