Daptomycin use in patients with osteomyelitis: a preliminary report from the EU-CORESM database (original) (raw)
Related papers
Clinical Experience with Daptomycin for the Treatment of Patients with Osteomyelitis
The American Journal of Medicine, 2007
Data from a registry were analyzed to describe the clinical experience with daptomycin (Cubicin; Cubist Pharmaceuticals, Inc., Lexington, MA) for the treatment of patients with osteomyelitis. The Cubicin Outcomes Registry and Experience (CORE) 2004 database was used to identify patients treated for osteomyelitis. Posttherapy follow-up outcome assessments were collected for a subset of these patients. A total of 67 patients with osteomyelitis were clinically evaluable for outcome at the end of daptomycin therapy and had outcome assessed at a posttherapy visit. The median follow-up interval after the last dose of daptomycin was 76 days (range, 1 to 547 days). The median initial dose was 5.6 mg/kg (range, 3.2 to 7.5 mg/kg), and the median duration of therapy was 35 days (range, 3 to 546 days). Daptomycin was given concurrently with other antibiotics in 48% of cases. Methicillin-resistant Staphylococcus aureus was the most common pathogen (45%). Clinical outcomes at follow-up were cure, 42 (63%); improved, 13 (19%); failure, 7 (10%); and nonevaluable, 5 (7%). A total of 82% of patients with an orthopedic device (n = 17) were successfully treated, as were 88% of patients with concurrent bacteremia (n = 16). Failures were more likely if surgical debridement was not performed (24% vs. 5%; P = 0.045). The clinical success rate for patients treated with an initial daptomycin dose >4 mg/kg was significantly higher than for patients treated with an initial dose < or =4 mg/kg (88% vs. 65%; P = 0.013, chi2 test). Daptomycin had a 94% success rate when used alone with no follow-up antibiotics. The results indicate that daptomycin is being used in clinical practice to treat patients with osteomyelitis caused by gram-positive pathogens including MRSA. Prospective, controlled clinical trials of daptomycin are warranted that include rigorous data collection and long-term follow-up analysis.
Daptomycin Therapy for Osteomyelitis: A Retrospective Study
BMC Infectious Diseases, 2012
Background: Daptomycin is a rapidly bactericidal agent with broad coverage against Gram-positive organisms, including Staphylococcus aureus, the most frequent cause of osteomyelitis. The objective of this study was to describe the clinical outcome of patients with non-hardware associated osteomyelitis, and the safety profile of daptomycin in the treatment of these infections. Methods: All patients with osteomyelitis, excluding concurrent orthopedic foreign body infections, treated with daptomycin and identified between 2007-2008 in a retrospective, multicenter, observational registry, were included. Investigators assessed patient outcome (cured, improved, failed, non-evaluable) at the end of daptomycin therapy. Patients with a successful outcome at the end of daptomycin therapy were reassessed in 2009. All patients were included in the safety analysis; evaluable patients were included in the efficacy analysis. Data was assessed using descriptive statistics. A Kaplan Meier analysis was used to assess time to clinical failure.
Antimicrobial Agents and Chemotherapy, 2012
ABSTRACTThe prevalence ofStaphylococcus aureuscausing prosthetic joint infection (PJI) supports investigation of higher doses of daptomycin in the management of PJI. This was a prospective, randomized controlled trial studying safety and efficacy of daptomycin (6 and 8 mg/kg of body weight) compared with standard-of-care therapy for PJI. This open-label study randomized 75 patients undergoing 2-stage revision arthroplasty to daptomycin at 6 or 8 mg/kg or a comparator (vancomycin, teicoplanin, or semisynthetic penicillin). After prosthesis removal, patients received 6 weeks of antibiotic treatment and a 2- to 6-week antibiotic-free period before implantation of a new prosthesis. Test of cure (TOC) was within 1 to 2 weeks after reimplantation. The primary objective was evaluation of creatine phosphokinase (CPK) levels. Secondary objectives were clinical efficacy and microbiological assessments. Of 73 CPK safety population patients, CPK elevation of >500 U/liter occurred in 4 of 25 ...
Daptomycin treatment of Staphylococcus aureus experimental chronic osteomyelitis
2000
Background: Infection due to methicillin-resistant Staphylococcus aureus (MRSA) is increasingly common in nosocomial and community settings. Daptomycin is a cyclic lipopeptide anti-infective with activity against MRSA, approved for treatment of complicated skin and skin structure infections. Daptomycin may be useful in systemic or local treatment of chronic osteomyelitis. Methods: We measured mechanical strength of daptomycin- and vancomycin-loaded polymethylmethac- rylate (PMMA),
International Orthopaedics, 2013
Purpose Treatment of Gram-positive osteoarticular infections requires an adequate surgical approach combined with intensive antimicrobial therapy. The aim of this study was to evaluate the safety and efficacy of a combined regimen of high-dose daptomycin and rifampicin, in patients with various types of Gram-positive osteoarticular infections. Methods This single centre, non-comparative, prospective study evaluated the safety and efficacy of a combined regimen of intravenous daptomycin (8 mg/kg/day) and oral rifampicin (600 mg/day) in patients with Gram-positive osteoarticular infections, with a minimal follow-up of one year. Creatine phosphokinase, transaminases, bilirubinaemia, and serum creatinine, were measured at baseline and regular intervals. Results The median daily doses of daptomycin and rifampicin, administered for a median duration of 21 (range, 10-122) days to 16 patients (median age, 63.5 years; 11 males, five females) presenting with staphylococcal (n=15) or streptococcal (n=1) osteoarticular infections, were 8.15 (range, 6.6-8.9) mg/kg/day and 600 (range, 600-900) mg/day, respectively. The combined regimen of daptomycin and rifampicin was well tolerated by all except one patient, without requiring treatment adjustment or discontinuation. One patient developed allergic responses probably due to rifampicin after 42 days. Fifteen (94 %) patients showed favourable clinical and microbiological outcomes. Conclusions The combined regimen of high-dose daptomycin and rifampicin was well tolerated and may provide a useful alternative to standard glycopeptide therapy for Gram-positive osteoarticular infections.
Antibiotics
Vertebral osteomyelitis (VO) is a compelling clinical entity for clinicians, because of its insidious and indolent course that makes diagnosis difficult. A concern is reported about the choice of antibiotic regimens, duration of therapy, and criteria to switch to oral therapy. We conducted a prospective observational study. All consecutive hospitalized patients with a confirmed diagnosis of VO caused by staphylococcal or enterococcal strains were analyzed. The primary endpoint was the analysis of clinical cure at the end of therapy. A propensity score for receiving therapy with daptomycin was added to the model. During the study period, 60 episodes of confirmed VO were observed. The main etiology of infection was methicillin-resistant Staphylococcus aureus (29%). Overall, clinical failure at end of therapy was reported in 11 (18.3%) patients. Logistic regression analysis, after propensity score, showed that >2 vertebrae involved (OR 2.4, CI95% 1.12–5.24, p = 0.002) and inadequate...
Open Forum Infectious Diseases
Background Osteomyelitis is a challenging infection that can involve 4–6 weeks of intravenous (IV) antibiotics. Dalbavancin, approved for acute bacterial skin and skin structure infections, has potent activity against gram-positive pathogens. This study assessed the efficacy and safety of dalbavancin as a 2-dose regimen for osteomyelitis. Methods This study was a randomized, open-label, comparator-controlled trial in adults with a first episode of osteomyelitis defined by clinical symptoms, radiologic findings, and elevated C-reactive protein. Patients were randomized 7:1 to dalbavancin (1500 mg IV on days 1 and 8) or standard of care (SOC) for osteomyelitis (oral or IV) per investigator judgment for 4–6 weeks. The primary endpoint was clinical response at day 42, defined as recovery without need for additional antibiotics in the clinically evaluable (CE) population. Clinical response was also assessed at day 21, 6 months, and 1 year. Results Eighty patients were randomized to dalba...