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Haiying Sun, Lillian Ting, Surendra Machineni, Jens Praestgaard, Andreas Kuemmell, Daniel S Stein, Gangadhar Sunkara, Steven J Kovacs, Stephen Villano, S Ken Tanaka
Omadacycline is a first in class aminomethylcycline antibiotic with microbiological activity against Gram-positive and Gram-negative aerobes and anaerobes, and atypical bacteria that is being developed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The bioavailability of a Phase 3 tablet formulation relative to intravenous (IV) administration (and of other oral formulations relative to the Phase 3 tablet) was investigated in an open-label, randomized, four-period, crossover study in healthy subjects age 18-50 years...
October 10, 2016: Antimicrobial Agents and Chemotherapy
G Ralph Corey, Francis F Arhin, Matthew A Wikler, Daniel F Sahm, Barry N Kreiswirth, José R Mediavilla, Samantha Good, Claude Fiset, Hai Jiang, Greg Moeck, Heidi Kabler, Sinikka Green, William O'Riordan
Oritavancin is a lipoglycopeptide antibiotic with bactericidal activity against Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). The phase 3 studies SOLO I and SOLO II demonstrated comparable efficacy and safety of a single dose of oritavancin compared with 7-10 days of twice-daily vancomycin in adults with acute bacterial skin and skin-structure infections (ABSSSIs). The present analysis assessed clinical responses by pathogen at 48-72 h and at study days 14-24 in SOLO patients within the pooled data set...
September 13, 2016: International Journal of Antimicrobial Agents
John A Bosso, Anthony M Casapao, Jonathan Edwards, Kenneth Klinker, Christopher McCoy, David P Nicolau, Katherine K Perez, Andrew Marcarelli, Deeksha Dua
This article was written with the aim to establish a consensus clinical pathway for long-acting lipoglycopeptide antibiotics such as oritavancin (Orbactiv®) and dalbavancin (Dalvance®) for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Seven infectious diseases pharmacy specialists from a variety of facilities across the United States (US) participated in a roundtable discussion to consider the use of newer single-dose long-acting lipoglycopeptides, and integrate them into clinical pathways for ABSSSI...
October 2016: Hospital Practice (Minneapolis)
Warren S Joseph, Darren Culshaw, Steven Anuskiewicz, Carisa De Anda, Philippe Prokocimer
BACKGROUND: Tedizolid phosphate, the prodrug of the oxazolidinone tedizolid, has been approved in a number of countries, including the United States, those in the European Union, and Canada, for treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Two Phase 3 trials demonstrated the noninferior efficacy of tedizolid (200 mg once daily for 6 days) to linezolid (600 mg twice daily for 10 days) in patients with ABSSSI. Because of the challenges of treating lower-extremity ABSSSI, the efficacy and safety of tedizolid and linezolid for treating lower extremity versus non-lower extremity infections were compared...
August 17, 2016: Journal of the American Podiatric Medical Association
John H Powers, Anita F Das, Carisa De Anda, Philippe Prokocimer
OBJECTIVES: Outcome assessments as clinical trial endpoints should be well-defined, reliable, and reflect meaningful treatment benefits. For acute bacterial skin and skin structure infections (ABSSSI) trials, recent recommendations suggest a primary endpoint of reduction in skin lesion area. Objectives were: evaluate ABSSSI lesion area measurement reliability, evaluate impact of various lesion area definitions on treatment effect size, and explore relationships between lesion area and pain...
September 2016: Contemporary Clinical Trials
Manjunath P Pai
PURPOSE: Obesity is recognized to be a risk factor for acute bacterial skin and skin structure infections (ABSSSIs) that are associated with methicillin-resistant Staphylococcus aureus (MRSA). Several new antimicrobial agents have been introduced to treat MRSA-related ABSSSI and are dosed with and without regard to weight. This review seeks to explain the pharmacokinetic and pharmacodynamic (PK-PD) rationale for initial and maintenance dosage selection of these newer agents in obese adults...
September 2016: Clinical Therapeutics
Todd A Riccobene, Tatiana Khariton, William Knebel, Shampa Das, James Li, Alena Jandourek, Timothy J Carrothers, John S Bradley
Ceftaroline, the active form of the pro-drug ceftaroline fosamil, is approved for use in adults with community-acquired bacterial pneumonia (CABP) or acute bacterial skin and skin structure infections (ABSSSI) in the United States and similar indications in Europe. Pharmacokinetic (PK) data from five pediatric (birth to <18 years) studies of ceftaroline fosamil were combined with PK data from adults to update a population PK model for ceftaroline and ceftaroline fosamil. This model, based on a dataset including 305 children, was used to conduct simulations to estimate ceftaroline exposures and percentage of time that free drug concentrations were above the minimum inhibitory concentration (%fT>MIC) for pediatric dose regimens...
August 11, 2016: Journal of Clinical Pharmacology
S Ken Tanaka, Judith Steenbergen, Stephen Villano
Omadacycline is novel, aminomethyl tetracycline antibiotic being developed for oral and intravenous (IV) administration for the treatment of community-acquired bacterial infections. Omadacycline is characterized by an aminomethyl substituent at the C9 position of the core 6-member ring. Modifications at this position result in an improved spectrum of antimicrobial activity by overcoming resistance known to affect older generation tetracyclines via ribosomal protection proteins and efflux pump mechanisms. In vitro, omadacycline has activity against Gram-positive and Gram-negative aerobes, anaerobes, and atypical pathogens including Legionella and Chlamydia spp...
July 18, 2016: Bioorganic & Medicinal Chemistry
Vien T M Le, Christine Tkaczyk, Sally Chau, Renee L Rao, Etyene Castro Dip, Eliane P Pereira-Franchi, Lily Cheng, Sally Lee, Holly Koelkebeck, Jamese J Hilliard, Xiang Qing Yu, Vivekananda Datta, Vien Nguyen, William Weiss, Laszlo Prokai, Terrence O'Day, C Kendall Stover, Bret R Sellman, Binh An Diep
Methicillin-resistant Staphylococcus aureus (MRSA) causes large-scale epidemics of acute bacterial skin and skin structure infections (ABSSSI) within communities across the United States. Animal models that reproduce ABSSSI as they occur in humans are urgently needed to test new therapeutic strategies. Alpha-toxin plays a critical role in a variety of staphylococcal infection models in mice, but its role in the pathogenesis of ABSSSI remains to be elucidated in rabbits, which are similar to humans in their susceptibility to S...
October 2016: Antimicrobial Agents and Chemotherapy
Daniel H Deck, Jennifer M Jordan, Thomas L Holland, Weihong Fan, Matthew A Wikler, Katherine A Sulham, G Ralph Corey
INTRODUCTION: Introduction of new antibiotics enabling single-dose administration, such as oritavancin may significantly impact site of care decisions for patients with acute bacterial skin and skin structure infections (ABSSSI). This analysis compared the efficacy of single-dose oritavancin with multiple-dose vancomycin in patients categorized according to disease severity via modified Eron classification and management setting. METHODS: SOLO I and II were phase 3 studies evaluating single-dose oritavancin versus 7-10 days of vancomycin for treatment of ABSSSI...
September 2016: Infectious Diseases and Therapy
Travis M Jones, Steven W Johnson, V Paul DiMondi, Dustin T Wilson
JNJ-Q2 is a novel, fifth-generation fluoroquinolone that has excellent in vitro and in vivo activity against a variety of Gram-positive and Gram-negative organisms. In vitro studies indicate that JNJ-Q2 has potent activity against pathogens responsible for acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP), such as Staphylococcus aureus and Streptococcus pneumoniae. JNJ-Q2 also has been shown to have a higher barrier to resistance compared to other agents in the class and it remains highly active against drug-resistant organisms, including methicillin-resistant S...
2016: Infection and Drug Resistance
Kimberly D Leuthner, Kristin A Buechler, David Kogan, Agafe Saguros, H Stephen Lee
Acute bacterial skin and skin structure infections (ABSSSI) are a common disease causing patients to seek treatment through the health care system. With the continued increase of drug-resistant bacterial pathogens, these infections are becoming more difficult to successfully cure. Lipoglycopeptides have unique properties that allow the drug to remain active toward both common and challenging pathogens at the infected site for lengthy periods of time. Dalbavancin, a new lipoglycopeptide, provides two unique dosing regimens for the treatment of ABSSSI...
2016: Therapeutics and Clinical Risk Management
Norihito Kaku, Yoshitomo Morinaga, Kazuaki Takeda, Kosuke Kosai, Naoki Uno, Hiroo Hasegawa, Taiga Miyazaki, Koichi Izumikawa, Hiroshi Mukae, Katsunori Yanagihara
Tedizolid (TZD) is a second-generation oxazolidinone and demonstrates potent in-vitro activity against multidrug-resistant Gram-positive bacteria. Phase III studies in patients with acute bacterial skin and skin structure infections (ABSSSI) have demonstrated the non-inferiority of TZD to linezolid (LZD). However, there are only a few studies that show the effect of TZD in pulmonary infections. In this study, we investigated the effect of TZD in a murine model of hematogenous pulmonary infection caused by methicillin-resistant Staphylococcus aureus (MRSA)...
September 2016: International Journal of Medical Microbiology: IJMM
Jaime E Verastegui, Yukihiro Hamada, David P Nicolau
Acute bacterial skin and skin structure infections (ABSSSI) have evolved over a relatively short period of time to become one of the most challenging medical problems encountered in clinical practice. Notably the high incidence of methicillin-resistant S. aureus (MRSA) across the continuum of care has coincided with increased outpatient failures and higher rates of hospital admissions for parental antibiotic therapy. Consequently the management of ABSSSI constitutes a tremendous burden to the healthcare system in terms of cost of care and consumption of institutional and clinical resources...
August 2016: Expert Review of Clinical Pharmacology
Ivar S Jensen, Elizabeth Wu, Weihong Fan, Thomas P Lodise, David P Nicolau, Scott Dufour, Philip L Cyr, Katherine A Sulham
BACKGROUND: It is estimated that acute bacterial skin and skin structure infections (ABSSSI) account for nearly 10% of hospital admissions and 3.4-3.8 million emergency department visits per year in the United States. Analyses of hospital discharge records indicate 74% of ABSSSI admissions involve empiric treatment with methicillin-resistant Staphylococcus aureus (MRSA) active antibiotics. Analysis has shown that payer costs could be reduced if moderate-to-severe ABSSSI patients were treated to a greater extent in the observational unit followed by discharge to outpatient parenteral antibiotic therapy (OPAT)...
June 2016: Journal of Managed Care & Specialty Pharmacy
Rosanna Li, Michael D Nailor
The FDA guidance published in 2013 provided requirements for conducting ABSSSI trials. In 2014, dalbavancin, oritavancin, and tedizolid were introduced into the market after phase III noninferiority clinical trials against vancomycin (for the lipoglycopeptides) and linezolid (for tedizolid), demonstrating clinical efficacy for the treatment of ABSSSI. Great interest exists for these agents because of the postulated financial impact. Due to favorable pharmacokinetics which allow for less frequent medication administration and shorter treatment durations, these agents may prove to reduce hospital admissions and length of stay...
March 2016: Connecticut Medicine
Bartosz Korczowski, Tinatin Antadze, Manana Giorgobiani, Martin E Stryjewski, Alena Jandourek, Alexander Smith, Tanya O'Neal, John S Bradley
BACKGROUND: Ceftaroline has in vitro activity against bacterial isolates, including methicillin-resistant Staphylococcus aureus. This is the first study to investigate ceftaroline fosamil in pediatric patients with acute bacterial skin and skin structure infections (ABSSSIs). METHODS: A multicenter, observer-blinded study (NCT01400867) in pediatric patients (2 months-17 years of age) with ABSSSIs. Patients were randomized 2:1 to receive intravenous (IV) ceftaroline fosamil or IV comparator (vancomycin or cefazolin, plus optional aztreonam) with optional switch to oral antibacterials from Day 4...
August 2016: Pediatric Infectious Disease Journal
A Russo, E Concia, F Cristini, F G De Rosa, S Esposito, F Menichetti, N Petrosillo, M Tumbarello, M Venditti, P Viale, C Viscoli, M Bassetti
In 2013 the US Food and Drug Administration (FDA) issued recommendations and guidance on developing drugs for treatment of skin infection using a new definition of acute bacterial skin and skin-structure infection (ABSSSI). The new classification includes cellulitis, erysipelas, major skin abscesses and wound infection with a considerable extension of skin involvement, clearly referring to a severe subset of skin infections. The main goal of the FDA was to better identify specific infections where the advantages of a new antibiotic could be precisely estimated through quantifiable parameters, such as improvement of the lesion size and of systemic signs of infection...
April 2016: Clinical Microbiology and Infection
Muzaffar Iqbal
Tedizolid (TDZ) is a novel oxazolidinone class antibiotic, indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. In this study a highly sensitive UPLC-MS/MS assay was developed and validated for the determination of TDZ in rat plasma using rivaroxaban as an internal standard (IS). Both TDZ and IS were separated on Acquity UPLC BEH(TM) C18 column using isocratic mobile phase comprising of acetonitrile: 20 mM ammonium acetate (85:15, v/v), eluted at 0.3 mL/min flow rate...
April 23, 2016: Biomedical Chromatography: BMC
Marco Falcone, Ercole Concia, Massimo Giusti, Antonino Mazzone, Claudio Santini, Stefania Stefani, Francesco Violi
Skin and soft tissue infections (SSTIs) are a common cause of hospital admission among elderly patients, and traditionally have been divided into complicated and uncomplicated SSTIs. In 2010, the FDA provided a new classification of these infections, and a new category of disease, named acute bacterial skin and skin structure infections (ABSSSIs), has been proposed as an independent clinical entity. ABSSSIs include three entities: cellulitis and erysipelas, wound infections, and major cutaneous abscesses This paper revises the epidemiology of SSTIs and ABSSSIs with regard to etiologies, diagnostic techniques, and clinical presentation in the hospital settings...
August 2016: Internal and Emergency Medicine
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