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Thomas L Holland, William O'Riordan, Alison McManus, Elliot Shin, Ali Borghei, Thomas M File, Mark H Wilcox, Antoni Torres, Matthew Dryden, Thomas Lodise, Toyoko Oguri, G Ralph Corey, Patrick McLeroth, Rajesh Shukla, David B Huang
Iclaprim is a novel diaminopyrimidine antibiotic that may be an effective and safe treatment for serious skin infections. The safety and effectiveness of iclaprim were assessed in a global Phase 3, double-blind, randomized, active-controlled trial. Six-hundred thirteen adults with acute bacterial skin and skin structure infections (ABSSSI) suspected or confirmed to be due to Gram-positive pathogens were randomized to iclaprim (80 mg) or vancomycin (15mg/kg), both administered intravenously every 12 hours for 5 - 14 days...
March 12, 2018: Antimicrobial Agents and Chemotherapy
William O'Riordan, Alison McManus, Juri Teras, Ivan Poromanski, Maria Cruz-Saldariagga, Megan Quintas, Laura Lawrence, ShuJui Liang, Sue Cammarata
Background: Delafloxacin is an IV/oral anionic fluoroquinolone with activity against Gram-positive (including MRSA), Gram-negative, atypical and anaerobic organisms. It is approved in the US for acute bacterial skin and skin structure infections caused by designated susceptible Gram-positive and Gram-negative organisms, and is in development for the treatment of community-acquired bacterial pneumonia. Methods: A multicenter, randomized, double-blind trial of 850 adults with ABSSSI compared delafloxacin 300 mg IV Q12h for 3 days with a switch to 450 mg oral delafloxacin, to vancomycin 15 mg/kg IV with aztreonam for 5-14 days...
March 6, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Neil J Turco, Sandra L Kane-Gill, Inmaculada Hernandez, Louise-Marie Oleksiuk, Frank D'Amico, Aaron J Pickering
INTRODUCTION: Acute bacterial skin and skin-structure infections (ABSSSI) are common infectious diseases (ID) that often require intravenous (IV) antibiotics. Dalbavancin is a novel lipoglycopeptide antibiotic administered once that is FDA-approved for the treatment of ABSSSI. No literature is available for real-world cost-comparability relative to conventional therapy. METHODS: This retrospective chart review examined adults diagnosed with ABSSSI and treated with IV antibiotics at an outpatient ID clinic after hospital discharge from January 2015 to August 2016...
March 2018: Expert Opinion on Pharmacotherapy
Bryan T Mogle, Jeffrey M Steele, Stephen J Thomas, KarenBeth H Bohan, Wesley D Kufel
Delafloxacin is a novel anionic fluoroquinolone (FQ) approved for treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by a number of Gram-positive and Gram-negative organisms including MRSA and Pseudomonas aeruginosa. The unique chemical structure of delafloxacin renders it a weak acid and results in increased potency in acidic environments. In Phase III studies, delafloxacin had similar outcomes to comparator regimens for treatment of ABSSSIs, and was well tolerated overall. Similar to other FQs, delafloxacin is available in both intravenous and oral formulations, but differs in that delafloxacin exerts a minimal effect on cytochrome P450 enzymes and on the corrected QT interval...
February 7, 2018: Journal of Antimicrobial Chemotherapy
Carisa De Anda, Steven Anuskiewicz, Philippe Prokocimer, Jose Vazquez
BACKGROUND: Acute bacterial skin and skin structure infections (ABSSSI) are a frequent cause of hospital admissions in the United States. Safe and effective outpatient treatments may lower ABSSSI-associated health care costs by reducing unnecessary hospital admissions. Using data from 2 phase 3 trials (ESTABLISH-1, NCT01170221; ESTABLISH-2, NCT01421511), this post-hoc analysis explored the efficacy and safety of tedizolid in an outpatient setting. METHODS: Subgroup analysis was performed on US outpatients (defined as patients who were not in hospital at the time of treatment initiation) with ABSSSI caused by presumed or proven gram-positive pathogens...
December 2017: Medicine (Baltimore)
G Ralph Corey, Jeffery Loutit, Greg Moeck, Matthew Wikler, Michael N Dudley, William O'Riordan
Oritavancin is a lipoglycopeptide with bactericidal activity against gram-positive organisms. Its rapid concentration-dependent bactericidal activity and long elimination half-life allow for single dose treatment of acute bacterial skin and skin structure infections (ABSSSI). SOLO I and SOLO II were randomized, double-blind studies evaluating efficacy and safety of a single 1200 mg IV dose of oritavancin versus twice-daily IV vancomycin for 7 to 10 days in ABSSSI patients. Safety data were pooled across both studies for safety analysis...
January 22, 2018: Antimicrobial Agents and Chemotherapy
Silvia Corcione, Francesco Giuseppe De Rosa
PURPOSE OF REVIEW: To summarize the current finding on SSTIs/ABSSSIs treatment duration. RECENT FINDINGS: In 2013, the FDA approved the definition of acute bacterial skin and skin structure infections (ABSSSIs). From a clinical point of view, the new definition may present some advantages: the definition of the severity of the disease, the measurement of reduction in lesion size, and effectiveness of treatment primary endpoint at 48-72 h after treatment initiation...
April 2018: Current Opinion in Infectious Diseases
David B Huang, William O'Riordan, J Scott Overcash, Barry Heller, Faisal Amin, Thomas M File, Mark H Wilcox, Antoni Torres, Matthew Dryden, Thomas L Holland, Patrick McLeroth, Rajesh Shukla, G Ralph Corey
Background: Our objective in this study was to demonstrate the safety and efficacy of iclaprim compared with vancomycin for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSIs). Methods: REVIVE-1 was a phase 3, 600-patient, double-blinded, randomized (1:1), active-controlled trial among patients with ABSSSI that compared the safety and efficacy of iclaprim 80 mg fixed dose with vancomycin 15 mg/kg, both administered intravenously every 12 hours for 5-14 days...
December 21, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
M Galluzzo, S D'Adamio, L Bianchi, M Talamonti
Acute bacterial skin and skin structure infections (ABSSIs), defined as a bacterial infection of the skin with a lesion size area of at least 75 cm, are a leading cause of hospital admission and ambulatory care visits worldwide. Dalbavancin is a lipoglycopeptide antibiotic recently approved by the United States Food and Drug Administration (FDA) and by European Medicines Agency (EMA) for ABSSSIs. The authors review and provide updates of efficacy and safety by several studies on dalbavancin. Areas covered: A PubMed search was performed for relevant literature...
December 20, 2017: Expert Opinion on Drug Metabolism & Toxicology
Thamer A Almangour, Valerie Fletcher, Mohammed Alessa, Abdullah A Alhifany, Deanne Tabb
BACKGROUND Native vertebral osteomyelitis (NVO) is a common form of hematogenous osteomyelitis, with Staphylococcus aureus (S. aureus) being the most commonly isolated organism. Dalbavancin is approved by the US Food and Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and has a sufficiently promising pharmacokinetic and pharmacodynamic profile to be considered for the treatment of vertebral osteomyelitis. We describe here what is probably the first reported case of using multiple weekly dalbavancin to treat a complicated methicillin-resistant Staphylococcus aureus (MRSA) bacteremia and vertebral osteomyelitis...
December 9, 2017: American Journal of Case Reports
Fabio Arena, Emilio Romanini, Elia Rosi, Carlo Salomone, Gabriele Tucci, Ciro Pempinello, Massimo Fantoni
Antimicrobial resistance is continuously increasing among bacterial clinical isolates (especially methicillin resistance in Staphylococcus aureus, MRSA), negatively impacting on outcomes of patients with Surgical Site Infections (SSIs). A multi-disciplinary team work is essential for SSIs prevention and for the choice of antibiotic therapy of orthopaedic SSIs. In particular, an Antibiotic Stewardship (AS) approach is recommended for preserving the activity of old and new antimicrobials. Dalbavancin is a novel antimicrobial agent, belonging to the lipoglycopeptides family, recently approved by FDA for the treatment of ABSSSIs (Acute Bacterial Skin and Skin Structure Infections) and can be considered as a candidate for the treatment of orthopaedic superficial SSIs...
November 23, 2017: Journal of Chemotherapy
Jolene K Berg, Evan Tzanis, Lynne Garrity-Ryan, Stephen Bai, Surya Chitra, Amy Manley, Stephen Villano
Many antibiotics require dosing adjustments in patients with renal impairment and/or in those undergoing hemodialysis. Omadacycline, the first aminomethylcycline antibiotic in late-stage clinical development, displays activity against a broad-spectrum of bacterial pathogens, including resistant strains. Data from completed phase 3 acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) studies showed intravenous (IV) to once-daily oral omadacycline to be clinically effective and well tolerated...
November 20, 2017: Antimicrobial Agents and Chemotherapy
Julian F Guest, Jaime Esteban, Anton G Manganelli, Andrea Novelli, Giuliano Rizzardini, Miquel Serra
OBJECTIVE: This NMA compared the efficacy and safety between IV antibiotics that are used in the current standard of care for managing adult patients (≥18 years of age) with ABSSSI. METHODS: Comparators were chosen on the basis that both direct and indirect comparisons between the interventions of interest could be performed. Outcomes of the analysis were selected on the basis that they are frequently measured and reported in trials involving ABSSSI patients, and only published randomised control trials of any size and duration and with any blinding status were eligible for inclusion in the analysis...
2017: PloS One
Thomas Lodise, John Bosso, Colleen Kelly, Paul J Williams, James R Lane, David B Huang
Iclaprim is a bacterial dihydrofolate reductase inhibitor that is currently being evaluated in two Phase 3 trials for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Prior animal infection models studies suggest that the pharmacokinetic and pharmacodynamics (PK/PD) drivers for efficacy are area under the curve from 0-24 hours at steady state (AUC0-24hss), AUC/minimum inhibitory concentration (MIC), and time above the MIC during the dosing interval (T > MIC) while QTc prolongation was associated to maximal concentration at steady state (Cmaxss) in a thorough QTc Phase 1 study...
November 13, 2017: Antimicrobial Agents and Chemotherapy
Jonathan C Cho, Matthew P Crotty, Bryan P White, Marylee V Worley
Delafloxacin is a new fluoroquinolone antimicrobial approved for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) in adults using dosage regimens of 300 mg intravenously every 12 hours, 450 mg orally every 12 hours, or switching from intravenous to oral regimens for a 5- to 14-day treatment duration. Dosage adjustments in patients with severe renal dysfunction (estimated glomerular filtration rate [eGFR] = 15-29 ml/min/1.73 m2 ) are not required for oral doses but should be decreased to 200 mg intravenously every 12 hours in patients requiring parenteral therapy...
January 2018: Pharmacotherapy
Jeffrey W Jansen, Ryan P Moenster
BACKGROUND: Ceftaroline is a broad-spectrum, methicillin-resistant Staphylococcus aureus (MRSA)-active β-lactam approved for acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired pneumonia. Because of its favorable spectrum and pharmacokinetics, ceftaroline is frequently utilized for infections such as osteomyelitis and endocarditis. Ceftaroline has been associated with neutropenia, but evaluation of other adverse events remains limited. OBJECTIVE: To describe the rates and types of ceftaroline-associated adverse events and determine if patients' baseline allergies affect the rates of an adverse event...
March 2018: Annals of Pharmacotherapy
Abraham Pulido-Cejudo, Mario Guzmán-Gutierrez, Abel Jalife-Montaño, Alejandro Ortiz-Covarrubias, Jose Luis Martínez-Ordaz, Héctor Faustino Noyola-Villalobos, Luis Mauricio Hurtado-López
Over the last 25 years, the terminology of skin and soft tissue infections, as well as their classification for optimal management of patients, has changed. The so-called and recently introduced term 'acute bacterial skin and skin structure infections' (ABSSSIs), a cluster of fairly common types of infection, including abscesses, cellulitis, and wound infections, require an immediate effective antibacterial treatment as part of a timely and cautious management. The extreme level of resistance globally to many antibiotic drugs in the prevalent causative pathogens, the presence of risk factors of treatment failure, and the high epidemic of comorbidities (e...
September 2017: Therapeutic Advances in Infectious Disease
Kimberly C Claeys, Evan J Zasowski, Abdalhamid M Lagnf, Donald P Levine, Susan L Davis, Michael J Rybak
Methicillin-resistant Staphylococcus aureus acute bacterial skin and skin structure infections (MRSA ABSSSIs) are associated with a significant clinical and economic burden; however, rapid identification of MRSA remains a clinical challenge. This study aimed to use a novel method of predictive modeling to determine those at highest risk of MRSA ABSSSIs. Risk factors for MRSA ABSSSI were derived from a combination of previously published literature and multivariable logistic regression of individual patient data (IPD) using the 'adaptation method...
January 2018: International Journal of Antimicrobial Agents
S McCurdy, L Lawrence, M Quintas, L Woosley, R Flamm, C Tseng, S Cammarata
Delafloxacin is an investigational anionic fluoroquinolone antibiotic with broad-spectrum in vitro activity, including activity against Gram-positive organisms, Gram-negative organisms, atypical organisms, and anaerobes. The in vitro activity of delafloxacin and the percent microbiological response in subjects infected with fluoroquinolone-susceptible and nonsusceptible Staphylococcus aureus isolates were determined from two global phase 3 studies of delafloxacin versus vancomycin plus aztreonam in patients with acute bacterial skin and skin structure infections (ABSSSI)...
September 2017: Antimicrobial Agents and Chemotherapy
Dino J Delaportas, Sandy J Estrada, Matthew Darmelio
Staphylococcus aureus remains the most common causative pathogen in osteomyelitis. New or alternative therapies are often needed to treat S. aureus infections adequately in patients with drug allergies, treatment failures, or drug interactions. Oritavancin is a novel long-acting lipoglycopeptide approved by the U.S. Food and Drug Administration in 2014 for the treatment of acute bacterial skin and skin structure infections. With a terminal half-life of 8-10 days, oritavancin dosing regimens with infrequent parenteral administration now exist to treat infectious diseases such as osteomyelitis that would otherwise require daily dosing of intravenous antimicrobials for weeks; however, clinical experience is lacking...
August 2017: Pharmacotherapy
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