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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

Tracking Information
First Submitted Date  ICMJE March 12, 2013
First Posted Date  ICMJE March 21, 2013
Last Update Posted Date November 1, 2017
Actual Study Start Date  ICMJE November 2011
Actual Primary Completion Date January 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01816009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2013)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of the Infections on Osteo-articular Prostheses by 6 Versus 12 Weeks of Antibiotherapy
Official Title  ICMJE 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)
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prosthesis-related Infections
Intervention  ICMJE Other: duration of antibiotic treatment
Used antibiotics already have the AMM in this indication
Study Arms  ICMJE
  • Experimental: 6 weeks
    the duration of antibiotic treatment will be six weeks.
    Intervention: Other: duration of antibiotic treatment
  • Active Comparator: 12 weeks
    the duration of antibiotic treatment will be 12 weeks.
    Intervention: Other: duration of antibiotic treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2013)
410
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 21, 2017
Actual Primary Completion Date January 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01816009
Other Study ID Numbers  ICMJE PHRN09 - LB / DATIPO
2010-021242-22 ( EudraCT Number )
A101472-32 ( Other Identifier: AFSSAPS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Tours
Study Sponsor  ICMJE University Hospital, Tours
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Tours
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP