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Treatment of the Infections on Osteo-articular Prostheses by 6 Versus 12 Weeks of Antibiotherapy (DATIPO)

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ClinicalTrials.gov Identifier: NCT01816009
Recruitment Status : Completed
First Posted : March 21, 2013
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief 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).

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.


Condition or disease Intervention/treatment Phase
Prosthesis-related Infections Other: duration of antibiotic treatment Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 2011
Actual Primary Completion Date : January 21, 2017
Actual Study Completion Date : January 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 6 weeks
the duration of antibiotic treatment will be six weeks.
Other: duration of antibiotic treatment
Used antibiotics already have the AMM in this indication

Active Comparator: 12 weeks
the duration of antibiotic treatment will be 12 weeks.
Other: duration of antibiotic treatment
Used antibiotics already have the AMM in this indication




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. microbiological success [ Time Frame: 2 years ]
    negativity of the microbiological samples during second step of 2 stage exchange (in the case of two-stage exchange of the implant).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816009


Locations
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France
Service de chirurgie orthopédique et traumatologique, CHU d'AMIENS
Amiens, France
Service des maladies infectieuses et tropicales, CHU d'ANGERS
Angers, France
Département de Médecine Interne et Maladies Infectieuses, hôpital privé d'Antony
Antony, France, 92160
Service des maladies infectieuses et tropicales, CHU de BESANCON
Besançon, France
Service de médecine interne, CH de BEZIERS
Beziers, France
Service de chirurgie orthopédique et traumatologique, Polyclinique de BLOIS
Blois, France
Service de Maladies Infectieuses et de Médecine Tropicale, Hôpital Pellegrin, CHU de Bordeaux
Bordeaux, France, 33076
Service de chirurgie orthopédique et traumatologique, CH de BOURG EN BRESSE
Bourg-en-Bresse, France
Service de Maladies Infectieuses, CH de BOURG EN BRESSE
Bourg-en-Bresse, France
Service de médecine interne et de maladies infectieuses, CHU de BREST
Brest, France
Service des maladies infectieuses et tropicales, CHU de CAEN
Caen, France
Service des maladies infectieuses et tropicales - médecine interne, CH de CHAMBERY
Chambery, France
Service de médecine interne, rhumatologie, Centre Hospitalier Chalon sur Saône William Morey
Châlon sur Saone, France, 71100
Service de Chirurgie Orthopédique et Traumatologique, APHP Hôpital Antoine Béclère
Clamart, France
Service de Médecine Interne et Immunologie Clinique, APHP Hôpital Antoine Béclère
Clamart, France
Service des maladies infectieuses et tropicales, CH de CLERMONT-FERRAND
Clermont Ferrand, France
Centre de chirurgie orthopédique et de la main, CHRU de STRASBOURG
Illkirch GRAFFENSTADEN, France
Unité de Traumatologie -Orthopédie septique, CHRU de LILLE
Lille, France
Service de Maladies Infectieuses, CHU de LIMOGES
Limoges, France
Centre de vaccinations internationales et de médecine des voyages du Tonkin
Lyon, France, 69100
Service des Maladies Infectieuses et tropicales, CHU de MONTPELLIER
Montpellier, France
Service des Maladies Infectieuses et tropicales, CHU de NANCY
Nancy, France
Service des maladies infectieuses et tropicales Hôtel-Dieu, CHU de Nantes
Nantes, France, 44093
Service de Chirurgie orthopédique Hôpital Lariboisière
Paris, France
Service des maladies infectieuses et tropicales CH Saint-Jean
Perpignan, France
Service de médecine interne, maladies infections et tropicales, CHU de POITIERS
Poitiers, France
Service de médecine interne, PONTOISE
Pontoise, France
Service des maldies infectieuses, CH d'ANNECY
Pringy, France
Service de Maladies Infectieuses, CHU de REIMS
Reims, France
Service des Maladies Infectieuses, CHU de RENNES
Rennes, France
Service de pneumologie - maladies infectieuses et tropicales, CH de ST QUENTIN
Saint Quentin, France
Service d'infectiologie, CH de TOULON
Toulon, France
Service de Chirurgie Orthopédique et Traumatologique
Toulouse, France
Service des maladies infectieuses CH Gustave Dron
Tourcoing, France
Service de Chirurgie Orthopédique et traumatologie, hôpital Trousseau
Tours, France
Service de Médecine Interne et de Maladies Infectieuses, CHRU de TOURS
Tours, France
Service de chirurgie orthopédique, CH de VERSAILLES
Versailles, France
Sponsors and Collaborators
University Hospital, Tours

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01816009     History of Changes
Other Study ID Numbers: PHRN09 - LB / DATIPO
2010-021242-22 ( EudraCT Number )
A101472-32 ( Other Identifier: AFSSAPS )
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

Keywords provided by University Hospital, Tours:
infection
antibiotic
prosthesis

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Prosthesis-Related Infections
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents