scholarly journals Ceftazidime–Avibactam versus Meropenem for the Treatment of Complicated Intra-Abdominal Infections

Antibiotics ◽  
2019 ◽  
Vol 8 (4) ◽  
pp. 255 ◽  
Author(s):  
Che-Kim Tan ◽  
Chih-Cheng Lai ◽  
Chien-Ming Chao
Keyword(s):  
Adverse Events ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Study Drug ◽  
Comparable Efficacy ◽  
Integrated Analysis ◽  
Cure Rate ◽  
Serious Adverse Events ◽  
Mitt Population ◽  
Abdominal Infections

This study reports an integrated analysis of three randomized controlled trials to compare the clinical efficacies and safety of the ceftazidime–avibactam (CAZ–AVI) combination and meropenem in the treatment of adult patients with complicated intra-abdominal infections (cIAIs). Overall, a total of 1677 patients (CAZ–AVI: 835 patients; meropenem: 842 patients) were included in this analysis. CAZ–AVI had a clinical cure rate at test of cure in the clinically evaluable (CE) population similar to that of meropenem (OR, 0.88; 95% CI, 0.58–1.32; I2 = 0%). Similar trends were also observed in the modified intent-to-treat (MITT) population (OR, 0.80; 95% CI, 0.59–1.09; I2 = 0%) and microbiological evaluable (ME) population (OR, 0.73; 95% CI, 0.32–1.68; I2 = 0%). In terms of clinical cure rate at the end of treatment, the efficacy of CAZ–AVI was comparable to that of meropenem in the CE population (OR, 0.77; 95% CI, 0.47–1.25; I2 = 0%), MITT population (OR, 0.70; 95% CI, 0.47–1.06; I2 = 5%), and ME population (OR, 1.26; 95% CI, 0.39–4.08; I2 = 0%). CAZ–AVI had a similar risk of (i) treatment emergent adverse events (TEAEs) (OR, 1.03; 95% CI, 0.79–1.36; I2 = 38%), (ii) any serious adverse events (OR, 0.97; 95% CI, 0.67–1.40; I2 = 0%), (iii) discontinuation of study drug due to TEAE (OR, 2.14; 95% CI, 1.00–4.57), and iv) all-cause mortality (OR, 1.66; 95% CI, 0.78–3.53; I2 = 0%) when compared with meropenem. In conclusion, CAZ–AVI had comparable efficacy and safety profile to those of meropenem in the treatment of cIAI.

scholarly journals Meropenem-Vaborbactam in the Treatment of Acute Bacterial Infections

2019 ◽  
Vol 8 (10) ◽  
pp. 1650 ◽  
Author(s):  
Chih-Cheng Lai ◽  
Chi-Chung Chen ◽  
Hung-Jen Tang
Keyword(s):  
Adverse Events ◽  
Clinical Cure ◽  
Bacterial Infections ◽  
Complicated Urinary Tract Infection ◽  
Phase Iii ◽  
Integrated Analysis ◽  
Control Group ◽  
Serious Adverse Events ◽  
Risk Of Death ◽  
Acute Bacterial Infections

This study reports the integrated analysis of two phase III studies of meropenem-vaborbactam in the treatment of acute bacterial infections. Targeting Antibiotic Non-Susceptible Gram-Negative Organisms (TANGO) I compared the clinical efficacy and tolerability of meropenem-vaborbactam and piperacillin-tazobactam in the treatment of complicated urinary tract infection (cUTI)/acute pyelonephritis (APN). TANGO II compared the effect and safety of meropenem-vaborbactam and best-available therapy in the treatment confirmed/suspect carbapenem-resistant Enterobacteriaceae infections. The clinical cure rates at end of treatment (EOT) and test of cure (TOC) among the meropenem-vaborbactam group were non-inferior to those of the control group (at EOT, 92.5% versus 89.3%, risk ratio (RR) 1.27, 95% CI 0.64–2.50; at TOC, 86.2% versus 81.7%, RR 1.37, 95% CI 0.62–3.01). Meropenem-vaborbactam was non-inferior to comparators for microbiological eradication at EOT and TOC (at EOT, 93.3% versus 88.3%, RR 1.21, 95% CI 0.74–1.97; at TOC, 66.5% versus 59.9%, RR 1.12, 95% CI 0.97–1.30). In the subgroup of patients with cUTI/APN, meropenem-vaborbactam had similar overall success rate to the control group at EOT (RR 1.05, 95% CI 1.01–1.09) and at TOC (RR 1.05, 95% CI 0.93–1.19). Meropenem-vaborbactam had a similar risk of treatment-emergent adverse events, events leading to discontinuation of the study drug, any serious adverse events, life-threatening adverse events, drug-related adverse events, and risk of death to comparators. In conclusion, meropenem-vaborbactam was noninferior to comparators for clinical cure and microbiological eradication in the treatment of acute bacterial infection, particularly cUTI/APN, and meropenem-vaborbactam was as tolerable as comparators.

scholarly journals Retrospective Review on the Safety and Efficacy of Nitrofurantoin for the Treatment of Cystitis in the Veteran Population With or Without Renal Insufficiency

2021 ◽  
Vol 8 (9) ◽  
Author(s):  
Elwyn Welch ◽  
Shaila Sheth ◽  
Chester N Ashong ◽  
Caroline Pham
Keyword(s):  
Adverse Events ◽  
Renal Dysfunction ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Retrospective Chart Review ◽  
Secondary Outcome ◽  
Cure Rate ◽  
Acute Cystitis ◽  
Significant Difference ◽  
Males And Females

Abstract Background The emergence of antimicrobial resistance in uropathogens has generated interest in the use of nitrofurantoin in controversial populations, such as in males and those with renal dysfunction. The purpose of this study was to compare the efficacy and safety of nitrofurantoin for the treatment of cystitis in males and females with variable degrees of renal dysfunction. Methods A retrospective chart review was conducted in adult patients who received nitrofurantoin for acute cystitis in the outpatient setting. The primary outcome was clinical cure compared between males and females and across various renal function groups (creatinine clearances [CrCl] >60 mL/min, 30–60 mL/min, and <30 mL/min) following nitrofurantoin treatment. The secondary outcome was adverse events. Results A total of 446 patients were included, with 278 females and 168 males. The overall clinical cure rate was 86.5% (95% CI, 83.0%–89.4%; n = 386). The clinical cure rate did not vary between genders (odds ratio [OR], 0.6; 95% CI 0.35–1.04; P = .085) or between patients with a CrCl >60 mL/min compared with those with CrCl 30–60 mL/min (OR, 1.01; 95% CI, 0.40–2.44; P = 1). The 1 patient with a CrCl <30 mL/min was not included in the analysis. A history of benign prostatic hyperplasia (OR, 0.5; 95% CI, 0.26–0.99; P = .045) or cirrhosis (OR, 0.21; 95% CI, 0.06–0.82; P = .025) was associated with decreased odds of clinical cure. Adverse events occurred in 2% (n = 9) of patients. Conclusions There was no statistically significant difference in clinical cure with nitrofurantoin between genders or various renal functions.

scholarly journals Efficacy and Safety of Ceftaroline for the Treatment of Community-Acquired Pneumonia: A Systemic Review and Meta-Analysis of Randomized Controlled Trials

2019 ◽  
Vol 8 (6) ◽  
pp. 824 ◽  
Author(s):  
Shao-Huan Lan ◽  
Shen-Peng Chang ◽  
Chih-Cheng Lai ◽  
Li-Chin Lu ◽  
Chien-Ming Chao
Keyword(s):  
Randomized Controlled Trials ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Meta Analysis ◽  
Community Acquired Pneumonia ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Cure Rate ◽  
Mitt Population ◽  
Randomized Controlled

This study aimed to compare the clinical efficacy and safety of ceftaroline with those of ceftriaxone for treating community-acquired pneumonia (CAP). The PubMed, Cochrane Library, Embase, and clinicalTrials.gov databases were searched until April 2019. This meta-analysis only included randomized controlled trials (RCTs) that evaluated ceftaroline and ceftriaxone for the treatment of CAP. The primary outcome was the clinical cure rate, and the secondary outcome was the risk of adverse events (AEs). Five RCTs were included. Overall, at the test of cure (TOC), the clinical cure rate of ceftaroline was superior to the rates of ceftriaxone for the treatment of CAP (modified intent-to-treat population (MITT) population, odds ratio (OR) 1.61, 95% confidence interval (CI) 1.31–1.99, I2 = 0%; clinically evaluable (CE) population, OR 1.38, 95% CI 1.07–1.78, I2 = 14%). Similarly, the clinical cure rate of ceftaroline was superior to that of ceftriaxone at the end of therapy (EOT) (MITT population, OR 1.57, 95% CI 1.16–2.11, I2 = 0%; CE population, OR 1.64, 95% CI 1.15–2.33, I2 = 0%). For adult patients, the clinical cure rate of ceftaroline remained superior to that of ceftriaxone at TOC (MITT population, OR 1.66, 95% CI 1.34–2.06, I2 = 0%; CE population, OR 1.39, 95% CI 1.08–1.80, I2 = 30%) and at EOT (MITT population, OR 1.64, 95% CI 1.20–2.24, I2 = 0%; CE population, OR 1.65, 95% CI 1.15–2.36, I2 = 0%). Ceftaroline and ceftriaxone did not differ significantly in the risk of serious AEs, treatment-emergent AEs, and discontinuation of the study drug owing to an AE. In conclusion, the clinical efficacy of ceftaroline is similar to that of ceftriaxone for the treatment of CAP. Furthermore, this antibiotic is as tolerable as ceftriaxone.

scholarly journals 1692. Retrospective Review on the Safety and Efficacy of Nitrofurantoin for the Treatment of Cystitis in the Veteran Population With or Without Renal Insufficiency

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S829-S830
Author(s):  
Elwyn W Welch ◽  
Shaila Sheth ◽  
Chester Ashong ◽  
Caroline Pham
Keyword(s):  
Renal Function ◽  
Renal Dysfunction ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Retrospective Chart Review ◽  
Outpatient Setting ◽  
Secondary Outcome ◽  
Cure Rate ◽  
Acute Cystitis ◽  
Significant Difference

Abstract Background Nitrofurantoin has been used to treat cystitis in women; however, data supporting its use in men is lacking. In addition, recent retrospective studies have challenged the manufacturer’s recommendation to avoid nitrofurantoin with creatinine clearances (CrCl) less than 60 mL/min. The purpose of this study is to compare the efficacy and safety of nitrofurantoin for the treatment of acute cystitis in male and female veterans with variable degrees of renal dysfunction. Methods A retrospective chart review was conducted in adult patients who received nitrofurantoin for acute cystitis in the outpatient setting between May 1, 2018 and May 1, 2019. The primary outcomes were rates of clinical cure as compared between males and females, and across various renal function groups (CrCl greater than 60 mL/min, 30 to 60 mL/min, and less than 30 mL/min) following treatment with nitrofurantoin. The secondary outcome was adverse event rates. Results A total of 446 patients were included with 278 females and 168 males. Overall clinical cure rate was 86.5% (n=386). Clinical cure rate did not vary between genders (p=0.0851) or CrCl ranges (p=1.0) as shown in the tables. Benign prostatic hyperplasia (BPH) was associated with decreased odds of clinical cure (OR 0.50 [95% CI 0.26-0.97], p=0.0404) in addition to cirrhosis (OR 0.22 [95% CI 0.06-0.91], p=0.0357). Adverse events occurred in 2% of patients and did not vary based on gender or renal function. RATES OF CLINICAL CURE Conclusion There was no statistically significant difference in clinical cure with nitrofurantoin between genders and various renal impairments. However, history of BPH and cirrhosis were associated with decreased efficacy. Subgroup analysis also revealed lower efficacy in males with CrCl greater than 60 mL/min versus females with similar renal function. This study adds to the growing body of literature suggesting that renal dysfunction with CrCl of 30 to 60 mL/min may not carry the risk of treatment failure and adverse effects previously associated with nitrofurantoin, but large randomized trials are needed to confirm these results. Disclosures All Authors: No reported disclosures

scholarly journals Phase 2 Study of Ceftaroline versus Standard Therapy in Treatment of Complicated Skin and Skin Structure Infections

2007 ◽  
Vol 51 (10) ◽  
pp. 3612-3616 ◽  
Author(s):  
George H. Talbot ◽  
Dirk Thye ◽  
Anita Das ◽  
Yigong Ge
Keyword(s):  
Success Rate ◽  
Standard Therapy ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Tolerability Profile ◽  
Clinical Relapse ◽  
Cure Rate ◽  
Ceftaroline Fosamil ◽  
Skin Structure ◽  
Complicated Skin

ABSTRACT Ceftaroline, the bioactive metabolite of ceftaroline fosamil (previously PPI-0903, TAK-599), is a broad-spectrum cephalosporin with potent in vitro activity against multidrug-resistant gram-positive aerobic pathogens, including methicillin-resistant Staphylococcus aureus. A randomized, observer-blinded study to evaluate the safety and efficacy of ceftaroline versus standard therapy in treating complicated skin and skin structure infections (cSSSI) was performed. Adults with cSSSI, including at least one systemic marker of inflammation, were randomized (2:1) to receive intravenous (i.v.) ceftaroline (600 mg every 12 h) or i.v. vancomycin (1 g every 12 h) with or without adjunctive i.v. aztreonam (1 g every 8 h) for 7 to 14 days. The primary outcome measure was the clinical cure rate at a test-of-cure (TOC) visit 8 to 14 days after treatment. Secondary outcomes included the microbiological success rate (eradication or presumed eradication) at TOC and the clinical relapse rate 21 to 28 days following treatment. Of 100 subjects enrolled, 88 were clinically evaluable; the clinical cure rate was 96.7% (59/61) for ceftaroline versus 88.9% (24/27) for standard therapy. Among the microbiologically evaluable subjects (i.e., clinically evaluable and having had at least one susceptible pathogen isolated at baseline), the microbiological success rate was 95.2% (40/42) for ceftaroline versus 85.7% (18/21) for standard therapy. Relapse occurred in one subject in each group (ceftaroline, 1.8%; standard therapy, 4.3%). Ceftaroline exhibited a very favorable safety and tolerability profile, consistent with that of marketed cephalosporins. Most adverse events from ceftaroline were mild and not related to treatment. Ceftaroline holds promise as a new therapy for treatment of cSSSI and other serious polymicrobial infections.

scholarly journals Impact of Colistin Dosing on the Incidence of Nephrotoxicity in a Tertiary Care Hospital in Saudi Arabia

Antibiotics ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. 485 ◽  
Author(s):  
Reem Almutairy ◽  
Waad Aljrarri ◽  
Afnan Noor ◽  
Pansy Elsamadisi ◽  
Nour Shamas ◽  
...  
Keyword(s):  
Serum Albumin ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Serum Albumin Level ◽  
Tertiary Care ◽  
Multivariable Analysis ◽  
Severity Of Illness ◽  
Albumin Level ◽  
Care Hospital ◽  
Cure Rate

Colistin therapy is associated with the development of nephrotoxicity. We examined the incidence and risk factors of nephrotoxicity associated with colistin dosing. We included adult hospitalized patients who received intravenous (IV) colistin for >72 h between January 2014 and December 2015. The primary endpoint was the incidence of colistin-associated acute kidney injury (AKI). The secondary analyses were predictors of nephrotoxicity, proportions of patients inappropriately dosed with colistin according to the Food and Drug Administration (FDA), European Medicines Agency (EMA), and Garonzik formula and clinical cure rate. We enrolled 198 patients with a mean age of 55.67 ± 19.35 years, 62% were men, and 60% were infected with multidrug-resistant organisms. AKI occurred in 44.4% (95% CI: 37.4–51.7). Multivariable analysis demonstrated that daily colistin dose per body weight (kg) was associated with AKI (OR: 1.57, 95% CI: 1.08–2.30; p = 0.02). Other significant predictors included serum albumin level, body mass index (BMI), and severity of illness. None of the patients received loading doses, however FDA-recommended dosing was achieved in 70.2% and the clinical cure rate was 13%. The incidence of colistin-associated AKI is high. Daily colistin dose, BMI, serum albumin level, and severity of illness are independent predictors of nephrotoxicity.

scholarly journals The Efficacy and Safety of Eravacycline in the Treatment of Complicated Intra-Abdominal Infections: A Systemic Review and Meta-Analysis of Randomized Controlled Trials

2019 ◽  
Vol 8 (6) ◽  
pp. 866 ◽  
Author(s):  
Shao-Huan Lan ◽  
Shen-Peng Chang ◽  
Chih-Cheng Lai ◽  
Li-Chin Lu ◽  
Chien-Ming Chao
Keyword(s):  
Adverse Event ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Clinical Failure ◽  
Efficacy And Safety ◽  
Cure Rate ◽  
Randomized Controlled ◽  
Evaluable Population ◽  
Intent To Treat ◽  
Treat Population

This study aims to assess the clinical efficacy and safety of eravacycline for treating complicated intra-abdominal infection (cIAI) in adult patients. The PubMed, Web of Science, EBSCO, Cochrane databases, Ovid Medline, Embase, and ClinicalTrials.gov were searched up to May 2019. Only randomized controlled trials (RCTs) that evaluated eravacycline and other comparators for the treatment of cIAI were included. The primary outcome was the clinical cure rate at the test-of-cure visit based on modified intent-to-treat population, microbiological intent-to-treat population, clinically evaluable population, and microbiological evaluable population, and the secondary outcomes were clinical failure rate and the risk of adverse event. Three RCTs were included. Overall, eravacycline had a clinical cure rate (88.7%, 559/630) at test-of-cure in modified intent-to-treat population similar to comparators (90.1%, 492/546) in the treatment of cIAIs (risk ratio (RR), 0.99; 95% confidence interval (CI), 0.95–1.03; I2 = 0%, Figure 3). In the microbiological intent-to-treat, clinically evaluable, and microbiological evaluable populations, no difference was found between eravacycline and comparators in terms of clinical cure rate at test-of-cure (microbiological intent-to-treat population, RR, 0.99; 95% CI, 0.95–1.04; I2 = 0%, clinically evaluable population, RR, 1.00; 95% CI, 0.97–1.03; I2 = 0%, microbiological evaluable population, RR, 0.98; 95% CI, 0.95–1.02; I2 = 0%). In addition, eravacycline had clinical failure rate similar to comparators at test-of-cure in modified intent-to-treat population (RR, 1.01; 95% CI, 0.61–0.69; I2 = 0%), microbiological intent-to-treat population (RR, 1.34; 95% CI, 0.77–2.31; I2 = 16%), clinically evaluable population (RR, 1.03; 95% CI, 0.61–1.76; I2 = 0%), and microbiological evaluable population (RR, 1.32; 95% CI, 0.75–2.32; I2 = 10%). Although eravacycline was associated with higher risk of treatment-emergent adverse event than comparators (RR, 1.34; 95% CI, 1.13–1.58; I2 = 0%), no significant differences were found between eravacycline and comparators for the risk of serious adverse event (RR, 1.04; 95% CI, 0.65–1.65; I2 = 0%), discontinuation of study drug because of adverse event (RR, 0.68; 95% CI, 0.23–1.99; I2 = 13%), and all-cause mortality (RR, 1.09; 95% CI, 0.41–2.9; I2 = 28%). In conclusion, the clinical efficacy of eravacycline is as high as that of the comparator drugs in the treatment of cIAIs and this antibiotic is as well tolerated as the comparators.

Effectiveness and Safety of Rizatriptan Benzoate 10 mg in the Treatment of Migraine Headaches

2010 ◽  
Vol 2 ◽  
pp. CMT.S4670
Author(s):  
Michel Aubé ◽  
Fridon Chouha ◽  
Julie Vaillancourt ◽  
John Sampalis
Keyword(s):  
Adverse Events ◽  
Real Life ◽  
Study Drug ◽  
Pain Severity ◽  
Open Label ◽  
Serious Adverse Events ◽  
Over The Counter ◽  
Rizatriptan Benzoate ◽  
Migraine Headaches ◽  
Real Life Setting

Background Patients that do not achieve therapeutic response with over the counter non-triptan medications may benefit from triptan-based treatments. Objective Phase I V, open-label, multi-center, prospective cohort study assessing the effectiveness of rizatriptan in the management of migraines for patients that have not responded to non-triptan treatment. Methods Patients were treated with one rizatriptan (MAXALT RPD®) 10 mg wafer at the onset of each migraine attack and were assessed after a minimum of one and a maximum of two consecutive headache episodes. Outcome measures included self-reported assessments (severity and duration of migraine headache) and the Migraine ACT questionnaire. Results A total of 369 patients were enrolled, of which 291 and 215 reported one and two attacks, respectively. For the first and second attacks, 47.2% and 53.9% of patients reported complete resolution of pain while 73.6% and 77.0% reported pain severity reduction within two hours of onset. Mean (SD) pain severity score (four-point Likert scale) during the 488 migraine episodes was reduced significantly ( P < 0.001) from 2.56 (0.49) at onset to 1.91 (0.85) at 30, 1.31 (1.00) at 60 and 0.84 (1.00) at 120 minutes. Similar improvements were observed for changes in Migraine ACT questionnaire scores. No treatment-related serious adverse events were reported. The most frequently reported non-serious adverse events that were attributed to the study drug were dizziness (2.2%), chest discomfort (1.1%), nausea (1.1%), and somnolence (0.8%). Conclusion In a real-life setting, rizatriptan benzoate 10 mg is effective and safe in the treatment of acute migraine headaches in patients who do not respond to non-triptan treatment.

scholarly journals Cethromycin versus Clarithromycin for Community-Acquired Pneumonia: Comparative Efficacy and Safety Outcomes from Two Double-Blinded, Randomized, Parallel-Group, Multicenter, Multinational Noninferiority Studies

2012 ◽  
Vol 56 (4) ◽  
pp. 2037-2047 ◽  
Author(s):  
Marci L. English ◽  
Christine E. Fredericks ◽  
Nancy A. Milanesio ◽  
Nestor Rohowsky ◽  
Ze-Qi Xu ◽  
...  
Keyword(s):  
Clinical Cure ◽  
Clinical Cure Rate ◽  
The United States ◽  
Community Acquired Pneumonia ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Cure Rate ◽  
Content Type ◽  
Dosing Regimens ◽  
Double Blinded

ABSTRACTCommunity-acquired pneumonia (CAP) continues to be a major health challenge in the United States and globally. Factors such as overprescribing of antibiotics and noncompliance with dosing regimens have added to the growing antibacterial resistance problem. In addition, several agents available for the treatment of CAP have been associated with serious side effects. Cethromycin is a new ketolide antibiotic that may provide prescribing physicians with an additional agent to supplement a continually limited armamentarium. Two global phase III noninferiority studies (CL05-001 and CL06-001) to evaluate cethromycin safety and efficacy were designed and conducted in patients with mild to moderate CAP. Study CL05-001 demonstrated an 83.1% clinical cure rate in the cethromycin group compared with 81.1% in the clarithromycin group (95% confidence interval [CI], −4.8%, +8.9%) in the intent to treat (ITT) population and a 94.0% cethromycin clinical cure rate compared with a 93.8% clarithromycin cure rate (95% CI, −4.5%, +5.1%) in the per protocol clinical (PPc) population. Study CL06-001 achieved an 82.9% cethromycin clinical cure rate in the ITT population compared with an 88.5% clarithromycin cure rate (95% CI, −11.9%, +0.6%), whereas the clinical cure rate in the PPc population was 91.5% in cethromycin group compared with 95.9% in clarithromycin group (95% CI, −9.1%, +0.3%). Both studies met the primary endpoints for clinical cure rate based on predefined, sliding-scale noninferiority design. Therefore, in comparison with clarithromycin, these two noninferiority studies demonstrated the efficacy and safety of cethromycin, with encouraging findings of efficacy in subjects withStreptococcus pneumoniaebacteremia. No clinically significant adverse events were observed during the studies. Cethromycin may be a potential oral therapy for the outpatient treatment of CAP.

scholarly journals Prospective Study of the Wilson Severity-of-Illness Scoring System for Complicated Skin and Skin Structure Infections

2012 ◽  
Vol 57 (1) ◽  
pp. 647-650 ◽  
Author(s):  
George H. Talbot ◽  
Tanya O'Neal ◽  
Anita F. Das ◽  
Dirk Thye
Keyword(s):  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Severity Of Illness ◽  
Cure Rate ◽  
Two Phase ◽  
Ceftaroline Fosamil ◽  
Risk Class ◽  
Skin Structure ◽  
Complicated Skin ◽  
Cure Rates

ABSTRACTWilson et al. (Am. J. Surg.185:369–375, 2003) developed a disease severity classification system for use in complicated skin and skin structure infections (cSSSI). Two phase 3 trials of ceftaroline fosamil in cSSSI provided the opportunity to evaluate the association between Wilson Severity Risk Class and clinical cure rates. Our analyses did not confirm that an association exists between Wilson Severity Risk Class and clinical cure rate and, thus, did not validate its predictive utility.

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