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Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials.
J Glob Antimicrob Resist. 2022 03; 28:108-114.JG

Abstract

OBJECTIVES

This exploratory pooled analysis assessed the efficacy and safety of ceftaroline fosamil and comparators across six phase III clinical trials in adults with community-acquired pneumonia (CAP) or complicated skin and soft-tissue infection (cSSTI) and secondary bacteraemia.

METHODS

In each trial, FOCUS 1 and 2 (CAP), Asia CAP trial, CANVAS 1 and 2 (cSSTI) and COVERS (cSSTI), patients were randomised to ceftaroline fosamil [600 mg q12h by 1-h i.v. infusion, except in COVERS (600 mg q8h by 2-h i.v. infusion), adjusted for renal function] or comparator. Efficacy assessments included clinical and microbiological responses at test-of-cure visit [microbiological modified intent-to-treat (mMITT) population]. Safety outcomes were assessed.

RESULTS

The pooled mMITT population comprised 1976 patients, of whom 138 had baseline bacteraemia (ceftaroline fosamil, n = 72; comparator, n = 66). Predominant baseline blood pathogens were Staphylococcus aureus (n = 29), Streptococcus pneumoniae (n = 19) and other streptococci (n = 12). Clinical cure rates in bacteraemic patients were 55/72 (76.4%) and 51/66 (77.3%) for ceftaroline fosamil and comparators, respectively, and in non-bacteraemic patients were 822/966 (85.1%) and 717/872 (82.2%). Favourable microbiological response rates in bacteraemic patients were 56/72 (77.8%) for ceftaroline fosamil and 54/66 (81.8%) for comparators, and in non-bacteraemic patients were 825/966 (85.4%) and 719/872 (82.5%). Adverse events in bacteraemic patients were consistent with the known ceftaroline fosamil safety profile or the underlying indications.

CONCLUSION

These pooled clinical and microbiological efficacy data demonstrate generally favourable outcomes for ceftaroline fosamil in patients with CAP or cSSTI and secondary bacteraemia. [Trial Registration: NCT00621504, NCT00509106; NCT01371838; NCT00424190, NCT00423657; NCT01499277].

Authors+Show Affiliations

Royal Hampshire County Hospital, Romsey Road, Winchester SO22 5DG, UK. Electronic address: Matthew.Dryden@phe.gov.uk.Pfizer, Paris, France.Pfizer, New York, New York, USA.Pfizer, Groton, Connecticut, USA.Pfizer, Collegeville, Pennsylvania, USA.Leeds Teaching Hospitals and University of Leeds, Leeds, UK.

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

34922058

Citation

Dryden, Matthew, et al. "Treatment Outcomes of Secondary Bacteraemia in Patients Treated With Ceftaroline Fosamil: Pooled Results From Six Phase III Clinical Trials." Journal of Global Antimicrobial Resistance, vol. 28, 2022, pp. 108-114.
Dryden M, Kantecki M, Yan JL, et al. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022;28:108-114.
Dryden, M., Kantecki, M., Yan, J. L., Stone, G. G., Leister-Tebbe, H., & Wilcox, M. (2022). Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. Journal of Global Antimicrobial Resistance, 28, 108-114. https://doi.org/10.1016/j.jgar.2021.10.027
Dryden M, et al. Treatment Outcomes of Secondary Bacteraemia in Patients Treated With Ceftaroline Fosamil: Pooled Results From Six Phase III Clinical Trials. J Glob Antimicrob Resist. 2022;28:108-114. PubMed PMID: 34922058.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. AU - Dryden,Matthew, AU - Kantecki,Michal, AU - Yan,Jean Li, AU - Stone,Gregory G, AU - Leister-Tebbe,Heidi, AU - Wilcox,Mark, Y1 - 2021/12/16/ PY - 2021/04/13/received PY - 2021/10/06/revised PY - 2021/10/30/accepted PY - 2021/12/19/pubmed PY - 2022/5/6/medline PY - 2021/12/18/entrez KW - Bloodstream infection KW - Ceftaroline fosamil KW - Community-acquired pneumonia KW - Complicated skin and soft-tissue infection KW - Secondary bacteraemia SP - 108 EP - 114 JF - Journal of global antimicrobial resistance JO - J Glob Antimicrob Resist VL - 28 N2 - OBJECTIVES: This exploratory pooled analysis assessed the efficacy and safety of ceftaroline fosamil and comparators across six phase III clinical trials in adults with community-acquired pneumonia (CAP) or complicated skin and soft-tissue infection (cSSTI) and secondary bacteraemia. METHODS: In each trial, FOCUS 1 and 2 (CAP), Asia CAP trial, CANVAS 1 and 2 (cSSTI) and COVERS (cSSTI), patients were randomised to ceftaroline fosamil [600 mg q12h by 1-h i.v. infusion, except in COVERS (600 mg q8h by 2-h i.v. infusion), adjusted for renal function] or comparator. Efficacy assessments included clinical and microbiological responses at test-of-cure visit [microbiological modified intent-to-treat (mMITT) population]. Safety outcomes were assessed. RESULTS: The pooled mMITT population comprised 1976 patients, of whom 138 had baseline bacteraemia (ceftaroline fosamil, n = 72; comparator, n = 66). Predominant baseline blood pathogens were Staphylococcus aureus (n = 29), Streptococcus pneumoniae (n = 19) and other streptococci (n = 12). Clinical cure rates in bacteraemic patients were 55/72 (76.4%) and 51/66 (77.3%) for ceftaroline fosamil and comparators, respectively, and in non-bacteraemic patients were 822/966 (85.1%) and 717/872 (82.2%). Favourable microbiological response rates in bacteraemic patients were 56/72 (77.8%) for ceftaroline fosamil and 54/66 (81.8%) for comparators, and in non-bacteraemic patients were 825/966 (85.4%) and 719/872 (82.5%). Adverse events in bacteraemic patients were consistent with the known ceftaroline fosamil safety profile or the underlying indications. CONCLUSION: These pooled clinical and microbiological efficacy data demonstrate generally favourable outcomes for ceftaroline fosamil in patients with CAP or cSSTI and secondary bacteraemia. [Trial Registration: NCT00621504, NCT00509106; NCT01371838; NCT00424190, NCT00423657; NCT01499277]. SN - 2213-7173 UR - https://www.unboundmedicine.com/medline/citation/34922058/Treatment_outcomes_of_secondary_bacteraemia_in_patients_treated_with_ceftaroline_fosamil:_pooled_results_from_six_phase_III_clinical_trials_ DB - PRIME DP - Unbound Medicine ER -