BACKGROUND:Linezolid is a novel oxazolidinone antibiotic that is effective for the treatment of gram-positive bacterial infections. The oral formulation has the potential to reduce length of stay (LOS) when used as a substitute for parenteral glycopeptide antibiotics. In a recent multinational trial comparing linezolid (i.v. followed by oral administration) with teicoplanin (i.v. alone or switched to i.m. administration), linezolid was found to have better efficacy (P = 0.005) and similar safety for treating serious gram-positive infections. OBJECTIVE: The purpose of this study was to compare hospital resource use (primarily LOS) and cost of treatment between linezolid and teicoplanin for hospitalized patients with serious gram-positive infections in South America and Mexico using data from the multinational trial. METHODS: In a multinational, Phase IIIb, open-label, comparator-controlled trial, data were collected from hospitalized patients in centers in 6 South America can countries and Mexico with suspected or confirmed serious gram-positive infections. Patients were randomly assigned to receive i.v. linezolid 600 mg BID (for the entire treatment period [7-28 days] or switched to oral linezolid 600 mg BID) or i.v. teicoplanin (for the entire treatment period or switched to i.m. teicoplanin) dosed per approved prescription information. Data on direct medical resource utilization were collected for each patient, including duration and doses of study medication, location of hospitalization and LOS, comedications, tests and procedures, and outpatient service usage. Unit costs for the medical resources were obtained from secondary sources. RESULTS: A total of 203 patients (97 treated withlinezolid and 106 treated with teicoplanin) were enrolled from these 7 countries. The unadjusted results showed that compared with teicoplanin, patients treated with linezolid had a 3.1-day shorter mean i.v. antibiotic treatment duration (P < 0.001), a 2.0- to 2.2-day shorter median and mean LOS (P = 0.03), and a 311 US dollars lower mean total cost of treatment (P = NS). After controlling for age, race, sex, site of infection, inpatient location when the antibiotic treatment started, number of historical and current comorbidities, and whether the patient had a diagnosis of systemic inflammatory response syndrome or sepsis, the multivariate adjusted results were similar to the unadjusted results. The linezolid group had a 1.6-day shorter adjusted LOS or 66% greater odds of early discharge (P = 0.049) and a 335 US dollars lower adjusted mean total cost of treatment (P = NS). CONCLUSION:Linezolid was associated with shorter LOS and duration of IV antibiotic treatment than teicoplanin for serious gram-positive infections in the population studied. Linezolid therapy has the potential to reduce the total cost of treatment.
RCT Entities:
BACKGROUND:Linezolid is a novel oxazolidinone antibiotic that is effective for the treatment of gram-positive bacterial infections. The oral formulation has the potential to reduce length of stay (LOS) when used as a substitute for parenteral glycopeptide antibiotics. In a recent multinational trial comparing linezolid (i.v. followed by oral administration) with teicoplanin (i.v. alone or switched to i.m. administration), linezolid was found to have better efficacy (P = 0.005) and similar safety for treating serious gram-positive infections. OBJECTIVE: The purpose of this study was to compare hospital resource use (primarily LOS) and cost of treatment between linezolid and teicoplanin for hospitalized patients with serious gram-positive infections in South America and Mexico using data from the multinational trial. METHODS: In a multinational, Phase IIIb, open-label, comparator-controlled trial, data were collected from hospitalized patients in centers in 6 South America can countries and Mexico with suspected or confirmed serious gram-positive infections. Patients were randomly assigned to receive i.v. linezolid 600 mg BID (for the entire treatment period [7-28 days] or switched to oral linezolid 600 mg BID) or i.v. teicoplanin (for the entire treatment period or switched to i.m. teicoplanin) dosed per approved prescription information. Data on direct medical resource utilization were collected for each patient, including duration and doses of study medication, location of hospitalization and LOS, comedications, tests and procedures, and outpatient service usage. Unit costs for the medical resources were obtained from secondary sources. RESULTS: A total of 203 patients (97 treated with linezolid and 106 treated with teicoplanin) were enrolled from these 7 countries. The unadjusted results showed that compared with teicoplanin, patients treated with linezolid had a 3.1-day shorter mean i.v. antibiotic treatment duration (P < 0.001), a 2.0- to 2.2-day shorter median and mean LOS (P = 0.03), and a 311 US dollars lower mean total cost of treatment (P = NS). After controlling for age, race, sex, site of infection, inpatient location when the antibiotic treatment started, number of historical and current comorbidities, and whether the patient had a diagnosis of systemic inflammatory response syndrome or sepsis, the multivariate adjusted results were similar to the unadjusted results. The linezolid group had a 1.6-day shorter adjusted LOS or 66% greater odds of early discharge (P = 0.049) and a 335 US dollars lower adjusted mean total cost of treatment (P = NS). CONCLUSION:Linezolid was associated with shorter LOS and duration of IV antibiotic treatment than teicoplanin for serious gram-positive infections in the population studied. Linezolid therapy has the potential to reduce the total cost of treatment.