Literature DB >> 30202941

Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults.

Thomas L Holland1, Henry F Chambers2, Helen W Boucher3, G Ralph Corey1, Rebecca Coleman4, Bibiana Castaneda-Ruiz4, Vance G Fowler1.   

Abstract

Clinical trials for Staphylococcus aureus bloodstream infections (SAB) are broadly grouped into 2 categories: registrational trials intended to support regulatory approval of antibiotics for the treatment of SAB and strategy trials intended to inform clinicians on the best treatment options for SAB among existing antibiotics. Both types of SAB trials are urgently needed but have been limited by cost, complexity, and regulatory uncertainty. Here, we review key SAB trial design considerations for investigators, sponsors, and regulators.
© The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Entities:  

Keywords:  zzm321990 Staphylococcus aureuszzm321990 ; bacteremia; clinical trials

Year:  2019        PMID： 30202941      PMCID： PMC6376080          DOI： 10.1093/cid/ciy774

Source DB:  PubMed          Journal:  Clin Infect Dis        ISSN： 1058-4838            Impact factor:   9.079


  16 in total

1.  Interleukin (IL)-1β and IL-10 Host Responses in Patients With Staphylococcus aureus Bacteremia Determined by Antimicrobial Therapy.

Authors:  Cecilia F Volk; Sarah Burgdorf; Graham Edwardson; Victor Nizet; George Sakoulas; Warren E Rose
Journal:  Clin Infect Dis       Date:  2020-06-10       Impact factor: 9.079

2.  Efficacy of Early Oral Switch with β-Lactams for Low-Risk Staphylococcus aureus Bacteremia.

Authors:  Olivia Bupha-Intr; Tim Blackmore; Max Bloomfield
Journal:  Antimicrob Agents Chemother       Date:  2020-06-23       Impact factor: 5.191

3.  Exebacase for patients with Staphylococcus aureus bloodstream infection and endocarditis.

Authors:  Vance G Fowler; Anita F Das; Joy Lipka-Diamond; Raymond Schuch; Roger Pomerantz; Luis Jáuregui-Peredo; Adam Bressler; David Evans; Gregory J Moran; Mark E Rupp; Robert Wise; G Ralph Corey; Marcus Zervos; Pamela S Douglas; Cara Cassino
Journal:  J Clin Invest       Date:  2020-07-01       Impact factor: 14.808

4.  A Phase 1, Randomized, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S, an Anti-Staphylococcus aureus Thiomab Antibody-Antibiotic Conjugate, in Healthy Volunteers.

Authors:  Melicent Peck; Michael E Rothenberg; Rong Deng; Nicholas Lewin-Koh; Gaohong She; Amrita V Kamath; Montserrat Carrasco-Triguero; Ola Saad; Aide Castro; Lisa Teufel; Daniel S Dickerson; Marisa Leonardelli; Jorge A Tavel
Journal:  Antimicrob Agents Chemother       Date:  2019-05-24       Impact factor: 5.191

5.  The Effectiveness of Combination Therapy for Treating Methicillin-Susceptible Staphylococcus aureus Bacteremia: A Systematic Literature Review and a Meta-Analysis.

Authors:  Sara Grillo; Mireia Puig-Asensio; Marin L Schweizer; Guillermo Cuervo; Isabel Oriol; Miquel Pujol; Jordi Carratalà
Journal:  Microorganisms       Date:  2022-04-20

6.  Early Oral Antibiotic Switch for Staphylococcus aureus Bacteremia: Many Are Called, but Few Are Chosen.

Authors:  Thomas L Holland
Journal:  Antimicrob Agents Chemother       Date:  2020-06-23       Impact factor: 5.191

7.  Comparative Effectiveness of Switching to Daptomycin Versus Remaining on Vancomycin Among Patients With Methicillin-resistant Staphylococcus aureus (MRSA) Bloodstream Infections.

Authors:  Marin L Schweizer; Kelly Richardson; Mary S Vaughan Sarrazin; Michihiko Goto; Daniel J Livorsi; Rajeshwari Nair; Bruce Alexander; Brice F Beck; Michael P Jones; Mireia Puig-Asensio; Daniel Suh; Madeline Ohl; Eli N Perencevich
Journal:  Clin Infect Dis       Date:  2021-01-29       Impact factor: 9.079

8.  Prognostic Power of Pathogen Cell-Free DNA in Staphylococcus aureus Bacteremia.

Authors:  Alessander O Guimaraes; Johnny Gutierrez; Stacey A Maskarinec; Yi Cao; Kyu Hong; Felicia Ruffin; Montserrat Carrasco-Triguero; Melicent C Peck; Vance G Fowler; Amos Baruch; Carrie M Rosenberger
Journal:  Open Forum Infect Dis       Date:  2019-03-15       Impact factor: 3.835

9.  Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial.

Authors:  Kamal Hamed; Marc Engelhardt; Mark E Jones; Mikael Saulay; Thomas L Holland; Harald Seifert; Vance G Fowler
Journal:  Future Microbiol       Date:  2020-01-10       Impact factor: 3.165

Review 10.  A case study on Staphylococcus aureus bacteraemia: available treatment options, antibiotic R&D and responsible antibiotic-use strategies.

Authors:  Annelie A Monnier; Evelina Tacconelli; Christine Årdal; Marco Cavaleri; Inge C Gyssens
Journal:  JAC Antimicrob Resist       Date:  2020-06-19
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