scholarly journals 1240. Ceftobiprole Activity against Drug-Resistant Staphylococcus aureus Clinical Isolates Collected in the United States from 2016 through 2020

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S709-S710
Author(s):  
Leonard R Duncan ◽  
Kamal Hamed ◽  
Jennifer Smart ◽  
Michael A Pfaller ◽  
Helio S Sader
Keyword(s):  
United States ◽  
Staphylococcus Aureus ◽  
Human Services ◽  
The United States ◽  
Services Research ◽  
Health And Human Services ◽  
Highly Active ◽  
Department Of Health ◽  
Medical Centers ◽  
Research Grant

Abstract Background Multidrug-resistant (MDR) and methicillin-resistant Staphylococcus aureus (MRSA) present significant treatment challenges and can cause serious morbidity and mortality. Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced cephalosporin approved in many European and other countries for the treatment of adults with community- and hospital-acquired pneumonia, excluding ventilator-associated pneumonia. Ceftobiprole is currently in phase 3 clinical development to support a New Drug Application in the United States for acute bacterial skin and skin structure infections and S. aureus bacteremia. Here, the activity of ceftobiprole and comparators was evaluated against recent MDR S. aureus and MRSA clinical isolates. Methods 13,868 S. aureus isolates were collected from patients with various infection types at 34 US medical centers from 2016–2020. Susceptibility to ceftobiprole and comparator agents was tested by CLSI methods. Current CLSI and EUCAST interpretive criteria were applied (Table). Isolates were categorized as MDR if they were non-susceptible (NS; CLSI criteria) to ≥3 of the following antimicrobials: clindamycin (CM), daptomycin (DAP), erythromycin (ERY), gentamicin (GM), levofloxacin (LEV), linezolid (LZD), tetracycline (TET), tigecycline (TGC), trimethoprim-sulfamethoxazole (TMP-SMX), or vancomycin (VAN). Isolates displaying oxacillin MIC values ≥4 mg/L were categorized as MRSA. Results Ceftobiprole was more active than ceftaroline (CPT) against MRSA (99.2% susceptible [S] versus 94.0% S, respectively) (Table). Ceftobiprole maintained activity against 88.0% of the CPT-NS isolates, but CPT was only active against 6.5% of the ceftobiprole-NS isolates. Ceftobiprole was also highly active (97.7–100.0% S) against isolates NS to CM, DAP, ERY, GM, LEV, LZD, TET, TGC, or TMP-SMX. No VAN-NS isolates were detected. Importantly, ceftobiprole was more active (97.7% S) than CPT (83.0% S) against the subset of MDR-MRSA isolates. Conclusion Conclusions: Ceftobiprole was highly active in vitro against MRSA and MDR S. aureus collected at US medical centers during 2016–2020. These results support the further development of ceftobiprole to treat S. aureus infections in the US. Disclosures Leonard R. Duncan, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Shionogi (Research Grant or Support) Kamal Hamed, MD, MPH, Basilea Pharmaceutica International, Ltd (Employee)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C) Jennifer Smart, PhD, Basilea Pharmaceutica International, Ltd. (Employee)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C) Michael A Pfaller, MD, Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Pfizer, Inc. (Research Grant or Support) Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support)

scholarly journals 1595. Ceftobiprole Activity against Gram-Positive Pathogens Causing Bone and Joint Infections in the United States from 2016 through 2019

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S794-S794
Author(s):  
Leonard R Duncan ◽  
Kamal Hamed ◽  
Jennifer Smart ◽  
Michael A Pfaller ◽  
Robert K Flamm ◽  
...  
Keyword(s):  
Human Services ◽  
The United States ◽  
Services Research ◽  
Gram Positive ◽  
Health And Human Services ◽  
Highly Active ◽  
Joint Infections ◽  
Department Of Health ◽  
Medical Centers ◽  
Research Grant

Abstract Background Bone and joint infections (BJIs) cause serious morbidity and mortality and present significant treatment challenges. Ceftobiprole medocaril, the prodrug of ceftobiprole, is an advanced cephalosporin approved in many European and non-European countries for the treatment of adults with community- and hospital-acquired pneumonia, excluding ventilator-associated pneumonia. Ceftobiprole medocaril is not approved in the United States (USA) but has qualified infectious disease product (QIDP) status, and is being evaluated in two phase 3 clinical trials in patients with acute bacterial skin and skin structure infections (completed) or Staphylococcus aureus bacteremia (ongoing). In this study, the activity of ceftobiprole and comparators was evaluated against recent Gram-positive clinical isolates collected from BJIs in the USA. Methods 306 Gram-positive pathogens were collected from patients with BJIs at 27 US medical centers from 2016 through 2019. Susceptibility to ceftobiprole and comparator agents was tested using current CLSI methods. CLSI and EUCAST interpretive criteria were applied according to current guidelines. Results The major Gram-positive species and pathogen groups included S. aureus (67.0%; methicillin-resistant S. aureus [MRSA], 35.1%), β-hemolytic streptococci (BHS; 13.7%), coagulase-negative staphylococci (CoNS; 9.5%), and Enterococcus faecalis (6.9%). Ceftobiprole was highly active against S. aureus (MIC50/90 values, 0.5/1 mg/L; 100.0% susceptible by EUCAST criteria), including MRSA (MIC50/90 values, 1/2 mg/L). Ceftobiprole also exhibited potent activity against other Gram-positive cocci, including BHS (MIC50/90 values, 0.015/0.03 mg/L; 100% inhibited at ≤ 4 mg/L, which is the EUCAST PK-PD non-species-related breakpoint), CoNS (MIC50/90 values, 1/4 mg/L; 100% inhibited at ≤4 mg/L), and E. faecalis (MIC50/90 values, 0.5/2 mg/L; 100.0% inhibited at ≤ 4 mg/L). Conclusion Ceftobiprole was highly active against clinical BJI isolates from the major Gram-positive pathogen groups collected at US medical centers during 2016–2019. The broad-spectrum activity of ceftobiprole, including potent activity against MRSA, supports its further evaluation for this potential indication. Disclosures Leonard R. Duncan, PhD, A. Menarini Industrie Farmaceutiche Riunite S.R.L. (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Dept of Health and Human Services (Research Grant or Support) Kamal Hamed, n/a, Basilea Pharmaceutica International Ltd. (Employee) Jennifer Smart, PhD, Basilea Pharmaceutica International, Ltd (Employee)Department of Health and Human Services (Research Grant or Support) Michael A. Pfaller, MD, Amplyx Pharmaceuticals (Research Grant or Support)Basilea Pharmaceutica International, Ltd (Research Grant or Support)Cidara Therapeutics (Research Grant or Support)Cidara Therapeutics (Research Grant or Support)Department of Health and Human Services (Research Grant or Support)Fox Chase Chemical Diversity Center (Research Grant or Support)Paratek Pharma, LLC (Research Grant or Support) Robert K. Flamm, PhD, A. Menarini Industrie Farmaceutiche Riunite S.R.L. (Research Grant or Support)Amplyx Pharmaceuticals (Research Grant or Support)Basilea Pharmaceutica International, Ltd (Research Grant or Support)Department of Health and Human Services (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support) Rodrigo E. Mendes, PhD, A. Menarini Industrie Farmaceutiche Riunite S.R.L. (Research Grant or Support)Allergan (Research Grant or Support)Allergan (Research Grant or Support)Basilea Pharmaceutica International, Ltd (Research Grant or Support)Cipla Ltd. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Merck (Research Grant or Support)Merck (Research Grant or Support)Pfizer (Research Grant or Support)

Letter to the Editor

PEDIATRICS ◽  
1994 ◽  
Vol 94 (6) ◽  
pp. 952-954
Author(s):  
Martin S. Robinette
Keyword(s):  
United States ◽  
Hearing Loss ◽  
Hearing Impairment ◽  
Early Identification ◽  
Human Services ◽  
Large Degree ◽  
The United States ◽  
Healthy People ◽  
Health And Human Services ◽  
Department Of Health

The importance of early identification of hearing loss is summarized in the report issued by the United States (US) Department of Health and Human Services,1 entitled "Healthy People 2000." The goal is to reduce the average age at which children with significant hearing impairment are identified to no more than 12 months. The report states: The future of a child born with significant hearing impairment depends to a very large degree on early identification (ie, audiological diagnosis before 12 months of age) followed by immediate and appropriate intervention.

scholarly journals Interpersonal influence among public health leaders in the United States Department of Health and Human Services

2012 ◽  
Vol 1 (1) ◽  
pp. 12 ◽  
Author(s):  
Jenine K. Harris ◽  
Bobbi J. Carothers ◽  
Lana M. Wald ◽  
Sarah C. Shelton ◽  
Scott J. Leischow
Keyword(s):  
Public Health ◽  
United States ◽  
Tobacco Control ◽  
Human Services ◽  
The United States ◽  
United States Department ◽  
Interpersonal Influence ◽  
States Department ◽  
Health And Human Services ◽  
Department Of Health

<em>Background</em>. In public health, interpersonal influence has been identified as an important factor in the spread of health information, and in understanding and changing health behaviors. However, little is known about influence in public health leadership. Influence is important in leadership settings, where public health professionals contribute to national policy and practice agendas. Drawing on social theory and recent advances in statistical network modeling, we examined influence in a network of tobacco control leaders at the United States Department of Health and Human Services (DHHS). <em>Design and Methods.</em> Fifty-four tobacco control leaders across all 11 agencies in the DHHS were identified; 49 (91%) responded to a web-based survey. Participants were asked about communication with other tobacco control leaders, who influenced their work, and general job characteristics. Exponential random graph modeling was used to develop a network model of influence accounting for characteristics of individuals, their relationships, and global network structures. <em>Results</em>. Higher job ranks, more experience in tobacco control, and more time devoted to tobacco control each week increased the likelihood of influence nomination, as did more frequent communication between network members. Being in the same agency and working the same number of hours per week were positively associated with mutual influence nominations. Controlling for these characteristics, the network also exhibited patterns associated with influential clusters of network members. <em>Conclusions</em>. Findings from this unique study provide a perspective on influence within a government agency that both helps to understand decision-making and also can serve to inform organizational efforts that allow for more effective structuring of leadership.

Globalization of Clinical Research by the Pharmaceutical Industry

2003 ◽  
Vol 33 (1) ◽  
pp. 29-36 ◽  
Author(s):  
Sonia Shah
Keyword(s):  
United States ◽  
Human Services ◽  
The United States ◽  
Class Action ◽  
Ethical Standards ◽  
Health And Human Services ◽  
Department Of Health ◽  
Drug Companies ◽  
The Subject ◽  
The U.S

Drug companies' quest for speedy results has led to a boom in trials based in developing countries, where ethical standards may be lax and the impoverished sick abundant. According to the U.S. Department of Health and Human Services Inspector General's office, the number of researchers based outside the United States seeking new drug approvals has increased 16-fold over the last decade. In this article, a 1996 Pfizer trial in Nigeria—the subject of a controversial class-action suit—illustrates the dangers.

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