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https://www.readbyqxmd.com/read/29281036/a-phase-3-randomized-double-blind-multicenter-study-to-evaluate-the-safety-and-efficacy-of-intravenous-iclaprim-vs-vancomycin-for-the-treatment-of-acute-bacterial-skin-and-skin-structure-infections-suspected-or-confirmed-to-be-due-to-gram-positive-pathogens
#1
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
https://www.readbyqxmd.com/read/29258361/pharmacokinetic-drug-evaluation-of-dalbavancin-for-the-treatment-of-skin-infections
#2
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
https://www.readbyqxmd.com/read/29222405/multiple-weekly-dalbavancin-dosing-for-the-treatment-of-native-vertebral-osteomyelitis-caused-by-methicillin-resistant-staphylococcus-aureus-a-case-report
#3
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
https://www.readbyqxmd.com/read/29168673/the-role-of-dalbavancin-in-the-multi-disciplinary-management-of-wound-infections-in-orthopaedic-surgery
#4
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
https://www.readbyqxmd.com/read/29158281/pharmacokinetics-and-safety-of-omadacycline-in-subjects-with-impaired-renal-function
#5
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
https://www.readbyqxmd.com/read/29136035/comparative-efficacy-and-safety-of-antibiotics-used-to-treat-acute-bacterial-skin-and-skin-structure-infections-results-of-a-network-meta-analysis
#6
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
https://www.readbyqxmd.com/read/29133566/use-of-pharmacokinetic-and-pharmacodynamic-analyses-to-determine-the-optimal-fixed-dosing-regimen-of-iclaprim-for-treatment-of-serious-gram-positive-infections
#7
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
https://www.readbyqxmd.com/read/29059465/what-is-old-is-new-again-delafloxacin-a-modern-fluoroquinolone
#8
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/1.73m(2) ) are not required for oral doses but should be decreased to 200 mg intravenously every 12 hours in patients requiring parenteral therapy...
October 23, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28980484/rate-and-incidence-of-adverse-reactions-associated-with-ceftaroline-exposure-importance-of-cutaneous-manifestations
#9
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...
October 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28959445/management-of-acute-bacterial-skin-and-skin-structure-infections-with-a-focus-on-patients-at-high-risk-of-treatment-failure
#10
REVIEW
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
https://www.readbyqxmd.com/read/28668679/novel-application-of-published-risk-factors-for-methicillin-resistant-s-aureus-in-acute-bacterial-skin-and-skin-structure-infections
#11
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...
June 28, 2017: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/28630189/in-vitro-activity-of-delafloxacin-and-microbiological-response-against-fluoroquinolone-susceptible-and-nonsusceptible-staphylococcus-aureus-isolates-from-two-phase-3-studies-of-acute-bacterial-skin-and-skin-structure-infections
#12
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
https://www.readbyqxmd.com/read/28543367/successful-treatment-of-methicillin-susceptible-staphylococcus-aureus-osteomyelitis-with-oritavancin
#13
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
https://www.readbyqxmd.com/read/28480266/efficacy-and-safety-of-oritavancin-relative-to-vancomycin-for-patients-with-acute-bacterial-skin-and-skin-structure-infections-absssi-in-the-outpatient-setting-results-from-the-solo-clinical-trials
#14
Thomas P Lodise, Mark Redell, Shannon O Armstrong, Katherine A Sulham, G Ralph Corey
BACKGROUND: The objective of this analysis was to evaluate the efficacy and safety of oritavancin compared with vancomycin for patients with acute bacterial skin and skin structure infections (ABSSSIs) who received treatment in the outpatient setting in the Phase 3 SOLO clinical trials. METHODS: SOLO I and SOLO II were 2 identically designed comparative, multicenter, double-blind, randomized studies to evaluate the efficacy and safety of a single 1200-mg dose of intravenous (IV) oritavancin versus 7-10 days of twice-daily IV vancomycin for the treatment of ABSSSI...
2017: Open Forum Infectious Diseases
https://www.readbyqxmd.com/read/28406838/managing-acute-bacterial-skin-and-skin-structure-infections-focus-on-new-lipoglycopeptides
#15
Allison M Bell, S Travis King, Katie E Barber, Kim G Adcock, Jamie L Wagner, Kayla R Stover
Acute bacterial skin and skin structure infections (ABSSSI) are some of the most commonly encountered infections worldwide. Hospitalizations as a result of ABSSSI are associated with high mortality. This article discusses the role of oritavancin and dalbavancin, two new lipoglycopeptides, in the context of the other I.V. available standard therapy options.
May 12, 2017: Nurse Practitioner
https://www.readbyqxmd.com/read/28373199/efficacy-safety-and-tolerability-of-gepotidacin-gsk2140944-in-the-treatment-of-patients-with-suspected-or-confirmed-gram-positive-acute-bacterial-skin-and-skin-structure-infections
#16
William O'Riordan, Courtney Tiffany, Nicole Scangarella-Oman, Caroline Perry, Mohammad Hossain, Teri Ashton, Etienne Dumont
Gepotidacin is a novel, first-in-class, triazaacenaphthylene antibacterial agent which has in vitro activity against causative pathogens of acute bacterial skin and skin structure infections (ABSSSIs). This phase 2, randomized, 2-part, multicenter, dose-ranging, response-adaptive study with optional intravenous-oral switch evaluated the efficacy and safety of gepotidacin for the treatment of Gram-positive ABSSSIs in 122 adult patients in the United States. The study had a double-blind phase (part 1; intravenous [750 mg or 1,000 mg every 12 h {q12h}]) and an open-label phase (part 2; intravenous [750 mg q12h, 1,000 mg q12h, or 1,000 q8h])...
June 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28264845/clinical-response-of-tedizolid-versus-linezolid-in-acute-bacterial-skin-and-skin-structure-infections-by-severity-measure-using-a-pooled-analysis-from-two-phase-3-double-blind-trials
#17
Taylor Sandison, Carisa De Anda, Edward Fang, Anita F Das, Philippe Prokocimer
Tedizolid phosphate is approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI). In a pooled analysis of 1,333 ABSSSI patients from the ESTABLISH clinical trials, treatment with tedizolid or linezolid demonstrated similar early and posttherapy clinical responses in nonsevere and severe disease, irrespective of the parameters used to measure ABSSSI severity. Shorter 6-day treatment of ABSSSI, including those that were severe, with tedizolid phosphate demonstrated efficacy comparable to that of 10-day treatment with linezolid...
May 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28179245/ceftaroline-for-the-treatment-of-methicillin-resistant-staphylococcus-aureus-bacteremia
#18
Bryan Pinckney White, Katie E Barber, Kayla R Stover
PURPOSE: The utility of ceftaroline for the treatment of methicillin-resistant Staphylococcus aureus bacteremia (MRSAB) is reviewed. SUMMARY: Ceftaroline was originally approved for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSIs) but recently received an additional approval for the treatment of S. aureus bacteremia (SAB) associated with ABSSSIs. Ceftaroline has demonstrated efficacy for the treatment of MRSAB, including isolates with elevated minimum inhibitory concentrations to conventional therapy when used alone or in combination with other agents...
February 15, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28140693/pharmacokinetic-drug-evaluation-of-tedizolid-for-the-treatment-of-skin-infections
#19
REVIEW
Darrell McBride, Tamara Krekel, Kevin Hsueh, Michael J Durkin
Tedizolid is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Although tedizolid shares many similar properties with linezolid, another oxazolidinone used to treat ABSSSI, the two antibiotics have several key differences. Areas covered: This review provides a detailed summary of the overall pharmacodynamics, pharmacokinetics, clinical efficacy, and safety of tedizolid for the treatment of ABSSSI. Expert opinion: Compared to other antibiotics used for ABSSSI, tedizolid has several advantages...
March 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28131729/ceftaroline-fosamil-monotherapy-for-methicillin-resistant-staphylococcus-aureus-bacteremia-a-comparative-clinical-outcomes-study
#20
COMPARATIVE STUDY
Samia Arshad, Vanthida Huang, Pamela Hartman, Mary B Perri, Daniela Moreno, Marcus J Zervos
OBJECTIVES: Vancomycin is the treatment of choice for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia; however, its use has been subject to scrutiny due to failure in severe infections. Ceftaroline fosamil (CPT-F) is approved for MRSA acute bacterial skin and skin structure infections, but not for bloodstream infections. The clinical outcomes of treatment with CPT-F in patients with MRSA bacteremia were evaluated. METHODS: Patients diagnosed with MRSA bacteremia at Henry Ford Hospital in Detroit, Michigan, USA, involving isolates with a vancomycin minimum inhibitory concentration ≥1...
April 2017: International Journal of Infectious Diseases: IJID
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