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https://www.readbyqxmd.com/read/29783024/a-pooled-analysis-of-the-phase-3-revive-trials-randomized-double-blind-studies-to-evaluate-the-safety-and-efficacy-of-iclaprim-versus-vancomycin-for-treatment-of-acute-bacterial-skin-and-skin-structure-infections
#1
David B Huang, G Ralph Corey, Thomas L Holland, Thomas Lodise, William O'Riordan, Mark H Wilcox, Thomas M File, Matthew Dryden, Barbara Balser, Eve Desplats, Antoni Torres
BACKGROUND: Iclaprim, a diaminopyrimidine antibiotic, was compared with vancomycin for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSIs) in two studies (REVIVE-1 and REVIVE-2). OBJECTIVES: We explored the efficacy and tolerability of iclaprim in a pooled analysis of results from both studies. METHODS: REVIVE-1 and REVIVE-2 were Phase 3, double-blind, randomized (1:1), multicenter, active-controlled, non-inferiority (margin of 10%) trials, each designed to enroll 600 patients a piece with ABSSSI...
May 18, 2018: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/29742926/iclaprim-a-dihydrofolate-reductase-inhibitor-antibiotic-in-phase-iii-of-clinical-development-a-review-of-its-pharmacology-microbiology-and-clinical-efficacy-and-safety
#2
David B Huang, Matthew Dryden
Iclaprim is under clinical development for treating acute bacterial skin and skin structure infections (ABSSSI) and nosocomial pneumonia most often due to Gram-positive bacteria, including infections due to drug-resistant bacteria. In two recent Phase III studies of patients with acute bacterial skin and skin structure infections, intravenous iclaprim 80 mg every 12 h was noninferior to dose-adjusted vancomycin. Additional studies are planned for patients with nosocomial pneumonia. Iclaprim represents an alternative for the treatment of severe skin and pulmonary infections due to Gram-positive bacteria...
May 10, 2018: Future Microbiology
https://www.readbyqxmd.com/read/29721574/lack-of-phototoxicity-potential-with-delafloxacin-in-healthy-male-and-female-subjects-comparison-to-lomefloxacin
#3
R S Dawe, J Ferguson, S Ibbotson, L Lawrence, S Paulson, E Duffy, S Cammarata
AIMS: Delafloxacin is a fluoroquinolone antibiotic recently approved by the FDA for treatment of acute bacterial skin and skin structure infections (ABSSSI). Delafloxacin was assessed for phototoxicity potential compared with a known phototoxic fluoroquinolone. METHODS: A Phase 1, investigator-blind, placebo/active-controlled, randomized, parallel-group study was conducted in 52 healthy male and female volunteers who received 200 or 400 mg of oral delafloxacin, 400 mg oral lomefloxacin or placebo once daily for 6 days...
May 3, 2018: Photochemical & Photobiological Sciences
https://www.readbyqxmd.com/read/29670380/emerging-treatment-options-for-acute-bacterial-skin-and-skin-structure-infections-focus-on-intravenous-delafloxacin
#4
REVIEW
Elda Righi, Alessia Carnelutti, Antonio Vena, Matteo Bassetti
The increase in hospitalization due to acute bacterial skin and skin structure infections (ABSSSI) caused by resistant pathogens supports the need for new treatment options. Antimicrobial options for ABSSSI that provide broad-spectrum coverage, including gram-negative pathogens and multidrug-resistant gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), are limited. Delafloxacin is a novel fluoroquinolone available as intravenous and oral formulations and is characterized by an increased efficacy in acidic environments and activity on bacterial biofilm...
2018: Infection and Drug Resistance
https://www.readbyqxmd.com/read/29530858/a-phase-3-randomized-double-blind-multicenter-study-to-evaluate-the-safety-and-efficacy-of-intravenous-iclaprim-versus-vancomycin-for-treatment-of-acute-bacterial-skin-and-skin-structure-infections-suspected-or-confirmed-to-be-due-to-gram-positive-pathogens
#5
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 (ABSSSIs) suspected or confirmed to be due to Gram-positive pathogens were randomized to iclaprim (80 mg) or vancomycin (15 mg/kg of body weight), both of which were administered intravenously every 12 h for 5 to 14 days...
May 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29518178/a-comparison-of-the-efficacy-and-safety-of-intravenous-followed-by-oral-delafloxacin-with-vancomycin-plus-aztreonam-for-the-treatment-of-acute-bacterial-skin-and-skin-structure-infections-a-phase-3-multinational-double-blind-randomized-study
#6
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
https://www.readbyqxmd.com/read/29509504/a-cost-minimization-analysis-of-dalbavancin-compared-to-conventional-therapy-for-the-outpatient-treatment-of-acute-bacterial-skin-and-skin-structure-infections
#7
COMPARATIVE STUDY
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
https://www.readbyqxmd.com/read/29425340/clinical-review-of-delafloxacin-a-novel-anionic-fluoroquinolone
#8
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
https://www.readbyqxmd.com/read/29384903/outpatient-treatment-of-acute-bacterial-skin-and-skin-structure-infections-absssi-with-tedizolid-phosphate-and-linezolid-in-patients-in-the-united-states-subgroup-analysis-of-2-randomized-phase-3-trials
#9
RANDOMIZED CONTROLLED TRIAL
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)
https://www.readbyqxmd.com/read/29358292/single-intravenous-dose-of-oritavancin-for-treatment-of-acute-skin-and-skin-structure-infections-caused-by-gram-positive-bacteria-summary-of-safety-analysis-from-the-phase-3-solo-studies
#10
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 single-dose treatment of acute bacterial skin and skin structure infections (ABSSSI). SOLO I and SOLO II were randomized, double-blind studies evaluating the efficacy and safety of a single 1,200-mg intravenous (i.v.) dose of oritavancin versus twice-daily i.v. vancomycin for 7 to 10 days in ABSSSI patients. Safety data from both studies were pooled for safety analysis...
April 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29356694/the-optimal-duration-of-treatment-for-skin-and-soft-tissue-infections-and-acute-bacterial-skin-and-skin-structure-infections
#11
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
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
#12
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
#13
REVIEW
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...
February 2018: 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
#14
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
#15
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
#16
Jolene K Berg, Evan Tzanis, Lynne Garrity-Ryan, Stephen Bai, Surya Chitra, Amy Manley, Stephen Villano
Many antibiotics require dose 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 drug-resistant strains. Data from completed phase 3 studies of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) showed intravenous (i...
February 2018: 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
#17
COMPARATIVE STUDY
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/pharmacokinetic-and-pharmacodynamic-analyses-to-determine-the-optimal-fixed-dosing-regimen-of-iclaprim-for-treatment-of-patients-with-serious-infections-caused-by-gram-positive-pathogens
#18
Thomas P 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 model studies suggest that the pharmacokinetic/pharmacodynamic (PK/PD) drivers for efficacy are area under the concentration-time curve from 0 to 24 h at steady state (AUC0-24ss ), AUC/MIC, and time above the MIC during the dosing interval ( T > MIC), while QTc prolongation was associated with the maximal concentration at steady state ( C maxss ) in a thorough QTc phase 1 study...
February 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29059465/what-is-old-is-new-again-delafloxacin-a-modern-fluoroquinolone
#19
REVIEW
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
https://www.readbyqxmd.com/read/28980484/rate-and-incidence-of-adverse-reactions-associated-with-ceftaroline-exposure-importance-of-cutaneous-manifestations
#20
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
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