A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities

Journal of Antimicrobial Chemotherapy

Volumn 71, Issue 12, 2016, Pages 3575-3584

  Dryden, Matthew ^a   Zhang, Yingyuan ^b   Wilson, David ^c   Iaconis, Joseph P ^c   Gonzalez, Jesus ^c,d  

^a ROYAL HAMPSHIRE COUNTY HOSPITAL   (United Kingdom)

^b FUDAN UNIVERSITY   (China)

^c ASTRAZENECA   (United Kingdom)

^d AstraZeneca ^*  (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; AZTREONAM; C REACTIVE PROTEIN; CEFTAROLINE FOSAMIL; LIVER ENZYME; VANCOMYCIN; ANTIINFECTIVE AGENT; CEPHALOSPORIN DERIVATIVE; PPI-0903;

ABDOMINAL DISTENSION; ADULT; AGED; ALANINE AMINOTRANSFERASE LEVEL; ANEMIA; ANTIBIOTIC SENSITIVITY; ANTIBIOTIC THERAPY; ANXIETY; ANXIETY DISORDER; ARTICLE; ASPARTATE AMINOTRANSFERASE LEVEL; ASTHENIA; CELLULITIS; CLINICAL OUTCOME; CLOSTRIDIUM DIFFICILE INFECTION; COMBINATION DRUG THERAPY; COMMUNITY ACQUIRED INFECTION; COMORBIDITY; CONSTIPATION; CONTROLLED STUDY; DIABETES MELLITUS; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; ENTEROCOCCUS FAECALIS; ESCHERICHIA COLI; FEMALE; FEVER; FOLLOW UP; HEADACHE; HUMAN; HYPERTENSION; HYPOKALEMIA; HYPOMAGNESEMIA; INFECTION COMPLICATION; INJECTION SITE PHLEBITIS; INSOMNIA; IRON DEFICIENCY ANEMIA; KLEBSIELLA OXYTOCA; KLEBSIELLA PNEUMONIAE; MAJOR CLINICAL STUDY; MALE; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; METHICILLIN SUSCEPTIBLE STAPHYLOCOCCUS AUREUS; MINIMUM INHIBITORY CONCENTRATION; MORGANELLA MORGANII; MULTICENTER STUDY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; NON-INFERIORITY TRIAL; OROPHARYNX PAIN; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PROSPECTIVE STUDY; PROTEUS MIRABILIS; PRURITUS; PSEUDOMONAS AERUGINOSA; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; SKIN ABSCESS; SKIN INFECTION; SOFT TISSUE INFECTION; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS ANGINOSUS; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS PYOGENES; SYSTEMIC INFLAMMATORY RESPONSE SYNDROME; URTICARIA; VOMITING; ADOLESCENT; CLINICAL TRIAL; COMPARATIVE STUDY; COMPLICATION; DOUBLE BLIND PROCEDURE; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; PATHOLOGY; SKIN DISEASES, BACTERIAL; SOFT TISSUE INFECTIONS; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

ADMINISTRATION, INTRAVENOUS; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTI-BACTERIAL AGENTS; AZTREONAM; CEPHALOSPORINS; DOUBLE-BLIND METHOD; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; SKIN DISEASES, BACTERIAL; SOFT TISSUE INFECTIONS; SYSTEMIC INFLAMMATORY RESPONSE SYNDROME; TREATMENT OUTCOME; VANCOMYCIN; YOUNG ADULT;

EID: 85015628298     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dkw333     Document Type: Article

References (33)

1. Edelsberg J, Taneja C, ZervosMet al. Trends in US hospital admissions for skin and soft tissue infections. Emerg Infect Dis 2009; 15: 1516-8
2. Corey GR, Wilcox MH, Talbot GH et al. CANVAS 1: the first Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother 2010; 65 Suppl 4: iv41-iv51
3. Wilcox MH, Corey GR, Talbot GH et al. CANVAS 2: the second Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother 2010; 65 Suppl 4: iv53-iv65
4. Eckmann C, Dryden M. Treatment of complicated skin and soft-tissue infections caused by resistant bacteria: value of linezolid, tigecycline, daptomycin and vancomycin. Eur J Med Res 2010; 15: 554-63
5. AstraZeneca AB. Zinforo 600 mg Powder for Concentrate for Solution for Infusion. Summary of Product Characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002252/WC500132586.pdf
6. Corey GR, Wilcox M, Talbot GH et al. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis 2010; 51: 641-50
7. Corrado ML. Integrated safety summary of CANVAS 1 and 2 trials: Phase III, randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother 2010; 65 Suppl 4: iv67-iv71
8. Flamm RK, Sader HS, Jones RN. Ceftaroline activity tested against contemporary Latin American bacterial pathogens (2011). Braz J Infect Dis 2014; 18: 187-95
9. Flamm RK, Jones RN, Sader HS. In vitro activity of ceftaroline tested against isolates from the Asia-Pacific region and South Africa (2011). J Global Antimicrob Resist 2014; 2: 183-9
10. Castanheira M, Jones RN, Sader HS. Activity of ceftaroline and comparator agents tested against contemporary Gram-positive and-negative (2011) isolates collected in Europe, Turkey, and Israel. J Chemother 2014; 26: 202-10
11. Clinical Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing: Twenty-Third Informational Supplement M100-S23. CLSI, Wayne, PA, USA, 2013
12. The European Committee on Antimicrobial Susceptibility Testing. Breakpoint Tables for Interpretation of MICs and Zone Diameters. Version 5.0, 2015. www.eucast.org/clinical_breakpoints/
13. Pinder M, Bellomo R, Lipman J. Pharmacological principles of antibiotic prescription in the critically ill. Anaesth Intensive Care 2002; 30: 134-44
14. Murray PR, Baron EJ, Jorgensen JH et al. Manual of Clinical Microbiology. Washington, DC: ASM Press, 2007
15. Levine NS, Lindberg RB, Mason AD Jr et al. The quantitative swab culture and smear: a quick, simple method for determining the number of viable aerobic bacteria on open wounds. J Trauma 1976; 16: 89-94
16. Clinical Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically-Ninth Edition: Approved Standard M07-A9. CLSI, Wayne, PA, USA, 2012
17. Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med 1985; 4: 213-26
18. Swanbeck G, Dahlberg E. Cutaneous drug reactions. An attempt to quantitative estimation. Arch Dermatol Res 1992; 284: 215-8
19. Yang L, Sunzel M, Xu P et al. Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese andWestern subjects. Int J Clin Pharmacol Ther 2015; 53: 681-91
20. Diekema DJ, Pfaller MA, Schmitz FJ et al. Survey of infections due to Staphylococcus species: frequency of occurrence and antimicrobial susceptibility of isolates collected in the United States, Canada, Latin America, Europe, and the Western Pacific region for the SENTRY Antimicrobial Surveillance Program, 1997-1999. Clin Infect Dis 2001; 32 Suppl 2: S114-S132
21. Moet GJ, Jones RN, Biedenbach DJ et al. Contemporary causes of skin and soft tissue infections in North America, Latin America, and Europe: report from the SENTRY Antimicrobial Surveillance Program (1998-2004). Diagn Microbiol Infect Dis 2007; 57: 7-13
22. Corey R, Wilcox M, Gonzalez J et al. Ceftaroline fosamil (CPT-F) in patients with acute bacterial skin and skin structure infections (ABSSSI) with systemic inflammatory signs: results across 3 pivotal studies using q8h or q12h. In: Abstracts of the Fifty-fifth Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, CA, USA, 2015. p. L-839. American Society for Microbiology
23. Reiszner E, Ambler J, Iaconis J. Ceftaroline in the treatment of complicated skin and soft tissue infections: in vitro susceptibility of baseline pathogens isolated in a Phase III randomised clinical trial. In: Abstracts of the Twenty-fifth European Congress of Clinical Microbiology and Infection. Copenhagen, Denmark, 2015. p. EV0128. European Society of Clinical Microbiology and Infectious Diseases
24. Zhou D, Dryden M, Gonzalez J et al. Impact of disease severity on ceftaroline pharmacokinetics (PK) in patients with ABSSSI: Phase III COVERS trial. In: Abstracts of the Fifty-fifth Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, CA, USA, 2015. p. A-966. American Society for Microbiology
25. Iaconis J, Critchley I, Zhou D et al. Ceftaroline fosamil 600 mg every 12h (every 12 h) can provide adequate exposure against Staphylococcus aureus with ceftaroline MICs =2mg/L in ABSSSI. In: Abstracts of the Fiftyfifth Interscience Conference on Antimicrobial Agents and Chemotherapy. San Diego, CA, USA, 2015. p. A-456. American Society for Microbiology
26. Das S, Li J, Gonzalez J et al. Ceftaroline fosamil 600mg every 8h for the treatment of ABSSSI due to Staphylococcus aureus with ceftaroline MICs of 4 mg/L. In: Abstracts of the Fifty-fifth Interscience Conference on Antimicrobial Agents and Chemotherapy. San Diego, CA, USA, 2015. p. A-455. American Society for Microbiology
27. Rank DR, Friedland HD, Laudano JB. Integrated safety summary of FOCUS 1 and FOCUS 2 trials: Phase III randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with community-acquired pneumonia. J Antimicrob Chemother 2011; 66 Suppl 3: iii53-iii9
28. Zhong NS, Sun T, Zhuo C et al. Ceftaroline fosamil versus ceftriaxone for the treatment of Asian patients with community-acquired pneumonia: a randomised, controlled, double-blind, phase 3, non-inferiority with nested superiority trial. Lancet Infect Dis 2015; 15: 161-71
29. Dona I, Barrionuevo E, Blanca-Lopez N et al. Trends in hypersensitivity drug reactions: more drugs, more response patterns, more heterogeneity. J Investig Allergol Clin Immunol 2014; 24: 143-53
30. Rodriguez-Pena R, Antunez C, Martin E et al. Allergic reactions to b-lactams. Expert Opin Drug Saf 2006; 5: 31-48
31. Thong BY, Tan TC. Epidemiology and risk factors for drug allergy. Br J Clin Pharmacol 2011; 71: 684-700
32. Andes DR, Craig WA. Cephalosporins. In: Mandell GL, ed. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. Philadelphia: Elsevier Inc., 2005; 294-311
33. Food and Drug Administration, Center for Drug Evaluation Research. Guidance for Industry. Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment. 2013. http://www.fda.gov/downloads/Drugs/./Guidances/ucm071185.pdf