Ceftaroline for Suspected Or Confirmed Invasive Methicillin-Resistant Staphylococcus Aureus: a Pharmacokinetic Case Series
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Medical Review(S) Clinical Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 200327 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 200327 Priority or Standard Standard Submit Date(s) December 29, 2009 Received Date(s) December 30, 2009 PDUFA Goal Date October 30, 2010 Division / Office Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products Reviewer Name(s) Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD Review Completion October 29, 2010 Date Established Name Ceftaroline fosamil for injection (Proposed) Trade Name Teflaro Therapeutic Class Cephalosporin; ß-lactams Applicant Cerexa, Inc. Forest Laboratories, Inc. Formulation(s) 400 mg/vial and 600 mg/vial Intravenous Dosing Regimen 600 mg every 12 hours by IV infusion Indication(s) Acute Bacterial Skin and Skin Structure Infection (ABSSSI); Community-acquired Bacterial Pneumonia (CABP) Intended Population(s) Adults ≥ 18 years of age Template Version: March 6, 2009 Reference ID: 2857265 Clinical Review Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD NDA 200327: Teflaro (ceftaroline fosamil) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ......................................... 9 1.1 Recommendation on Regulatory Action ........................................................... 10 1.2 Risk Benefit Assessment.................................................................................. 10 1.3 Recommendations for Postmarketing Risk Evaluation and Mitigation Strategies ........................................................................................................................ -
Use of Ceftaroline Fosamil in Children: Review of Current Knowledge and Its Application
Infect Dis Ther (2017) 6:57–67 DOI 10.1007/s40121-016-0144-8 REVIEW Use of Ceftaroline Fosamil in Children: Review of Current Knowledge and its Application Juwon Yim . Leah M. Molloy . Jason G. Newland Received: November 10, 2016 / Published online: December 30, 2016 Ó The Author(s) 2016. This article is published with open access at Springerlink.com ABSTRACT infections, CABP caused by penicillin- and ceftriaxone-resistant S. pneumoniae and Ceftaroline is a novel cephalosporin recently resistant Gram-positive infections that fail approved in children for treatment of acute first-line antimicrobial agents. However, bacterial skin and soft tissue infections and limited data are available on tolerability in community-acquired bacterial pneumonia neonates and infants younger than 2 months (CABP) caused by methicillin-resistant of age, and on pharmacokinetic characteristics Staphylococcus aureus, Streptococcus pneumoniae in children with chronic medical conditions and other susceptible bacteria. With a favorable and those with invasive, complicated tolerability profile and efficacy proven in infections. In this review, the microbiological pediatric patients and excellent in vitro profile of ceftaroline, its mechanism of action, activity against resistant Gram-positive and and pharmacokinetic profile will be presented. Gram-negative bacteria, ceftaroline may serve Additionally, clinical evidence for use in as a therapeutic option for polymicrobial pediatric patients and proposed place in therapy is discussed. Enhanced content To view enhanced content for this article go to http://www.medengine.com/Redeem/ 1F47F0601BB3F2DD. Keywords: Antibiotic resistance; Ceftaroline J. Yim (&) fosamil; Children; Methicillin-resistant St. John Hospital and Medical Center, Detroit, MI, Staphylococcus aureus; Streptococcus pneumoniae USA e-mail: [email protected] L. -
Severe Sepsis and Septic Shock Antibiotic Guide
Stanford Health Issue Date: 05/2017 Stanford Antimicrobial Safety and Sustainability Program Severe Sepsis and Septic Shock Antibiotic Guide Table 1: Antibiotic selection options for healthcare associated and/or immunocompromised patients • Healthcare associated: intravenous therapy, wound care, or intravenous chemotherapy within the prior 30 days, residence in a nursing home or other long-term care facility, hospitalization in an acute care hospital for two or more days within the prior 90 days, attendance at a hospital or hemodialysis clinic within the prior 30 days • Immunocompromised: Receiving chemotherapy, known systemic cancer not in remission, ANC <500, severe cell-mediated immune deficiency Table 2: Antibiotic selection options for community acquired, immunocompetent patients Table 3: Antibiotic selection options for patients with simple sepsis, community acquired, immunocompetent patients requiring hospitalization. Risk Factors for Select Organisms P. aeruginosa MRSA Invasive Candidiasis VRE (and other resistant GNR) Community acquired: • Known colonization with MDROs • Central venous catheter • Liver transplant • Prior IV antibiotics within 90 day • Recent MRSA infection • Broad-spectrum antibiotics • Known colonization • Known colonization with MDROs • Known MRSA colonization • + 1 of the following risk factors: • Prolonged broad antibacterial • Skin & Skin Structure and/or IV access site: ♦ Parenteral nutrition therapy Hospital acquired: ♦ Purulence ♦ Dialysis • Prolonged profound • Prior IV antibiotics within 90 days ♦ Abscess -
Below Are the CLSI Breakpoints for Selected Bacteria. Please Use Your Clinical Judgement When Assessing Breakpoints
Below are the CLSI breakpoints for selected bacteria. Please use your clinical judgement when assessing breakpoints. The lowest number does NOT equal most potent antimicrobial. Contact Antimicrobial Stewardship for drug selection and dosing questions. Table 1: 2014 MIC Interpretive Standards for Enterobacteriaceae (includes E.coli, Klebsiella, Enterobacter, Citrobacter, Serratia and Proteus spp) Antimicrobial Agent MIC Interpretive Criteria (g/mL) Enterobacteriaceae S I R Ampicillin ≤ 8 16 ≥ 32 Ampicillin-sulbactam ≤ 8/4 16/8 ≥ 32/16 Aztreonam ≤ 4 8 ≥ 16 Cefazolin (blood) ≤ 2 4 ≥ 8 Cefazolin** (uncomplicated UTI only) ≤ 16 ≥ 32 Cefepime* ≤ 2 4-8* ≥ 16 Cefotetan ≤ 16 32 ≥ 64 Ceftaroline ≤ 0.5 1 ≥ 2 Ceftazidime ≤ 4 8 ≥ 16 Ceftriaxone ≤ 1 2 ≥ 4 Cefpodoxime ≤ 2 4 ≥ 8 Ciprofloxacin ≤ 1 2 ≥ 4 Ertapenem ≤ 0.5 1 ≥ 2 Fosfomycin ≤ 64 128 ≥256 Gentamicin ≤ 4 8 ≥ 16 Imipenem ≤ 1 2 ≥ 4 Levofloxacin ≤ 2 4 ≥ 8 Meropenem ≤ 1 2 ≥ 4 Piperacillin-tazobactam ≤ 16/4 32/4 – 64/4 ≥ 128/4 Trimethoprim-sulfamethoxazole ≤ 2/38 --- ≥ 4/76 *Susceptibile dose-dependent – see chart below **Cefazolin can predict results for cefaclor, cefdinir, cefpodoxime, cefprozil, cefuroxime axetil, cephalexin and loracarbef for uncomplicated UTIs due to E.coli, K.pneumoniae, and P.mirabilis. Cefpodoxime, cefinidir, and cefuroxime axetil may be tested individually because some isolated may be susceptible to these agents while testing resistant to cefazolin. Cefepime dosing for Enterobacteriaceae ( E.coli, Klebsiella, Enterobacter, Citrobacter, Serratia & Proteus spp) Susceptible Susceptible –dose-dependent (SDD) Resistant MIC </= 2 4 8 >/= 16 Based on dose of: 1g q12h 1g every 8h or 2g every 8 h Do not give 2g q12 Total dose 2g 3-4g 6g NA Table 2: 2014 MIC Interpretive Standards for Pseudomonas aeruginosa and Acinetobacter spp. -
Piperacillin/Tazobactam Drug Class1 Antibiotic – Penicillin with Β-Lactamase Inhibitor
Monographs for Commonly Administered Intravenous Medications in Home and Community Care Piperacillin/Tazobactam Drug Class1 Antibiotic – penicillin with β-lactamase inhibitor Spectrum1 Refer to product monograph for complete spectrum For β-lactamase producing bacteria strains (e.g., Haemophilus influenza, Escherichia coli, and Staphylococcus aureus). Also to susceptible Acinetobacter species, Klebsiella pneumonia, Pseudomonas aeruginosa often combined with aminoglycoside). Cross Sensitivities / Allergies1 Cross sensitivities with penicillin and possibly cephalosporin and/or beta-lactam inhibitors Indications1,2 Intra-abdominal Respiratory tract Skin and skin structure Septicemia Gynecological Urinary tract Other conditions based on culture and sensitivity results Outpatient Considerations1 For patients with a documented allergy to penicillin, cephalosporin or beta-lactam inhibitor, the first dose should be administered in a hospital or clinic setting. Must be able to access laboratory monitoring (either at outpatient laboratory or by arranging in-home lab) if using an interacting oral medication (see Potential Drug Interactions section) Prescribing Considerations At time of ordering please provide the following to the pharmacist: and Dosage in Adults1,2 Height, weight Most recent serum creatinine with date obtained Indication (infection being treated) Usually dosed every 6 to 8 hours. Available as 2 g/0.25 g, 3 g/0.375 g, 4 g/0.5 g piperacillin/tazobactam (dose selected based on indication) Maximum 18 g/ 2.25 g piperacillin/tazobactam daily Dose and administration interval require adjustment for renal impairment Errors have occurred due to unusual ordering as combined dose of piperacillin and tazobactam. Order may be expressed only as piperacillin component or as a total of piperacillin + tazobactam (8:1 ratio). -
Safety and Efficacy of Ceftaroline Fosamil in the Management of Community-Acquired Bacterial Pneumonia Heather F
Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Scholarly Papers 2014 Safety and Efficacy of Ceftaroline Fosamil in the Management of Community-Acquired Bacterial Pneumonia Heather F. DeBellis Kimberly L. Barefield Philadelphia College of Osteopathic Medicine, [email protected] Follow this and additional works at: https://digitalcommons.pcom.edu/scholarly_papers Part of the Medicine and Health Sciences Commons Recommended Citation DeBellis, Heather F. and Barefield, Kimberly L., "Safety and Efficacy of Ceftaroline Fosamil in the Management of Community- Acquired Bacterial Pneumonia" (2014). PCOM Scholarly Papers. 1913. https://digitalcommons.pcom.edu/scholarly_papers/1913 This Article is brought to you for free and open access by DigitalCommons@PCOM. It has been accepted for inclusion in PCOM Scholarly Papers by an authorized administrator of DigitalCommons@PCOM. For more information, please contact [email protected]. Open Access: Full open access to Clinical Medicine Reviews this and thousands of other papers at http://www.la-press.com. in Therapeutics Safety and Efficacy of Ceftaroline Fosamil in the Management of Community- Acquired Bacterial Pneumonia Heather F. DeBellis and Kimberly L. Tackett South University School of Pharmacy, Savannah, GA, USA. ABSTR ACT: Ceftaroline fosamil is a new fifth-generation cephalosporin indicated for the treatment of community-acquired bacterial pneumonia (CABP). It possesses antimicrobial effects against both Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), but not against anaerobes. Organisms covered by this novel agent that are commonly associated with CABP are Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Moraxella catarrhalis, and Klebsiella pneumoniae; however, ceftaroline fosamil lacks antimicrobial activity against Pseudomonas and Acinetobacter species. -
Ceftaroline in Complicated Skin and Skin-Structure Infections
Infection and Drug Resistance Dovepress open access to scientific and medical research Open Access Full Text Article REVIEW Ceftaroline in complicated skin and skin-structure infections Paul O Hernandez1 Abstract: Ceftaroline is an advanced-generation cephalosporin antibiotic recently approved by Sergio Lema2 the US Food and Drug Administration for the treatment of complicated skin and skin-structure Stephen K Tyring3 infections (cSSSIs). This intravenous broad-spectrum antibiotic exerts potent bactericidal activity Natalia Mendoza2,4 by inhibiting bacterial cell wall synthesis. A high affinity for the penicillin-binding protein 2a (PBP2a) of methicillin-resistant Staphylococcus aureus (MRSA) makes the drug especially 1University of Texas School of Medicine at San Antonio, beneficial to patients with MRSA cSSSIs. Ceftaroline has proved in multiple well-conducted San Antonio, TX, 2Woodhull clinical trials to have an excellent safety and efficacy profile. In adjusted doses it is also recom- Medical and Mental Health Center, mended for patients with renal or hepatic impairment. Furthermore, the clinical effectiveness Brooklyn, NY, 3Department of Dermatology, University of Texas and high cure rate demonstrated by ceftaroline in cSSSIs, including those caused by MRSA Health Science Center at Houston, and other multidrug-resistant strains, warrants its consideration as a first-line treatment option 4 Houston, TX, USA; Department of for cSSSIs. This article reviews ceftaroline and its pharmacology, efficacy, and safety data to Dermatology, El -
Journal Club: “Effect of Piperacillin-Tazobactam Vs
Infectious Disease Update 02/25/19 Steven T. Park Division of Infectious Diseases Objectives • Zosyn versus Meropenem for ESBL bacteremia • 7 versus 14 days for gram negative bacteremia • Oral versus IV for osteomyelitis “Effect of Piperacillin-Tazobactam vs Meropenem on 30-Day Mortality for Patients With E coli or Klebsiella pneumoniae Bloodstream Infection and Ceftriaxone Resistance” (MERINO trial) Harris PNA et al. JAMA 2018. Sep 11; 320:984. Introduction • Treatment of choice for ESBL organisms are thought to be carbapenems • Reports of failure of non-carbapenems in the past even when microbiologic data showed susceptibility • Most reported before CLSI lowered the breakpoints for Enterobacteriaceae • Recent reviews looking at retrospective data conclude that you can use non-carbapenems (Zosyn, Cefepime) for urine infections • However no randomized controlled trial testing this hypothesis • First randomized controlled trial testing whether Zosyn is equivalent to meropenem for ESBL bacteremia Design, Setting, Participants • Non-inferiority, parallel group, randomized clinical trial • Hospitalized patients enrolled from 26 sites in 9 countries (mostly from Singapore, Australia, Italy, Saudi Arabia, and Turkey) from February 2014 to July 2017 • Patients over the age of 21 was eligible if he/she had at least 1 positive blood culture with E coli or Klebsiella spp that was non-susceptible to ceftriaxone but susceptible to pip-tazo and meropenem • Of 1646 patients screened, 391 were included in the study. • Meropenem 1g IV q8h (n = 191) or piperacillin/tazobactam 4.5g IV q6h (not extended infusion, n = 188) was given for a minimum of 4 days and up to 14 days. The duration of therapy was determined by the treating clinician. -
Antimicrobials As Single and Combination Therapy for Colistin-Resistant Pseudomonas Aeruginosa at a University Hospital in Thailand
antibiotics Article Antimicrobials as Single and Combination Therapy for Colistin-Resistant Pseudomonas aeruginosa at a University Hospital in Thailand Supanun Pungcharoenkijkul 1,2, Jantima Traipattanakul 3, Sudaluck Thunyaharn 4 and Wichai Santimaleeworagun 5,6,* 1 College of Pharmacotherapy Thailand, Nontaburi 11000, Thailand; [email protected] 2 Department of Pharmacist, Nopparat Rajathanee Hospital, Bangkok 10230, Thailand 3 Division of Infectious Disease, Department of Medicine, Phramongkutklao Hospital, Bangkok 10400, Thailand; [email protected] 4 Faculty of Medical Technology, Nakhonratchasima College, Nakhon Ratchasima 30000, Thailand; [email protected] 5 Department of Pharmacy, Faculty of Pharmacy, Silpakorn University, Nakorn Pathom 73000, Thailand 6 Pharmaceutical Initiative for Resistant Bacteria and Infectious Disease Working Group (PIRBIG), Nakorn Pathom 73000, Thailand * Correspondence: [email protected]; Tel.: +66-3425-580-0 Received: 29 June 2020; Accepted: 31 July 2020; Published: 3 August 2020 Abstract: Global infections with colistin-resistant Pseudomonas aeruginosa (CoR-PA) are increasing; there are currently very few studies focused on the antimicrobial susceptibility of CoR-PA isolates, and none from Thailand. Here, we investigated the impact of various antimicrobials, alone and in combination, via the in vitro testing of CoR-PA clinical isolates. Eighteen CoR-PA isolates were obtained from patients treated at Phramongkutklao Hospital from January 2010 through June 2019; these were classified into six different clonal types by using the enterobacterial repetitive intergenic consensus (ERIC)-PCR method, with a high prevalence of Group A (27.8%). The antimicrobial susceptibility was determined as the minimal inhibitory concentrations (MICs) using the epsilometer-test (E-test) method. The synergistic activities of six antimicrobial combinations were reported via the fractional-inhibitory-concentration index. -
Vancomycin Plus Piperacillin/Tazobactam and Acute Kidney Injury in Adults: a Systematic Review and Meta-Analysis
University of Rhode Island DigitalCommons@URI Pharmacy Practice Faculty Publications Pharmacy Practice 2017 Vancomycin plus piperacillin/tazobactam and acute kidney injury in adults: a systematic review and meta-analysis Megan Luther Tristan Timbrook Aisling R. Caffrey University of Rhode Island, [email protected] David Dosa Thomas Lodise FSeeollow next this page and for additional additional works authors at: https:/ /digitalcommons.uri.edu/php_facpubs The University of Rhode Island Faculty have made this article openly available. Please let us know how Open Access to this research benefits you. This is a pre-publication author manuscript of the final, published article. Terms of Use This article is made available under the terms and conditions applicable towards Open Access Policy Articles, as set forth in our Terms of Use. Citation/Publisher Attribution Luther MK, Timbrook TT, Caffrey AR, Dosa D, Lodise TP, LaPlante KL. Vancomycin plus piperacillin/ tazobactam and acute kidney injury in adults: a systematic review and meta-analysis. Critical Care Medicine 2018; 46(1):12-20. doi: 10.1097/CCM.0000000000002769 Available at: http://dx.doi.org/10.1097/CCM.0000000000002769 This Article is brought to you for free and open access by the Pharmacy Practice at DigitalCommons@URI. It has been accepted for inclusion in Pharmacy Practice Faculty Publications by an authorized administrator of DigitalCommons@URI. For more information, please contact [email protected]. Authors Megan Luther, Tristan Timbrook, Aisling R. Caffrey, David Dosa, Thomas Lodise, and Kerry L. LaPlante This article is available at DigitalCommons@URI: https://digitalcommons.uri.edu/php_facpubs/142 1 Vancomycin plus piperacillin-tazobactam and acute kidney injury in adults: A systematic review 2 and meta-analysis 3 4 Date: August 19, 2017 5 6 Megan K. -
Ceftaroline Fosamil for the Treatment of Gram-Positive Endocarditis: CAPTURE Study Experience
International Journal of Antimicrobial Agents 53 (2019) 644–649 Contents lists available at ScienceDirect International Journal of Antimicrobial Agents journal homepage: www.elsevier.com/locate/ijantimicag Ceftaroline fosamil for the treatment of Gram-positive endocarditis: CAPTURE study experience ∗ Christopher J. Destache a, David J. Guervil b, Keith S. Kaye c, a School of Pharmacy and Health Professions, Creighton University, Omaha, NE, USA b Memorial Hermann-Texas Medical Center, Houston, TX, USA c Wayne State University and Detroit Medical Center, Detroit, MI, USA a r t i c l e i n f o a b s t r a c t Article history: Background: The clinical experience of ceftaroline fosamil (CPT-F) therapy for Gram-positive infective Received 3 October 2018 endocarditis is reported from CAPTURE, a retrospective study conducted in the USA. Accepted 27 January 2019 Methods: Data, including patient demographics, medical history, risk factors, microbiological aetiology and clinical outcomes, were collected by review of patient charts between September 2013 and February Editor: Professor Matthew Falagas 2015. Results: Patients ( n = 55) with Gram-positive endocarditis were treated with CPT-F. The most common Keywords: risk factors were intravascular devices (43.6%), diabetes mellitus (40.0%) and injection drug use (38.2%). Ceftaroline fosamil Gram-positive endocarditis The most commonly isolated pathogens were meticillin-resistant Staphylococcus aureus (MRSA; 80%), Meticillin-resistant Staphylococcus aureus meticillin-susceptible S. aureus (MSSA; 7.3%) and coagulase-negative staphylococci (7.3%). CPT-F was given Meticillin-susceptible Staphylococcus aureus as first-line therapy in 7.3% of patients and as second-line or later therapy in 92.7% of patients, and as CAPTURE study monotherapy in 41.8% of patients and as concurrent therapy in 58.2% of patients. -
Piperacillin and Tazobactam for Injection)
ZOSYN (Piperacillin and Tazobactam for Injection) only To reduce the development of drug-resistant bacteria and maintain the effectiveness of Zosyn (piperacillin and tazobactam) injection and other antibacterial drugs, Zosyn (piperacillin and tazobactam) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Zosyn (piperacillin and tazobactam for injection) is an injectable antibacterial combination product consisting of the semisynthetic antibiotic piperacillin sodium and the β-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine- carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is: Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is: 1 Zosyn, piperacillin/tazobactam parenteral combination, is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The formulation also contains edetate disodium dihydrate (EDTA) and sodium citrate. Each Zosyn 2.25 g single dose vial or ADD-Vantage vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam.