Prosthetic Joint InfectionNCT05247281
NGS vs Culture Outcomes for Treatment of PJI
A study testing Culture-based treatment and Next Generation Sequencing (NGS) with Culture in people with Prosthetic Joint Infection, run by Center for Innovation and Research Organization at 9 sites in United States.
Trial summary
This multicenter, randomized controlled trial will compare the use of NGS and traditional culture in directing antimicrobial treatment for patients with periprosthetic joint infection. 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?
- Culture-based treatment and Next Generation Sequencing (NGS) with Culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 Sep 2022to May 2025
- Phase
- Interventional
- 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
- Adults (age > 18 years)
- Undergoing single stage revision or 1st stage resection arthroplasty/spacer placement for PJI (ICM-positive) of the hip or knee
- Written informed consent
Who cannot join
- Ongoing participation in another clinical trial
- Megaprosthesis
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Cleveland Clinic Ohio
Cleveland, Ohio, 44195
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
University of Southern California
Los Angeles, California, 90033
Columbia University
New York, New York, 10032
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
University of Rochester
Rochester, New York, 14618
University of Utah
Salt Lake City, Utah, 84108
Northwell Health
Staten Island, New York, 10309
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official title: Randomized Controlled Trial Investigating the Use of Next-generation Sequencing in Directing the Antimicrobial Treatment of Periprosthetic Joint Infection
This multicenter, randomized controlled trial will compare the use of NGS and traditional culture in directing antimicrobial treatment for patients with periprosthetic joint infection.
- Conditions
- Prosthetic Joint Infection
- Being tested
- Culture-based treatment, Next Generation Sequencing (NGS) with Culture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culture-based treatmentDiagnostic test
Medications to treat prosthetic joint infection will be chosen based on results of traditional cultures alone
Next Generation Sequencing (NGS) with CultureDiagnostic test
Medications to treat prosthetic joint infection will be chosen based results of NGS and culture
| Study group | Role | What they receive |
|---|---|---|
| Culture-based treatment | Active comparator | Not described Receives: Diagnostic Test: Culture-based treatment |
| Next Generation Sequencing (NGS) with Culture-based treatment | Active comparator | Not described Receives: Diagnostic Test: Next Generation Sequencing (NGS) with Culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who have been diagnosed with prosthetic joint infection as assessed by the 2018 International Consensus Definition of prosthetic joint infection
Diagnosis of re-infection following surgery and treatment for prosthetic joint infection
Measured: 90 days from time of surgery
Secondary outcomes (1)
Number of subjects who have a re-operation as assessed by inpatient hospitalization medical records
Measured: one year from time to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start21 Sep 2022
- Primary completionMay 2024 (estimated)
- Study completionMay 2025 (estimated)
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Innovation and Research Organization
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Tiffany Morrison, Study director, Center for Innovation and Research Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247281
- Sponsor's protocol ID
- 2022NGSOutcomes
- Status last verified
- Oct 2023
- First submitted
- 13 Jan 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Investigating the Use of Next-generation Sequencing in Directing the Antimicrobial Treatment of Periprosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT05247281
- Acronym / sponsor ID
- 2022NGSOutcomes
- Conditions
- Prosthetic Joint Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Center for Innovation and Research OrganizationResearch network
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 18 Feb 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 multicenter, randomized controlled trial will compare the use of NGS and traditional culture in directing antimicrobial treatment for patients with periprosthetic joint infection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culture-based treatment | Active comparator | Diagnostic Test: Culture-based treatment |
| Next Generation Sequencing (NGS) with Culture-based treatment | Active comparator | Diagnostic Test: Next Generation Sequencing (NGS) with Culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (age > 18 years)
- Undergoing single stage revision or 1st stage resection arthroplasty/spacer placement for PJI (ICM-positive) of the hip or knee
- Written informed consent
Key exclusion criteria (2 listed)
- Ongoing participation in another clinical trial
- Megaprosthesis
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 |
|---|---|---|
| Culture-based treatmentMedications to treat prosthetic joint infection will be chosen based on results of traditional cultures alone | Diagnostic test | Culture-based treatment |
| Next Generation Sequencing (NGS) with CultureMedications to treat prosthetic joint infection will be chosen based results of NGS and culture | Diagnostic test | Next Generation Sequencing (NGS) with Culture-based treatment |
Primary outcome
Number of participants who have been diagnosed with prosthetic joint infection as assessed by the 2018 International Consensus Definition of prosthetic joint infection
Time frame: 90 days from time of surgery
Diagnosis of re-infection following surgery and treatment for prosthetic joint infection
1 secondary outcome
Number of subjects who have a re-operation as assessed by inpatient hospitalization medical records
Time frame: one year from time to surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
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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.
Tiffany Morrison study director
Center for Innovation and Research Organization
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culture-based treatment and Next Generation Sequencing (NGS) with Culture in people with Prosthetic Joint Infection, run by Center for Innovation and Research Organization at 9 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 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 9 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Number of participants who have been diagnosed with prosthetic joint infection as assessed by the 2018 International Consensus Definition of prosthetic joint infection (time frame: 90 days from time of surgery). 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 8 Nov 2023.