ISRCTN35285839已完成不适用

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 infection: a phase IV, multicentre, open trial

niversity Hospital of Bellvitge (Hospital Universitario de Bellvitge) (Spain)0 个研究点目标入组 195 人开始时间: 2011年8月4日最近更新: 2015年1月13日

适应症

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•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.

•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

发起方

niversity Hospital of Bellvitge (Hospital Universitario de Bellvitge) (Spain)