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CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RESEARCH SUPPORT, NON-U.S. GOV'T
Brief communication: treatment of Enterococcus faecalis endocarditis with ampicillin plus ceftriaxone.
Annals of Internal Medicine 2007 April 18
BACKGROUND: High-level aminoglycoside resistance (HLAR) that precludes bactericidal synergism with penicillins or glycopeptides and nephrotoxicity related to aminoglycoside treatment are major problems in treating Enterococcus faecalis endocarditis.
OBJECTIVE: To evaluate the efficacy and safety of ampicillin plus ceftriaxone for treating endocarditis due to E. faecalis with and without HLAR.
DESIGN: Observational, open-label, nonrandomized, multicenter clinical trial.
SETTING: 13 centers in Spain.
PATIENTS: 21 patients with HLAR E. faecalis endocarditis and 22 patients with non-HLAR E. faecalis endocarditis. All were at risk for nephrotoxicity related to aminoglycoside use.
INTERVENTION: 6-week course of intravenous ampicillin, 2 g every 4 hours, plus intravenous ceftriaxone, 2 g every 12 hours.
MEASUREMENTS: Clinical and microbiological outcomes.
RESULTS: The clinical cure rate at 3 months was 67.4% (29 of 43 patients) among all episodes. During treatment, 28.6% of patients with HLAR E. faecalis endocarditis and 18.2% of patients with non-HLAR E. faecalis endocarditis died of infection-related causes. The rate of clinical and microbiological cure in patients who completed the protocol was 100% in the HLAR E. faecalis endocarditis group. No episodes of breakthrough bacteremia occurred, although there were 2 relapses in the non-HLAR E. faecalis endocarditis group. Treatment was withdrawn in 1 case because of fever and skin rash.
LIMITATIONS: The study had a small sample and was observational.
CONCLUSION: The combination of ampicillin and ceftriaxone is effective and safe for treating HLAR E. faecalis endocarditis and could be a reasonable alternative for patients with non-HLAR E. faecalis endocarditis who are at increased risk for nephrotoxicity.
OBJECTIVE: To evaluate the efficacy and safety of ampicillin plus ceftriaxone for treating endocarditis due to E. faecalis with and without HLAR.
DESIGN: Observational, open-label, nonrandomized, multicenter clinical trial.
SETTING: 13 centers in Spain.
PATIENTS: 21 patients with HLAR E. faecalis endocarditis and 22 patients with non-HLAR E. faecalis endocarditis. All were at risk for nephrotoxicity related to aminoglycoside use.
INTERVENTION: 6-week course of intravenous ampicillin, 2 g every 4 hours, plus intravenous ceftriaxone, 2 g every 12 hours.
MEASUREMENTS: Clinical and microbiological outcomes.
RESULTS: The clinical cure rate at 3 months was 67.4% (29 of 43 patients) among all episodes. During treatment, 28.6% of patients with HLAR E. faecalis endocarditis and 18.2% of patients with non-HLAR E. faecalis endocarditis died of infection-related causes. The rate of clinical and microbiological cure in patients who completed the protocol was 100% in the HLAR E. faecalis endocarditis group. No episodes of breakthrough bacteremia occurred, although there were 2 relapses in the non-HLAR E. faecalis endocarditis group. Treatment was withdrawn in 1 case because of fever and skin rash.
LIMITATIONS: The study had a small sample and was observational.
CONCLUSION: The combination of ampicillin and ceftriaxone is effective and safe for treating HLAR E. faecalis endocarditis and could be a reasonable alternative for patients with non-HLAR E. faecalis endocarditis who are at increased risk for nephrotoxicity.
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