Efficacy and Safety Study of Antibiotic Treatment to Treat Hip Prosthetic Joint Infection

Summary

The purpose of this study is to evaluate the efficacy of oral linezolid-rifampin combination therapy (over 4 or 6 weeks) versus the standard of care in the treatment of Gram-positive prosthetic hip joint infection with a one-stage surgical treatment.

Conditions

• Hip Prosthetic Joint Infection

Interventions

DRUG

VANCOMYCIN

DRUG

CEFTRIAXONE

DRUG

CLINDAMYCIN

DRUG

SULFAMETHOXAZOLE AND TRIMETHOPRIM (CO-TRIMOXAZOLE)

DRUG

FLUOROQUINOLONE

DRUG

LINEZOLID

DRUG

RIFAMPIN

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• International Clinical Trials Association

  collaborator OTHER

• University Hospital, Tours

  lead OTHER

Principal Investigators

• Louis BERNARD · CHRU de Tours FRANCE

• David BOUTOILLE · CHU de Nantes FRANCE

• Gwenael LE MOAL · CHU de Poitiers FRANCE

• Matteo BASSETTI · Azienda Opedaliera Universitaria San Maria della Misericordia ITALY

• Silvano ESPOSITO · Facolta di Medicina e Chirugia ITALY

• Jeannot GAUDIAS · Centre de Chirurgie Orthopédique et de la Main FRANCE

• Alex SORIANO · Hospital Clinic of Barcelona SPAIN

• Bartolome LLADO FERRER · Hospital Son Llatzer Palma Balears SPAIN

• Mar SANCHEZ SOMOLINOS · HGU Gregorio Maranon Madrid SPAIN

• Eric SENNEVILLE · CH de Tourcoing FRANCE

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• France
• Italy
• Spain

Study Locations