Dalbavancin use in an academic medical centre and associated cost savings.

Dalbavancin is a lipoglycopeptide antibiotic with unique weekly dosing active against Gram-positive organisms. This retrospective study included 37 patients receiving a mean of 2.7 weeks of dalbavancin. Nine patients (24%) were re-admitted to the hospital within 30 days. A total of 617 hospital days were saved, estimated to result in US$1 495 336 in savings and a mean cost avoidance of US$40 414 per patient. Dalbavancin provides a valuable antibiotic option that may minimise healthcare expenditure.

Economic evaluation of the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) from the national payer perspective: introduction of a new treatment to the patient journey. A simulation of three European countries.

Background: The aim of this study was to develop a spending predictor model to evaluate the direct costs associated with the management of ABSSSIs from the National health-care provider's perspective of Italy, Romania, and Spain. Methodology: A decision-analytic model was developed to evaluate the diagnostic and clinical pathways of hospitalized ABSSSI patients based on scientific guidelines and real-world data. A Standard of Care (SoC) scenario was compared with a dalbavancin scenario in which the patients could be discharged early. The epidemiological and cost parameters were extrapolated from national administrative databases (i.e., hospital information system). A probabilistic sensitivity analysis (PSA) and one-way sensitivity analysis (OWA) were performed. Results: Overall, the model estimated an average annual number of patients with ABSSSIs of approximately 50,000 in Italy, Spain, and Romania. On average, the introduction of dalbavancin reduced the length of stay by 3.3 days per ABSSSI patient. From an economic perspective, dalbavancin did not incur any additional cost from the National Healthcare perspective, and the results were consistent among the countries. The PSA and OWA demonstrated the robustness of these results. Conclusion: This model represents a useful tool for policymakers by providing information regarding the economic and organizational consequences of an early discharge approach in ABSSSI management.

A cost-minimization analysis of dalbavancin compared to conventional therapy for the outpatient treatment of acute bacterial skin and skin-structure infections.

INTRODUCTION: Acute bacterial skin and skin-structure infections (ABSSSI) are common infectious diseases (ID) that often require intravenous (IV) antibiotics. Dalbavancin is a novel lipoglycopeptide antibiotic administered once that is FDA-approved for the treatment of ABSSSI. No literature is available for real-world cost-comparability relative to conventional therapy. METHODS: This retrospective chart review examined adults diagnosed with ABSSSI and treated with IV antibiotics at an outpatient ID clinic after hospital discharge from January 2015 to August 2016. Patients received either dalbavancin or conventional therapy. In-hospital baseline demographics as well as outpatient clinical variables and outcomes were assessed. The primary outcome was the total ID-related cost of care per patient. A Monte Carlo probalistic sensitivity analysis was conducted. RESULTS: One hundred and fifty-eight patients were included: 64 received dalbavancin and 94 received conventional therapy. The total ID-related cost of care per patient was greater with dalbavancin (mean $4,561) vs conventional (mean $1,668), p < 0.01. In the subset of patients treated with daptomycin, the total ID-related cost (mean $5,218) was comparable to dalbavancin (mean $4,561). CONCLUSIONS: Dalbavancin was more costly than conventional therapy for the outpatient treatment of ABSSSI. This greater overall cost was likely driven by the higher acquisition cost of dalbavancin. Dalbavancin may be comparable to the daily use of daptomycin for ABSSSI.

Pharmacokinetic drug evaluation of dalbavancin for the treatment of skin infections.

INTRODUCTION: Acute bacterial skin and skin structure infections (ABSSIs), defined as a bacterial infection of the skin with a lesion size area of at least 75 cm, are a leading cause of hospital admission and ambulatory care visits worldwide. Dalbavancin is a lipoglycopeptide antibiotic recently approved by the United States Food and Drug Administration (FDA) and by European Medicines Agency (EMA) for ABSSSIs. The authors review and provide updates of efficacy and safety by several studies on dalbavancin. Areas covered: A PubMed search was performed for relevant literature. We especially focused our attention on pharmacokinetics. Expert opinion: Dalbavancin provides an important new therapy for management of ABSSI, maintaining a spectrum of activity similar to vancomycin against gram-positive organisms. Use of dalbavancin, with its 1-week-shot treatment, consist in a reduction of the length of hospital stay or in a reduction of hospital admissions, with important cost savings.

Newer glycopeptide antibiotics for treatment of complicated skin and soft tissue infections: systematic review, network meta-analysis and cost analysis.

OBJECTIVES: Skin and soft tissue infections (SSTIs) carry significant economic burden, as well as morbidity and mortality, especially when caused by methicillin-resistant Staphylococcus aureus (MRSA). Several new MRSA-active antibiotics have been developed, including semisynthetic glycopeptides (telavancin, dalbavancin and oritavancin). Of these, dalbavancin and oritavancin offer extended dosing intervals. METHODS: We performed a systematic review, network meta-analysis and cost analysis to compare the newer glycopeptides to standard care and to each other for the treatment of complicated SSTIs (cSSTI). A search for randomized controlled trials (RCTs) was conducted in Medline, Embase and the Cochrane Central Register of Controlled Trials. We also developed a model to evaluate the costs associated with dalbavancin and oritavancin from the third-party payer perspective. RESULTS: Seven RCTs met the inclusion criteria. Network meta-analyses suggested that the clinical response to telavancin, dalbavancin and oritavancin was similar to standard care (odds ratio (OR) 1.09, 95% confidence interval (CI) 0.90-1.33; OR 0.78, 95% CI 0.52-1.18; and OR 1.06, 95% CI 0.85-1.33, respectively). Head-to-head comparisons showed no difference in clinical response between oritavancin and dalbavancin (OR 1.36; 95% CI 0.85-2.18), oritavancin and telavancin (OR 0.98; 95% CI 0.72-1.31) or dalbavancin and telavancin (OR 0.72; 95% CI 0.45-1.13). Telavancin had a higher incidence of overall adverse events compared to standard care (OR 1.33; 95% CI 1.10-1.61). Compared to telavancin, there were fewer overall adverse events with dalbavancin (OR 0.58; 95% CI 0.45-0.76) and oritavancin (OR 0.71; 95% CI 0.55-0.92). Studies were of high quality overall. Our cost analyses demonstrated that dalbavancin and oritavancin were less costly compared to standard care under baseline assumptions and many scenarios evaluated. The use of dalbavancin could save third-party payers $1442 to $4803 per cSSTI, while the use of oritavancin could save $3571 to $6932 per cSSTI. CONCLUSIONS: Dalbavancin and oritavancin demonstrate efficacy and safety comparable to standard care in well-designed RCTs and result in cost savings when standard care is treatment that covers MRSA.

New Gram Positive Agents to Treat Acute Bacterial Skin and Skin Structure Infections.

The FDA guidance published in 2013 provided requirements for conducting ABSSSI trials. In 2014, dalbavancin, oritavancin, and tedizolid were introduced into the market after phase III noninferiority clinical trials against vancomycin (for the lipoglycopeptides) and linezolid (for tedizolid), demonstrating clinical efficacy for the treatment of ABSSSI. Great interest exists for these agents because of the postulated financial impact. Due to favorable pharmacokinetics which allow for less frequent medication administration and shorter treatment durations, these agents may prove to reduce hospital admissions and length of stay.

The impact of a nationwide antibiotic restriction program on antibiotic usage and resistance against nosocomial pathogens in Turkey.

PURPOSE: Antimicrobial resistance among microorganisms is a global concern. In 2003, a nationwide antibiotic restriction program (NARP) was released in Turkey. In this study we evaluated the effect of NARP on antibiotic consumption, antimicrobial resistance, and cost. MATERIALS AND METHODS: The data obtained from all of the four university hospitals, and one referral tertiary-care educational state hospital in Ankara. Antimicrobial resistance profiles of 14,233 selected microorganisms all grown in blood cultures and antibiotic consumption from 2001 to 2005 were analyzed retrospectively. RESULTS: A negative correlation was observed between the ceftriaxone consumption and the prevalence of ceftriaxone resistant E.coli and Klebsiella spp. (rho:-0.395, p:0.332 and rho:-0.627, p:0.037, respectively). The decreased usage of carbapenems was correlated with decreased carbapenems-resistant Pseudomonas spp. and Acinetobacter spp (rho:0.155, p:0.712 and rho:0.180, p:0.668, respectively for imipenem). Methicillin resistance rates of S.aureus were decreased from 44% to 41%. After two years of NARP 5,389,155.82 USD saving occurred. CONCLUSION: NARP is effective in lowering the costs and antibiotic resistance.

Nephrotoxicity of vancomycin in patients with methicillin-resistant Staphylococcus aureus bacteraemia.

AIM: Vancomycin and teicoplanin are the two most used glycopeptides for the treatment of methicillin-resistant Staphylococcus aureus (MRSA). Vancomycin is suspected to have more nephrotoxicity but this has not been clearly established. The aim of this study was to assess its nephrotoxicity by a consensus definition of acute kidney injury (AKI): the risk (R), injury (I), failure (F), loss and end-stage renal disease (RIFLE) classification. METHODS: Patients with MRSA bacteraemia who were prescribed either vancomycin or teicoplanin between 2003 and 2008 were classified. Patients who developed AKI were classified by RIFLE criteria. Variables such as comorbidities, laboratory data and medical cost information were also obtained from the database. Outcomes determined were: (i) the rate of nephrotoxicity and mortality; and (ii) the association of nephrotoxicity with the length of hospital stay and costs. RESULTS: The study included 190 patients (vancomycin 33, teicoplanin 157). Fifteen patients on vancomycin and 27 patients on teicoplanin developed AKI (P = 0.0004). In the vancomycin group, four, eight and three patients were classified to RIFLE criteria R, I and F, respectively. In the teicoplanin group, 17, nine and one patient were classified to RIFLE criteria R, I and F, respectively. Kaplan-Meier analysis showed significant difference in time to nephrotoxicity for the vancomycin group compared to the teicoplanin group. No significant differences were found between the groups in terms of total mortality, length of hospital stay and costs. CONCLUSION: The study data suggest that vancomycin is associated with a higher likelihood of nephrotoxicity using the RIFLE classification.

Are glycopeptides still appropriate and convenient for empiric use?

The glycopeptides vancomycin and teicoplanin are widely used, and indeed recommended for, the treatment of severe or resistant Gram-positive infections. Therapeutic drug monitoring is widely used for vancomycin but less commonly for teicoplanin, and remains controversial. We report the cost savings of a formulary decision to replace teicoplanin with daptomycin for the empiric treatment of complicated skin and soft tissue infections (CSSTIs), staphylococcal bacteraemia and hospital-acquired Gram-positive sepsis. In the Intensive Therapy Unit (ITU) we optimised treatment of serious Gram-positive infections by substituting teicoplanin with vancomycin administered by continuous infusion. Costs were calculated using British National Formulary (BNF) prices and costs for therapeutic drug monitoring. Daptomycin (350 mg/d) use was associated with a cost saving per 7 days of treatment of 86 pounds and vancomycin with 51 pounds (4 g/d) to 276 pounds (2 g/d) compared to the 600 mg teicoplanin dose. Our own formulary re-positioning of glyco/lipopeptides, i.e. the preferential use of vancomycin in the ITU and substitution of teicoplanin with daptomycin, is cost-effective and provides better therapeutic alternatives. Continuous vancomycin infusion in the ITU setting guarantees optimal dosing for severely ill patients. Daptomycin use on surgical and medical wards, apart from being marginally cheaper than teicoplanin, guarantees optimal dosing without the need for drug monitoring.

Vancomycin vs teicoplanin in the treatment of Gram-positive infections: a pharmacoeconomic analysis in a Turkish University Hospital.

OBJECTIVE: The aim of this study was to estimate and compare the costs of vancomycin and teicoplanin in the treatment of Gram-positive hospital infections in Turkey using a cost minimisation analysis. SETTING: Hacettepe University Hospital, Ankara, Turkey. METHOD: The health-care provider's perspective was considered within formal pharmacoeconomic assessment methodology. The records of 76 patients who had been hospitalised and treated for Gram-positive infections at Hacettepe University Hospital between 16 July 2003 and 22 November 2003 were retrospectively evaluated to obtain individual data on resources and associated costs. MAIN OUTCOME MEASURE: From a cost minimisation perspective, hospital directors may consider teicoplanin to be a relevant option in addition to vancomycin. RESULT: The estimated mean treatment cost per patient was 1,780 TRY (1,101 EUR) for teicoplanin and 1,429 TRY (884 EUR) for vancomycin, with statistical analysis failing to reveal any significant difference between the two drugs in terms of these total costs (p = 0.33). This cost minimisation analysis shows that the average costs of vancomycin and teicoplanin per patient observed did not differ significantly. CONCLUSION: Other potential advantages of one drug over the other, as reported by other authors, such as differing safety profiles or advantages in administration, may ultimately decide which is preferred.

Pharmacoeconomics of linezolid.

BACKGROUND: New antibiotics efficacious in infections caused by resistant Gram-positive microorganisms and with acceptable costs for national health systems per unit of effectiveness are needed. OBJECTIVE: This paper aimed to summarize all available evidence regarding the pharmacoeconomics of linezolid. METHODS: A systematic review of pharmacoeconomic analyses through a non-restricted literature search was conducted. RESULTS/CONCLUSIONS: Linezolid, as compared to vancomycin and teicoplanin, results in a reduction of the necessary resources for the treatment of infections caused by Gram-positive microorganisms. These benefits are attributable to clinical outcomes and to savings associated with the ease of switching from intravenous to oral administration, the shorter duration of intravenous therapy and earlier hospital discharge. Likewise, linezolid, compared to vancomycin and teicoplanin, is a cost-effective treatment.

Economic evaluation of linezolid versus teicoplanin for the treatment of infections caused by gram-positive microorganisms in Spain.

The aim of this study was to perform a comparative cost-effectiveness analysis of linezolid vs teicoplanin (i.v., switching to oral/i.m. respectively) in Spain. A decision tree model was used with the results of a randomized, comparative, controlled clinical trial with linezolid vs teicoplanin in the treatment of infections caused by Gram-positive microorganisms, with a timeline of 31 days. The efficacy endpoint was the percentage of patients with clinical healing or improvement in their infection. Direct medical costs were included using Spanish 2005 prices. Average cost per patient, average cost-effectiveness ratio and several sensitivity analyses were carried out. In the intent-to-treat (ITT) analysis linezolid obtained a higher percentage of therapeutic success than teicoplanin (95.5% vs 87.6% respectively, p = 0.005), both with similar tolerability. The average cost per treated patient was euro 8,064.76 for linezolid vs euro 8,727.36 for teicoplanin, with an incremental cost of euro 622.59 (-7,6%). Linezolid yielded a lower average cost-effectiveness ratio, euro 8,444.78 (8,195.90 - 8,709.25) than teicoplanin, euro 9,962.74 (9,465.68 - 10,502.23), with a slight reduction in average cost per successfully treated patient of 15.2% ( euro 1,517.96). The results were robust to the sensitivity analysis. In conclusion, linezolid is a more cost-effective option than teicoplanin in the treatment of infections caused by Gram-positive microorganisms, since it offers superior clinical benefits with a lower use of associated resources.

Health economics assessment study of teicoplanin versus vancomycin in Gram-positive infections.

The objective of this study, conducted at Hospital Clínico San Carlos, Madrid, Spain, was to compare the cost of treatment of Gram-positive infections with teicoplanin and vancomycin under normal conditions. Using a prospective observational study design for drug utilization and economic assessment, we evaluated the comparability of the sample, adverse events, features of treatment with teicoplanin/vancomycin and factors influencing the consumption of resources until the end of glycopeptide treatment or discharge (whichever occurred later) using Health System perspective. Costs were assigned using the hospital's evaluation at the time of the study. Analyses made: multivariate, sensitivity (by modifying staff or acquisition costs) and simulation of reduction of stay by early discharge in the teicoplanin group. Study participants included 201 patients who had been using teicoplanin (n=100) or vancomycin (n=101) for at least four days. Data collected daily outside morning work timetable. Costs of acquisition, administration and monitoring by course of treatment (mean+/-SD, in euros) were lower in the vancomycin group (teicoplanin euro647.62+/-euro572.75 vs. vancomycin euro378.11+/-euro225.90); when total costs (including hospital stay) were considered, no differences were found (teicoplanin euro4,432.04+/-euro3,383.46 vs. vancomycin euro4,364.44+/-euro2,734.24). Conditions of use and results were similar for both antibiotics. The economic results of acquisition, administration and monitoring were advantageous for vancomycin; when global costs of care were taken into account, these differences were not evident. Tolerability was significantly advantageous in the teicoplanin group (with regard to phlebitis and elevation of creatininemia), without differences in clinical or economic outcomes. The formulation of teicoplanin did not take advantage of its potential benefits of administration.

Health economics assessment study of teicoplanin versus vancomycin in Gram-positive infections

El objetivo de este estudio, realizado en el Hospital Clínico San Carlos de Madrid, en España, fue comparar el coste del tratamiento de las infecciones por grampositivos con teicoplanina y vancomicina en la práctica clínica habitual. Mediante un diseño prospectivo observacional orientado al análisis de la utilización del fármaco y la valoración económica, se evaluó el grado de comparabilidad de la muestra, los efectos adversos, las características del tratamiento con teicoplanina/vancomicina y los factores que influyeron sobre la utilización de los recursos sanitarios hasta el final del tratamiento con el glucopéptido o el alta hospitalaria (tomando como referencia siempre lo que ocurriese más tarde) desde la perspectiva de los Servicios de Salud. Los costes se calcularon según la evaluación hospitalaria durante el periodo del estudio. Se realizó un análisis multivariado, de sensibilidad (modificando los costes de adquisición o relativos al personal sanitario) y de simulación de la reducción de la estancia hospitalaria por la anticipación del alta en el grupo tratado con teicoplanina. En el estudio participaron 201 pacientes tratados con teicoplanina (n=100) o vancomicina (n=101) durante al menos cuatro días. Toda la información relativa a los pacientes del estudio se recogió diariamente. Los costes de adquisición y administración del fármaco y de control de los pacientes durante el tratamiento (media ± DE, en euros) fueron menores en el grupo tratado con vancomicina (647,62 ± 572,75 para la teicoplanina frente a 378,11 ± 225,90 para la vancomicina); cuando se consideraron los costes globales, incluyendo la estancia hospitalaria, no se hallaron diferencias entre ambos grupos (4432,04 ± 3383,46 para la teicoplanina y 4364,44 ± 2734,24 para la vancomicina). Las condiciones de uso y los resultados obtenidos fueron similares con ambos antibióticos. El coste económico de la adquisición y administración del fármaco y del control de los pacientes fue menor en el grupo tratado con vancomicina, pero cuando se consideraron los costes globales incluyendo la estancia hospitalaria, fueron similares en ambos grupos. La tolerabilidad fue significativamente mejor en el grupo tratado con teicoplanina (con relación a la aparición de flebitis y elevaciones de la creatininemia), sin que existiesen diferencias en la eficacia clínica ni el coste económico. La formulación de teicoplanina no mostró ningún posible beneficio en cuanto a la administración

The objective of this study, conducted at Hospital Clínico San Carlos, Madrid, Spain, was to compare the cost of treatment of Gram-positive infections with teicoplanin and vancomycin under normal conditions. Using a prospective observational study design for drug utilization and economic assessment, we evaluated the comparability of the sample, adverse events, features of treatment with teicoplanin/vancomycin and factors influencing the consumption of resources until the end of glycopeptide treatment or discharge (whichever occurred later) using Health System perspective. Costs were assigned using the hospital’s evaluation at the time of the study. Analyses made: multivariate, sensitivity (by modifying staff or acquisition costs) and simulation of reduction of stay by early discharge in the teicoplanin group. Study participants included 201 patients who had been using teicoplanin (n = 100) or vancomycin (n = 101) for at least four days. Data collected daily outside morning work timetable. Costs of acquisition, administration and monitoring by course of treatment (mean ± SD, in euros) were lower in the vancomycin group (teicoplanin ;647.62 ± ;572.75 vs. vancomycin ;378.11 ± ;225.90); when total costs (including hospital stay) were considered, no differences were found (teicoplanin ;4,432.04 ± ;3,383.46 vs. vancomycin ;4,364.44 ± ;2,734.24). Conditions of use and results were similar for both antibiotics. The economic results of acquisition, administration and monitoring were advantageous for vancomycin; when global costs of care were taken into account, these differences were not evident. Tolerability was significantly advantageous in the teicoplanin group (with regard to phlebitis and elevation of creatininemia), without differences in clinical or economic outcomes. The formulation of teicoplanin did not take advantage of its potential benefits of administration

Pharmacoeconomic evaluation of linezolid versus teicoplanin in bacteremia by Gram-positive microorganisms.

OBJECTIVE: The objective of this study was to compare the efficiency of linezolid versus teicoplanin in the treatment of bacteremia produced by Gram-positive microorganisms through a pharmacoeconomic analysis based on clinical results obtained from a previous clinical trial. METHODS: We applied an analysis of cost-effectiveness elaborated through a pharmacoeconomic model. We defined each unit of effectiveness as 'each successfully cured of infections with bacteremia.' We used the program Pharma-Decision (version Hospital 1.1) that allows to build interactive pharmacoeconomic models. Effectiveness data of both antibiotics were obtained from a published clinical trial, while resources consumed were obtained from the same source and from a consensus provided by a local expert panel. Only direct costs were included in the analysis without taking into consideration indirect costs. The perspective chosen was hospital assistance and the time horizon was set to 28 days. All costs are expressed in Euros. RESULTS: Linezolid demonstrated a better clinical outcome with less associated costs compared to teicoplanin (88.5 versus 56.7% of cured patients and 5,557.04 versus 6,327.43 per treated patient, respectively), thus resulting in a lower cost-effectiveness ratio for linezolid versus teicoplanin (6,279.1 versus 11,159.5 per cured patient with a 95% CI of 5,960.2-6,510.4 and 10,865.2-12,647.3, respectively) which results in a the dominant position for linezolid. The sensitivity analysis showed that linezolid was always the most efficient option even when modifying the value of variables with higher uncertainty. CONCLUSIONS: Linezolid is a more efficient option than teicoplanin because it presents higher rate of effectiveness with lower consumption of resources, thus being a dominant alternative in the treatment of Gram-positive infection with bacteremia.

Addition of teicoplanin or vancomycin for the treatment of documented bacteremia due to gram-positive cocci in neutropenic patients with hematological malignancies: microbiological, clinical and economic evaluation.

A prospective, randomized, double-blind trial was conducted on 124 febrile patients with hematological malignancies to compare teicoplanin with vancomycin as an addition to the initial empiric amikacin-ceftazidime regimen after documented bacteremia due to gram-positive cocci. At enrollment, patients in both groups were comparable with respect to age, sex, underlying hematologic disorders and duration of neutropenia. Rates of therapeutic success were 55/63 (87.3%) in the teicoplanin group and 56/61 (91.8%) in the vancomycin group (p = 0.560). The mean duration of treatment was similar, being 12.2 and 11.4 days, respectively (p = 0.216). Patients treated with teicoplanin remained febrile for slightly longer than those treated with vancomycin (4.9 vs. 4.0 days) (p = 0.013). Thirteen patients experienced an adverse drug reaction, but without any significant difference in the two arms. Isolated staphylococci showed a progressive and significant decrease in susceptibility to both glycopeptides during the 8 study years. The economic analysis performed showed that the addition of vancomycin is cost-saving.

An economic evaluation of a European cohort from a multinational trial of linezolid versus teicoplanin in serious Gram-positive bacterial infections: the importance of treatment setting in evaluating treatment effects.

In a recent multinational trial, hospital resource use and total cost of treatment were compared between linezolid and teicoplanin for severe Gram-positive bacterial infections among 227 European hospitalised patients. The results show that the linezolid group had a 3.2-day (6.3 for linezolid versus 9.5 for teicoplanin groups) shorter mean intravenous antibiotic treatment duration. Certain baseline variables, particularly the inpatient location at enrolment and the presence of outpatient/home parenteral antibiotic therapy (OHPAT), had substantial effects on length of stay (LOS) and cost of treatment. After adjusting for the between-treatment difference in these two variables and other baseline variables, the results showed non-significant shorter LOS and lower mean total cost of treatment for the linezolid group among patients with no access to OHPAT.

Linezolid compared with teicoplanin for the treatment of suspected or proven Gram-positive infections.

The efficacy, safety and tolerability of linezolid was compared with teicoplanin in a randomized, controlled, open-label, multicentre study of 430 patients with suspected or proven Gram-positive infection. Patients received intravenous (iv) +/- oral linezolid 600 mg every 12 h (n = 215) or iv or intramuscular teicoplanin (n = 215) for up to 28 days. Clinical outcomes in the intent-to-treat (ITT) and clinically-evaluable populations and microbiological success rates in microbiologically evaluable patients were assessed at follow-up (test of cure). Investigator assessed clinical cure rates at end of treatment (EOT) in ITT patients treated with linezolid (95.5%) were superior to those of teicoplanin (87.6%) for all infections combined, indicating a 7.9% statistically significant treatment advantage for linezolid (P = 0.005, 95% CI: 2.5, 13.2). Clinical cure rates by baseline diagnosis were consistently higher at EOT for the linezolid versus teicoplanin groups with skin and soft tissue infection (96.6% versus 92.8%), pneumonia (96.2% versus 92.9%) and bacteraemia (88.5% versus 56.7%). The 31.8% treatment advantage in bacteraemic patients (but not for those seen in the other infection categories) for linezolid-treated patients was statistically significant (P = 0.009, 95% CI: 10.2, 53.4). Bacterial eradication rates for linezolid exceeded those of teicoplanin for all infection sites combined but this did not reach statistical significance (81.9% versus 69.8%, respectively; P = 0.056). Adverse event rates were similar between the treatment groups, were mild to moderate in severity, and resolved quickly following treatment. The linezolid group experienced a higher incidence of drug related adverse events (30% versus 17%; P = 0.002), and notably of gastrointestinal effects (13.0% versus 1.9%, P = 0.001). However, antibiotic discontinuation rates as a result of drug related adverse events were similar (4.7% in the linezolid group versus 3.7%). Linezolid was clinically superior to teicoplanin in the treatment of Gram-positive infections.