Prosthesis-related InfectionsPhase 3DATIPONCT01816009
Treatment of the Infections on Osteo-articular Prostheses by 6 Versus 12 Weeks of Antibiotherapy
A Phase 3 study testing duration of antibiotic treatment in people with Prosthesis-related Infections, run by University Hospital, Tours at 37 sites in France.
Trial summary
The study is a prospective, open randomized, non-inferiority trial with two parallel groups, comparing 6 weeks versus 12 weeks of antibiotic treatment following surgery procedure (debridement and retention, 1-stage or 2 stage exchange). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Prosthesis-related Infections
- What is being tested?
- duration of antibiotic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 37 sitesFrance
- Study dates
- Nov 2011to 21 Jan 2017
- Phase
- Phase 3
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women over 18, presenting at least one of the following clinical signs: pain, fever, dent or flow of scar
- Bacterial infection on osteo-articular prosthesis (hip or knee)
- Documented basterial infection
- Surgical care optimized with prothesis change or articular washing
- Infection requiring an antibiotic treatment by parenteral way Intravenous injection or per bone
- Treatment effective antibiotic begun in the most previously 21 days
- Signed consent
Who cannot join
- Patient with no proof of osteo-articular infection
- No surgical care
- Patient having more than one prothesis change because of sepsis
- Infection due to mycobactery, fungic infection or brucellienne infection
- Patient with life expectancy supposed lower than 2 years
- Guardianship patient
- Patient included in another study
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
France37 sites
Service de chirurgie orthopédique et traumatologique, CHU d'AMIENS
Amiens
Service des maladies infectieuses et tropicales, CHU d'ANGERS
Angers
Département de Médecine Interne et Maladies Infectieuses, hôpital privé d'Antony
Antony, 92160
Service des maladies infectieuses et tropicales, CHU de BESANCON
Besançon
Service de médecine interne, CH de BEZIERS
Béziers
Service de chirurgie orthopédique et traumatologique, Polyclinique de BLOIS
Blois
Service de Maladies Infectieuses et de Médecine Tropicale, Hôpital Pellegrin, CHU de Bordeaux
Bordeaux, 33076
Service de chirurgie orthopédique et traumatologique, CH de BOURG EN BRESSE
Bourg-en-Bresse
Service de Maladies Infectieuses, CH de BOURG EN BRESSE
Bourg-en-Bresse
Service de médecine interne et de maladies infectieuses, CHU de BREST
Brest
Service des maladies infectieuses et tropicales, CHU de CAEN
Caen
Service de médecine interne, rhumatologie, Centre Hospitalier Chalon sur Saône William Morey
Châlon Sur Saone, 71100
Service des maladies infectieuses et tropicales - médecine interne, CH de CHAMBERY
Chambéry
Service de Chirurgie Orthopédique et Traumatologique, APHP Hôpital Antoine Béclère
Clamart
Service de Médecine Interne et Immunologie Clinique, APHP Hôpital Antoine Béclère
Clamart
Service des maladies infectieuses et tropicales, CH de CLERMONT-FERRAND
Clermont-Ferrand
Centre de chirurgie orthopédique et de la main, CHRU de STRASBOURG
Illkirch-Graffenstaden
Unité de Traumatologie -Orthopédie septique, CHRU de LILLE
Lille
Service de Maladies Infectieuses, CHU de LIMOGES
Limoges
Centre de vaccinations internationales et de médecine des voyages du Tonkin
Lyon, 69100
Service des Maladies Infectieuses et tropicales, CHU de MONTPELLIER
Montpellier
Service des Maladies Infectieuses et tropicales, CHU de NANCY
Nancy
Service des maladies infectieuses et tropicales Hôtel-Dieu, CHU de Nantes
Nantes, 44093
Service de Chirurgie orthopédique Hôpital Lariboisière
Paris
Service des maladies infectieuses et tropicales CH Saint-Jean
Perpignan
Service de médecine interne, maladies infections et tropicales, CHU de POITIERS
Poitiers
Service de médecine interne, PONTOISE
Pontoise
Service des maldies infectieuses, CH d'ANNECY
Pringy
Service de Maladies Infectieuses, CHU de REIMS
Reims
Service des Maladies Infectieuses, CHU de RENNES
Rennes
Service de pneumologie - maladies infectieuses et tropicales, CH de ST QUENTIN
Saint-Quentin
Service d'infectiologie, CH de TOULON
Toulon
Service de Chirurgie Orthopédique et Traumatologique
Toulouse
Service des maladies infectieuses CH Gustave Dron
Tourcoing
Service de Chirurgie Orthopédique et traumatologie, hôpital Trousseau
Tours
Service de Médecine Interne et de Maladies Infectieuses, CHRU de TOURS
Tours
Service de chirurgie orthopédique, CH de VERSAILLES
Versailles
About this study
Official title: Multicentric Study, of Non Inferiority, Randomized, Opened, to Evaluate the Two Durations Effectiveness of Antibiotherapy (6 Weeks Versus 12 Weeks) in the Treatment of Osteo-articular Prostheses Infections, With Prosthetic Change (in 1 Time or 2 Long Times) or Not (Articular Washing)
The study is a prospective, open randomized, non-inferiority trial with two parallel groups, comparing 6 weeks versus 12 weeks of antibiotic treatment following surgery procedure (debridement and retention, 1-stage or 2 stage exchange).
The duration of the treatment antibiotic of prosthetic joint infections is only based on experts' opinion ; this one varies from 6 weeks to several months according to the customs of the influencer.
Read more
The principal aim of this study is to explore the efficacy and safety of 6 weeks versus 12 weeks antibiotic therapy duration, both associated with surgical procedure (debridement and retention of implant, one-stage or two stages exchange), in PJI treatment.
The study concerns 410 men or women of more than 18 years include in 34 centres in France.
The duration of the study is of 4 years.
Read the detailed description
Although the infection risk following primary hip and knee arthroplasties is less than 2%, prosthetic joint infections (PJI) have become more frequent due to the increasing number of patients undergoing surgery. PJI remains one of the most serious complications of prosthetic joint implantation. Each PJI episode represents substantial morbidity with a 5.3-7.2-fold higher cost than for the initial arthroplasty. The management of PJI almost always necessitates the need for surgical intervention and prolonged courses of intravenous or oral antimicrobial therapy. Despite a significant amount of basic and clinical research in this field, many questions pertaining to the definition of infection as well as diagnosis and management of these infections remain unanswered. The optimal surgical and antibiotic treatment of PJI remains unclear. The infection of implant is difficult to treat. According to the Infectious Diseases Society America recommendations of Osmon et al. in 2012, antibiotic therapy duration varies: 3 months for hip arthroplasties (6 months for total knee arthroplasties) for PJI with arthroplasty retention, and 6 weeks for two-stage exchanges.
Sometimes, excessive antibiotic treatment durations are performed because recommendations are not evidence-based sensu strictu and only based on experts' opinion. Short therapy should be benefit to ecologic and economic impact.
While the usual treatment is by the parenteral route for the first 2-4 weeks, this attitude is not evidence-based either. Up to one-third of patients with PJI may experience antibiotic-related or catheter-related problems during parenteral treatment. The one-stage and two-stage exchange of the infected implant has rather comparable success rate in the surgical management of the PJI (about 90%). Recent no-randomized studies indicate that short antibiotic therapy (6 weeks) seems to be efficient.
Our proposal study is to explore the efficacy and safety of 6 weeks in the treatment of PJI, after a surgical procedure.
The principal aim of this study is to explore the efficacy and safety of 6 weeks versus 12 weeks antibiotic therapy duration, both associated with surgical procedure (debridement and retention of implant, one-stage or two stages exchange), in PJI treatment.
Treatments antibiotics are chosen according to the germ and according to the consensual recommendations. Used antibiotics already have the AMM in this indication.
Eligible patients have at least one symptom relating to the PJI (such pain, sinus tract, inflammatory surgical scar…) and microbiological documentation of PJI.The primary endpoint is the occurrence of clinical cure at month 24. Secondary endpoints are (i) adequate clinical and biological response at months 6 and 12, (ii) incidence of adverse events in the two groups, (iii) oral and/or intravenous antibiotic therapy efficacy.
Randomization is stratified by the anatomical location of the infected joint (hip or knee) and surgical procedure (debridement and retention, 1-stage or 2 stage exchange).
The follow-up consists on periodic clinical examinations, anamnesis and occasionally laboratory or radiological controls.
- Conditions
- Prosthesis-related Infections
- Being tested
- duration of antibiotic treatment
- Keywords
- infection, antibiotic, prosthesis
- Medical subject headings
- Prosthesis-Related Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duration of antibiotic treatmentOther
Used antibiotics already have the AMM in this indication
| Study group | Role | What they receive |
|---|---|---|
| 6 weeks | Experimental | the duration of antibiotic treatment will be six weeks. Receives: Other: duration of antibiotic treatment |
| 12 weeks | Active comparator | the duration of antibiotic treatment will be 12 weeks. Receives: Other: duration of antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of clinical cure
Percentage of success in 2 years defined by the absence of infection or relapse in the same germ, and the absence of clinical, biological and radiological signs some of infection (pain, fever). This criterion will be estimated beyond the first 6 weeks of treatment antibiotic after the introduction of the treatment and until 2 years after the stop of the treatment.
Measured: two years
Secondary outcomes (1)
microbiological success
negativity of the microbiological samples during second step of 2 stage exchange (in the case of two-stage exchange of the implant).
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 posted21 Mar 2013 (estimated)
- Study startNov 2011
- Primary completion21 Jan 2017
- Study completion21 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prosthesis-related InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816009
- Sponsor's protocol ID
- PHRN09 - LB / DATIPO
- Other IDs
- 2010-021242-22, A101472-32
- Acronym
- DATIPO
- Status last verified
- Oct 2017
- First submitted
- 12 Mar 2013
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Bernard L, Arvieux C, Brunschweiler B, Touchais S, Ansart S, Bru JP, Oziol E, Boeri C, Gras G, Druon J, Rosset P, Senneville E, Bentayeb H, Bouhour D, Le Moal G, Michon J, Aumaitre H, Forestier E, Laffosse JM, Begue T, Chirouze C, Dauchy FA, Devaud E, Martha B, Burgot D, Boutoille D, Stindel E, Dinh A, Bemer P, Giraudeau B, Issartel B, Caille A. Antibiotic Therapy for 6 or 12 Weeks for Prosthetic Joint Infection. N Engl J Med. 2021 May 27;384(21):1991-2001. doi: 10.1056/NEJMoa2020198.
PubMed 34042388
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study, of Non Inferiority, Randomized, Opened, to Evaluate the Two Durations Effectiveness of Antibiotherapy (6 Weeks Versus 12 Weeks) in the Treatment of Osteo-articular Prostheses Infections, With Prosthetic Change (in 1 Time or 2 Long Times) or Not (Articular Washing)
- ClinicalTrials.gov ID
- NCT01816009
- Acronym / sponsor ID
- DATIPO / PHRN09 - LB / DATIPO
- Conditions
- Prosthesis-related Infections
- Keywords
- infection, antibiotic, prosthesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- 21 Jan 2017 (actual)
- Study completion
- 21 Jan 2017 (actual)
- First posted
- 21 Mar 2013 (estimated)
- 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.
The study is a prospective, open randomized, non-inferiority trial with two parallel groups, comparing 6 weeks versus 12 weeks of antibiotic treatment following surgery procedure (debridement and retention, 1-stage or 2 stage exchange).
The duration of the treatment antibiotic of prosthetic joint infections is only based on experts' opinion ; this one varies from 6 weeks to several months according to the customs of the influencer.
The principal aim of this study is to explore the efficacy and safety of 6 weeks versus 12 weeks antibiotic therapy duration, both associated with surgical procedure (debridement and retention of implant, one-stage or two stages exchange), in PJI treatment.
The study concerns 410 men or women of more than 18 years include in 34 centres in France.
The duration of the study is of 4 years.
Detailed description
Although the infection risk following primary hip and knee arthroplasties is less than 2%, prosthetic joint infections (PJI) have become more frequent due to the increasing number of patients undergoing surgery. PJI remains one of the most serious complications of prosthetic joint implantation. Each PJI episode represents substantial morbidity with a 5.3-7.2-fold higher cost than for the initial arthroplasty. The management of PJI almost always necessitates the need for surgical intervention and prolonged courses of intravenous or oral antimicrobial therapy. Despite a significant amount of basic and clinical research in this field, many questions pertaining to the definition of infection as well as diagnosis and management of these infections remain unanswered. The optimal surgical and antibiotic treatment of PJI remains unclear. The infection of implant is difficult to treat. According to the Infectious Diseases Society America recommendations of Osmon et al. in 2012, antibiotic therapy duration varies: 3 months for hip arthroplasties (6 months for total knee arthroplasties) for PJI with arthroplasty retention, and 6 weeks for two-stage exchanges.
Sometimes, excessive antibiotic treatment durations are performed because recommendations are not evidence-based sensu strictu and only based on experts' opinion. Short therapy should be benefit to ecologic and economic impact.
While the usual treatment is by the parenteral route for the first 2-4 weeks, this attitude is not evidence-based either. Up to one-third of patients with PJI may experience antibiotic-related or catheter-related problems during parenteral treatment. The one-stage and two-stage exchange of the infected implant has rather comparable success rate in the surgical management of the PJI (about 90%). Recent no-randomized studies indicate that short antibiotic therapy (6 weeks) seems to be efficient.
Our proposal study is to explore the efficacy and safety of 6 weeks in the treatment of PJI, after a surgical procedure.
The principal aim of this study is to explore the efficacy and safety of 6 weeks versus 12 weeks antibiotic therapy duration, both associated with surgical procedure (debridement and retention of implant, one-stage or two stages exchange), in PJI treatment.
Treatments antibiotics are chosen according to the germ and according to the consensual recommendations. Used antibiotics already have the AMM in this indication.
Eligible patients have at least one symptom relating to the PJI (such pain, sinus tract, inflammatory surgical scar…) and microbiological documentation of PJI.The primary endpoint is the occurrence of clinical cure at month 24. Secondary endpoints are (i) adequate clinical and biological response at months 6 and 12, (ii) incidence of adverse events in the two groups, (iii) oral and/or intravenous antibiotic therapy efficacy.
Randomization is stratified by the anatomical location of the infected joint (hip or knee) and surgical procedure (debridement and retention, 1-stage or 2 stage exchange).
The follow-up consists on periodic clinical examinations, anamnesis and occasionally laboratory or radiological controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 weeks | Experimental | Other: duration of antibiotic treatmentthe duration of antibiotic treatment will be six weeks. |
| 12 weeks | Active comparator | Other: duration of antibiotic treatmentthe duration of antibiotic treatment will be 12 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women over 18, presenting at least one of the following clinical signs: pain, fever, dent or flow of scar
- Bacterial infection on osteo-articular prosthesis (hip or knee)
- Documented basterial infection
- Surgical care optimized with prothesis change or articular washing
- Infection requiring an antibiotic treatment by parenteral way Intravenous injection or per bone
Key exclusion criteria (7 listed)
- Patient with no proof of osteo-articular infection
- No surgical care
- Patient having more than one prothesis change because of sepsis
- Infection due to mycobactery, fungic infection or brucellienne infection
- Patient with life expectancy supposed lower than 2 years
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 |
|---|---|---|
| duration of antibiotic treatmentUsed antibiotics already have the AMM in this indication | Other | 12 weeks, 6 weeks |
Primary outcome
occurrence of clinical cure
Time frame: two years
Percentage of success in 2 years defined by the absence of infection or relapse in the same germ, and the absence of clinical, biological and radiological signs some of infection (pain, fever). This criterion will be estimated beyond the first 6 weeks of treatment antibiotic after the introduction of the treatment and until 2 years after the stop of the treatment.
1 secondary outcome
microbiological success
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Results publication: PubMed 34042388Bernard L, Arvieux C, Brunschweiler B, Touchais S, Ansart S, Bru JP, Oziol E, Boeri C, Gras G, Druon J, Rosset P, Senneville E, Bentayeb H, Bouhour D, Le Moal G, Michon J, Aumaitre H, Forestier E, Laffosse JM, Begue T, Chirouze C, Dauchy FA, Devaud E, Martha B, Burgot D, Boutoille D, Stindel E, Dinh A, Bemer P, Giraudeau B, Issartel B, Caille A. Antibiotic Therapy for 6 or 12 Weeks for Prosthetic Joint Infection. N Engl J Med. 2021 May 27;384(21):1991-2001. doi: 10.1056/NEJMoa2020198.
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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.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing duration of antibiotic treatment in people with Prosthesis-related Infections, run by University Hospital, Tours at 37 sites in France.
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 7 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: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
occurrence of clinical cure (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816009, which also lists 1 linked publication.
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 26 Dec 2025.