Role of rifampin for treatment of orthopedic implant-related staphylococcal infections: a randomized controlled trial. Foreign-Body Infection (FBI) Study Group.
BACKGROUND
Rifampin-containing regimens are able to cure staphylococcal implant-related infections based on in vitro and in vivo observations. However, this evidence has not been proven by a controlled clinical trial.


OBJECTIVE
To evaluate the clinical efficacy of a rifampin combination in staphylococcal infections associated with stable orthopedic devices.


METHODS
A randomized, placebo-controlled, double-blind trial conducted from 1992 through 1997.


METHODS
Two infectious disease services in tertiary care centers in collaboration with 5 orthopedic surgeons in Switzerland.


METHODS
A total of 33 patients with culture-proven staphylococcal infection associated with stable orthopedic implants and with a short duration of symptoms of infection (exclusion limit <1 year; actual experience 0-21 days).


METHODS
Initial debridement and 2-week intravenous course of flucloxacillin or vancomycin with rifampin or placebo, followed by either ciprofloxacin-rifampin or ciprofloxacin-placebo long-term therapy.


METHODS
Cure was defined as (1) lack of clinical signs and symptoms of infection, (2) C-reactive protein level less than 5 mg/L, and (3) absence of radiological signs of loosening or infection at the final follow-up visit at 24 months. Failure was defined as (1) persisting clinical and/or laboratory signs of infection or (2) persisting or new isolation of the initial microorganism.


RESULTS
A total of 18 patients were allocated to ciprofloxacin-rifampin and 15 patients to the ciprofloxacin-placebo combination. Twenty-four patients fully completed the trial with a follow-up of 35 and 33 months. The cure rate was 12 (100%) of 12 in the ciprofloxacin-rifampin group compared with 7 (58%) of 12 in the ciprofloxacin-placebo group (P=.02). Nine of 33 patients dropped out due to adverse events (n=6), noncompliance (n=1), or protocol violation (n=2). Seven of the 9 patients who dropped out were subsequently treated with rifampin combinations, and 5 of them were cured without removal of the device.


CONCLUSIONS
Among patients with stable implants, short duration of infection, and initial debridement, patients able to tolerate long-term (3-6 months) therapy with rifampin-ciprofloxacin experienced cure of the infection without removal of the implant.
Zimmerli
W
W
Department of Internal Medicine, University Hospitals, Basel, Switzerland. zimmerliw@ubaclu.unibas.ch
Widmer
A F
AF
Blatter
M
M
Frei
R
R
Ochsner
P E
PE
D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000627:therapeutic use; D000904:Antibiotics, Antitubercular / Q000627:therapeutic use*; D002939:Ciprofloxacin / Q000627:therapeutic use; D018572:Disease-Free Survival; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D005260:Female; D005436:Floxacillin / Q000627:therapeutic use; D006622:Hip Prosthesis / Q000009:adverse effects*; D006801:Humans; D007720:Knee Prosthesis / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009984:Orthopedic Fixation Devices / Q000009:adverse effects*; D010406:Penicillins / Q000627:therapeutic use; D016459:Prosthesis-Related Infections / Q000188:drug therapy*; D012293:Rifampin / Q000627:therapeutic use*; D013203:Staphylococcal Infections / Q000188:drug therapy*; D016896:Treatment Outcome; D014640:Vancomycin / Q000627:therapeutic use
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D000904:Antibiotics, Antitubercular; D010406:Penicillins; D005436:Floxacillin; D002939:Ciprofloxacin; D014640:Vancomycin; D012293:Rifampin