Comparative study of the efficacy of short and long duration levofloxacin-rifampicin combination therapy in the treatment of early postoperative and haemotogenous staphylococcal prosthetic joint infectio

Completed

• Conditions: Prosthetic joint infection; Infections and Infestations

• Registration Number: ISRCTN35285839
• Lead Sponsor: niversity Hospital of Bellvitge (Hospital Universitario de Bellvitge) (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

1. Diagnosis of prosthesis joint infection: fever, local pain, inflammatory signs or purulent exudate in the surgical wound and/or purulent macroscopic exudate during the debridement surgery. Prosthesis joint infection will be considered early-postoperative if symptoms and signs begin in the first 30 days after the placement of the prosthesis. It will be considered haematogenous when the clinical picture is acute and/or it develops in the setting of bacteremia or concomitant to other distant infection.
2. Diagnosis of staphylococcal etiology: Staphylococcus sp must be isolated from reliable samples, such as blood cultures or purulent exudate obtained during surgery or by arthrocentesis. Polymicrobial cases will be accepted if it is not necessary to add more antibiotics with anti-staphylococcal activity to the oral combination of rifampicin and levofloxacin.

Exclusion Criteria

1. Age less than 18 years
2. Pregnancy or breastfeeding
3. Women who may become pregnant in whom methods of contraception cannot be guaranteed during the period of antibiotic therapy
4. Life-expectancy less than 6 months
5. Unwillingness to parcipate in the study or to give written-informed consent
6. Unwillingness to avoid the use of contact lenses during the period of antibiotic therapy
7. Reasonable doubts about the patient?s treatment observance
8. Allergy or intolerance to quinolones and/or rifampicin which lead to the antimicrobial(s) withdrawal. Prosthesis joint infection by quinolones and/or rifampicin resistance
9. Administration of antibiotics with anti-staphylococcal activity different from rifampicin or levofloxacin for more than 7 days, during the period of study or during the follow-up
10. Delay in performing the surgical debridement of the prosthesis infection of 21 or more days, counting from the beginning of symptoms and signs of infection
11. Radiographic signs of prosthesis loosening in simple X-ray
12. Prosthesis removal during surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of a treatment consisting in early surgical debridement and antimicrobial therapy with an oral combination of rifampin and levofloxacin during either 8 weeks (?Short? schedule group) or 3 (hip prosthesis) to 6 (knee prosthesis) months (?Long? schedule group; standard schedule), in the early-postoperative and haematogenous prosthesis joint infection of staphylococcal etiology (Staphylococcus aureus and Coagulase-negative Staphylococcus)