Joint InfectionPhase 3NCT04723940
Or v IV Antibiotics for Infection
A Phase 3 study testing Bactrim, Cefadroxil and Doxycycline Hcl in people with Joint Infection, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Management of periprosthetic joint infection (PJI) commonly includes 6 weeks of intravenous (IV) antibiotics after surgical treatment. However, there is little evidence to suggest that oral (PO) therapy results in worse outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Joint Infection
- What is being tested?
- Bactrim, Cefadroxil and Doxycycline Hcl
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 25 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged ≥ 18 years
- willing and able to give informed consent
- primary THA or TKA diagnosed with PJI based on International Consensus Meeting criteria
- A sinus communicating with the prosthesis OR
- Two positive cultures obtained from the prosthesis OR
- 3 of 5 criteria:
Show all 13Show fewer
- Elevated ESR (>30mm/hr) and CRP (>10mg/L)
- Elevated synovial leukocyte count (>3000 cells/µL) or change of ++ on leukocyte esterase strip
- Elevated synovial neutrophil percentage (>80%)
- One positive culture
- Positive histological analysis of periprosthetic tissue (>5 neutrophils per high power field in 5 high power fields x400)
- PJI treated by debridement and implant retention, or excision of the prosthetic joint (with or without planned reimplantation)
- received ≤ 7 days of IV therapy after an appropriate surgical intervention
Who cannot join
- Previously treated for native septic arthritis or PJI in the same joint
- S. aureus bacteremia on presentation or within the previous month
- clinical, histological or microbiological evidence of mycobacterial, fungal or parasitic etiology of the infection
- any other concomitant infection that, in the opinion of the clinician responsible for the patient, requires a prolonged course of IV antibiotic therapy (e.g. bacterial endocarditis, mediastinal infection, central nervous system infection)
- septic shock or systemic features that, in the opinion of the clinician responsible for the patient, requires a course of IV antibiotic therapy (the patient could be re-evaluated if these features resolved)
- an infection for which there are no suitable antibiotic choices to permit randomization between the two arms of the trial (e.g. when organisms are only sensitive to IV antibiotics or PO antibiotics)
- unlikely to comply with trial requirements following randomization in the opinion of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Oral vs Intravenous Antibiotics for Treatment of Periprosthetic Joint Infection
Management of periprosthetic joint infection (PJI) commonly includes 6 weeks of intravenous (IV) antibiotics after surgical treatment. However, there is little evidence to suggest that oral (PO) therapy results in worse outcomes. This study aims to determine whether or not PO antibiotics are non-inferior to IV antibiotics in treating PJI. The study is a multicenter, parallel-group, randomized (1 : 1), open-label, non-inferiority trial. The non-inferiority margin will be set at 10%. Adults with a clinical diagnosis of PJI according to the International Consensus Meeting (ICM) criteria who would ordinarily receive at least 6 weeks of antibiotics and have received ≤ 7 days of IV therapy from surgery will be included. A total of 308 participants will be centrally computer-randomized to PO or IV antibiotics to complete the first 6 weeks of therapy. Follow-on PO therapy will be permitted in either arm. The primary outcome is the proportion of participants experiencing treatment failure within 1 year. An associated cost-effectiveness evaluation including complications, resource utilization and quality-of-life data will be performed.
- Conditions
- Joint Infection
- Being tested
- Bactrim, Cefadroxil, Doxycycline Hcl, Clindamycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BactrimDrug
Bactrim will be given for 6 weeks to treat joint infection
CefadroxilDrug
Cefadroxil will be given for 6 weeks to treat joint infection
Doxycycline HclDrug
Doxycycline HCl will given for 6 weeks to treat joint infection
ClindamycinDrug
Clindamycin will given for 6 weeks to treat joint infection
| Study group | Role | What they receive |
|---|---|---|
| Oral Antibiotics | Active comparator | Participant will receive 6 weeks of oral antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor. Receives: Drug: Bactrim; Drug: Cefadroxil; Drug: Doxycycline Hcl; Drug: Clindamycin |
| Intravenous Antibiotics | Active comparator | Participant will receive 6 weeks of intravenous (IV) antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor. Receives: Drug: Bactrim; Drug: Cefadroxil; Drug: Doxycycline Hcl; Drug: Clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Postoperative Infections
The investigator will measure the incidence of postoperative infections in participants treated with oral antibiotics versus those treated with intravenous antibiotics
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start25 Jan 2021
- Primary completion25 Jan 2028 (estimated)
- Study completion25 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723940
- Sponsor's protocol ID
- JPAR 20D.1085
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral vs Intravenous Antibiotics for Treatment of Periprosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT04723940
- Acronym / sponsor ID
- JPAR 20D.1085
- Conditions
- Joint Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 25 Jan 2028 (estimated)
- Study completion
- 25 Jan 2028 (estimated)
- First posted
- 26 Jan 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.
Management of periprosthetic joint infection (PJI) commonly includes 6 weeks of intravenous (IV) antibiotics after surgical treatment. However, there is little evidence to suggest that oral (PO) therapy results in worse outcomes. This study aims to determine whether or not PO antibiotics are non-inferior to IV antibiotics in treating PJI. The study is a multicenter, parallel-group, randomized (1 : 1), open-label, non-inferiority trial. The non-inferiority margin will be set at 10%. Adults with a clinical diagnosis of PJI according to the International Consensus Meeting (ICM) criteria who would ordinarily receive at least 6 weeks of antibiotics and have received ≤ 7 days of IV therapy from surgery will be included. A total of 308 participants will be centrally computer-randomized to PO or IV antibiotics to complete the first 6 weeks of therapy. Follow-on PO therapy will be permitted in either arm. The primary outcome is the proportion of participants experiencing treatment failure within 1 year. An associated cost-effectiveness evaluation including complications, resource utilization and quality-of-life data will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Antibiotics | Active comparator | Drug: Bactrim, Drug: Cefadroxil, Drug: Doxycycline Hcl, Drug: ClindamycinParticipant will receive 6 weeks of oral antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor. |
| Intravenous Antibiotics | Active comparator | Drug: Bactrim, Drug: Cefadroxil, Drug: Doxycycline Hcl, Drug: ClindamycinParticipant will receive 6 weeks of intravenous (IV) antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- aged ≥ 18 years
- willing and able to give informed consent
- primary THA or TKA diagnosed with PJI based on International Consensus Meeting criteria
- Elevated ESR (>30mm/hr) and CRP (>10mg/L)
- Elevated synovial leukocyte count (>3000 cells/µL) or change of ++ on leukocyte esterase strip
Key exclusion criteria (7 listed)
- Previously treated for native septic arthritis or PJI in the same joint
- S. aureus bacteremia on presentation or within the previous month
- clinical, histological or microbiological evidence of mycobacterial, fungal or parasitic etiology of the infection
- any other concomitant infection that, in the opinion of the clinician responsible for the patient, requires a prolonged course of IV antibiotic therapy (e.g. bacterial endocarditis, mediastinal infection, central nervous system infection)
- septic shock or systemic features that, in the opinion of the clinician responsible for the patient, requires a course of IV antibiotic therapy (the patient could be re-evaluated if these features resolved)
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 |
|---|---|---|
| BactrimBactrim will be given for 6 weeks to treat joint infection | Drug | Intravenous Antibiotics, Oral Antibiotics |
| CefadroxilCefadroxil will be given for 6 weeks to treat joint infection | Drug | Intravenous Antibiotics, Oral Antibiotics |
| Doxycycline HclDoxycycline HCl will given for 6 weeks to treat joint infection | Drug | Intravenous Antibiotics, Oral Antibiotics |
| ClindamycinClindamycin will given for 6 weeks to treat joint infection | Drug | Intravenous Antibiotics, Oral Antibiotics |
Primary outcome
Rate of Postoperative Infections
Time frame: 2 years
The investigator will measure the incidence of postoperative infections in participants treated with oral antibiotics versus those treated with intravenous antibiotics
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bactrim, Cefadroxil and Doxycycline Hcl in people with Joint Infection, run by Rothman Institute Orthopaedics 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?
The sponsor lists 13 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 8 Oct 2026. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Rate of Postoperative Infections (time frame: 2 years). 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 Oct 2026.