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

Prosthesis-related Infections Clinical Trial

— DATIPO  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816009
• Other study ID #: PHRN09 - LB / DATIPO
• Secondary ID: 2010-021242-22A1
• Status: Completed
• Phase: Phase 3
• First received: March 12, 2013
• Last updated: October 30, 2017
• Start date: November 2011
• Est. completion date: January 21, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: January 21, 2017
• Est. primary completion date: January 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Prosthesis-related Infections

Intervention

Other:
• duration of antibiotic treatment
Used antibiotics already have the AMM in this indication

Locations

Country	Name	City	State
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	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	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 de médecine interne, rhumatologie, Centre Hospitalier Chalon sur Saône William Morey	Châlon sur Saone
France	Service des maladies infectieuses et tropicales - médecine interne, CH de CHAMBERY	Chambery
France	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	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	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	two years
Secondary	microbiological success	negativity of the microbiological samples during second step of 2 stage exchange (in the case of two-stage exchange of the implant).	2 years