Prosthetic Joint InfectionPhase 1/2NCT04787250
Bacteriophage Therapy in Patients With Prosthetic Joint Infections
A Phase 1/2 study testing Phage Therapy and Two-Stage Exchange Arthroplasty in people with Prosthetic Joint Infection, run by Adaptive Phage Therapeutics, Inc. at 1 site 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?
- Phage Therapy and Two-Stage Exchange Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2022to May 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
General Inclusion Criteria:
- Males or females ≥18 years of age.
- Female patients of childbearing potential who agree to use contraception.
- Candidate for a two-stage exchange arthroplasty.
- Chronic prosthetic joint infection
General Exclusion Criteria:
- Prior history of prosthetic joint infections (PJI) of same joint treated surgically other than one prior Debridement Antibiotics and Implant Retention procedure
- Soft tissue defect requiring reconstruction
- Hardware misalignment or loosening
- Active osteomyelitis
- Septic shock or hemodynamic instability
- Stage 4 or greater chronic kidney disease
- Liver disease
- Decompensated cirrhosis
- Alcohol abuse or alcohol induced liver disease or non-alcoholic steatohepatitis
- Decompensated heart failure
- Any other clinically significant disease, per judgement of the investigator
- Neutropenia (neutrophil count < 1000 cells/cubic mm), thrombocytopenia (platelets < 50,000/cubic mm) or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 3 time the upper limit of normal
- HIV, hepatitis C, hepatitis B infection
- Positive drug screen
- Receipt of chemotherapy, immunosuppressants or immune modulators
- Anti-viral medication
- Any known phage allergy
- Breast feeding or pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Open Label, Parallel Group, Controlled Study to Evaluate the Safety and Surgery Sparing Effect of Phage Therapy With Antibiotics for Patients With Prosthetic Joint Infections Who Are Candidates for Two Stage Exchange Arthroplasty
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 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus sp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.
This study will also compare the safety and efficacy of phage therapy in conjunction with antibiotics versus standard of care (SOC) two-stage exchange arthroplasty plus antibiotics.
- Conditions
- Prosthetic Joint Infection
- Being tested
- Phage Therapy, Two-Stage Exchange Arthroplasty
- Keywords
- Prosthetic, Joint, Knee, Hip, Phage, Bacteriophage, Prosthetic Joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phage TherapyBiological
Also called Antibiotics
Phage will be administered based on patient's matching results.
Two-Stage Exchange ArthroplastyProcedure or surgery
Also called Antibiotics
Performed per the study center's standard of care. No investigational products are used.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1, Phage Therapy with Antibiotic Treatment | Experimental | Phage therapy will be administered in conjunction with antibiotic treatment. Receives: Biological: Phage Therapy |
| Arm 2, Standard of Care | Active comparator | Two-stage exchange arthroplasty entails resection arthroplasty and placement of an antibiotic-loaded spacer, antibiotic therapy, an antibiotic-free observation period, and re-implantation of a new prosthesis. Receives: Procedure: Two-Stage Exchange Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of phage therapy
Incidence and type of adverse events and infusion reactions
Measured: Day 1 through Week 26
Secondary outcomes (3)
Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections.
Proportion of phage-treated patients with no need for surgery by no evidence of a prosthetic joint infection.
Measured: 6 weeks after completion of phage therapy
Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS).
Time to reach minimum clinically important difference in hip dysfunction and osteoarthritis outcome score.
Measured: Week 26
Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS).
Time to reach minimum clinically important difference in knee injury and osteoarthritis outcome score.
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study startOct 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2024 (estimated)
Why it stopped: Changes to protocol design
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, open-label, parallel-group design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptive Phage Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Robert J Hopkins, MD, Study director, Adaptive Phage Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787250
- Sponsor's protocol ID
- APT.PJI.001
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2021
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Label, Parallel Group, Controlled Study to Evaluate the Safety and Surgery Sparing Effect of Phage Therapy With Antibiotics for Patients With Prosthetic Joint Infections Who Are Candidates for Two Stage Exchange Arthroplasty
- ClinicalTrials.gov ID
- NCT04787250
- Acronym / sponsor ID
- APT.PJI.001
- Conditions
- Prosthetic Joint Infection
- Keywords
- Prosthetic, Joint, Knee, Hip, Phage, Bacteriophage, Prosthetic Joint
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes to protocol design
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Adaptive Phage Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- Oct 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 8 Mar 2021 (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 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus sp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.
This study will also compare the safety and efficacy of phage therapy in conjunction with antibiotics versus standard of care (SOC) two-stage exchange arthroplasty plus antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, open-label, parallel-group design
| Arm | Type | Receives |
|---|---|---|
| Arm 1, Phage Therapy with Antibiotic Treatment | Experimental | Biological: Phage TherapyPhage therapy will be administered in conjunction with antibiotic treatment. |
| Arm 2, Standard of Care | Active comparator | Procedure: Two-Stage Exchange ArthroplastyTwo-stage exchange arthroplasty entails resection arthroplasty and placement of an antibiotic-loaded spacer, antibiotic therapy, an antibiotic-free observation period, and re-implantation of a new prosthesis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 TherapyAlso: AntibioticsPhage will be administered based on patient's matching results. | Biological | Arm 1, Phage Therapy with Antibiotic Treatment |
| Two-Stage Exchange ArthroplastyAlso: AntibioticsPerformed per the study center's standard of care. No investigational products are used. | Procedure or surgery | Arm 2, Standard of Care |
Primary outcome
Safety and tolerability of phage therapy
Time frame: Day 1 through Week 26
Incidence and type of adverse events and infusion reactions
3 secondary outcomes
Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections.
Time frame: 6 weeks after completion of phage therapy
Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS).
Time frame: Week 26
Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS).
Time frame: Week 26
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 4 Apr 2022.
- Individual participant dataSharing planned: No
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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 J Hopkins, MD study director
Adaptive Phage Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phage Therapy and Two-Stage Exchange Arthroplasty in people with Prosthetic Joint Infection, run by Adaptive Phage Therapeutics, Inc. at 1 site 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?
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 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Safety and tolerability of phage therapy (time frame: Day 1 through Week 26). 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 4 Apr 2022.