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Zimmerli W, Widmer AF, Blatter M, Frei R, Ochsner PE, for the Foreign-Body Infection (FBI) Study Group. Role of Rifampin for Treatment of Orthopedic Implant–Related Staphylococcal Infections : A Randomized Controlled Trial. JAMA. 1998;279(19):1537–1541. doi:10.1001/jama.279.19.1537
From the Division of Infectious Diseases, Department of Internal Medicine (Drs Zimmerli and Blatter), Division of Clinical Epidemiology (Dr Widmer), and Bacteriology Laboratory (Dr Frei), University Hospitals, Basel, Switzerland; and Clinic of Orthopedic Surgery, Kantonsspital, Liestal, Switzerland (Dr Ochsner).
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.
To evaluate the clinical efficacy of a rifampin combination in staphylococcal
infections associated with stable orthopedic devices.
A randomized, placebo-controlled, double-blind trial conducted from
1992 through 1997.
Two infectious disease services in tertiary care centers in collaboration
with 5 orthopedic surgeons in Switzerland.
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).
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.
Main Outcome Measures.—
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.
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.
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.
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