Pharmacy Practice

Publications

Bonine NG, Berger A, Altincatal A, Wang R, Bhagnani T, Gillard P, Lodise T. Impact of Delayed Appropriate Antibiotic Therapy on Patient Outcomes by Antibiotic Resistance Status From Serious Gram-negative Bacterial Infections. The American Journal of the Medical Sciences 2019 Feb;357(2):103-110. doi: 10.1016/j.amjms.2018.11.009. Epub 2018 Nov 22. PubMed PMID: 30665490.

Tartof SY, Kuntz JL, Chen LH, Wei R, Puzniak L, Tian Y, Im TM, Takhar HS, Merchant S, Lodise T. Development and Assessment of Risk Scores for Carbapenem and Extensive β-Lactam Resistance Among Adult Hospitalized Patients With Pseudomonas aeruginosa Infection. JAMA Network Open 2018 Oct 5;1(6):e183927. doi: 10.1001/jamanetworkopen.2018.3927. PubMed PMID: 30646267; PubMed Central PMCID: PMC6324445.

Hardalo C, Lodise TP, De Anda C. Myelosuppression with Oxazolidinones: Are There Differences? Antimicrobial Agents and Chemotherapy 2018 Dec 21;63(1). pii: e01833-18. doi: 10.1128/AAC.01833-18. Print 2019 Jan. PubMed PMID: 30578404.

Rank EL, Lodise T, Avery L, Bankert E, Dobson E, Dumyati G, Hassett S, Keller M, Pearsall M, Lubowski T, Carreno JJ. Antimicrobial Susceptibility Trends Observed in Urinary Pathogens Obtained From New York State. Open Forum Infectious Diseases 2018 Nov 16;5(11):ofy297. doi: 10.1093/ofid/ofy297. eCollection 2018 Nov. PubMed PMID: 30539040; PubMed Central PMCID: PMC6284462.

Lodise TP, Zhao Q, Fahrbach K, Gillard PJ, Martin A. A systematic review of the association between delayed appropriate therapy and mortality among patients hospitalized with infections due to Klebsiella pneumoniae or Escherichia coli: how long is too long? BMC Infect Diseases 2018 Dec 5;18(1):625. doi: 10.1186/s12879-018-3524-8. PubMed PMID: 30518337; PubMed Central PMCID: PMC6280436.

Bland CM, Pai MP, Lodise TP. Reappraisal of Contemporary Pharmacokinetic and Pharmacodynamic Principles for Informing Aminoglycoside Dosing. Pharmacotherapy. 2018 Dec;38(12):1229-1238. doi: 10.1002/phar.2193. PubMed PMID: 30403305.

Lodise T, Corey R, Hooper D, Cammarata S. Safety of Delafloxacin: Focus on Adverse Events of Special Interest. Open Forum Infectious Diseases. 2018 Sep 10;5(10):ofy220. doi: 10.1093/ofid/ofy220. eCollection 2018 Oct. PubMed PMID: 30349845; PubMed Central PMCID: PMC6189306.

Bidell MR, Lodise TP. Suboptimal Clinical Response Rates with Newer Antibiotics Among Patients with Moderate Renal Impairment: Review of the Literature and Potential Pharmacokinetic and Pharmacodynamic Considerations for Observed Findings. Pharmacotherapy. 2018 Dec;38(12):1205-1215. doi: 10.1002/phar.2184. Epub 2018 Nov 9. PubMed PMID: 30289995.

Crass RL, Pai MP, Lodise TP Jr. Individualizing piperacillin/tazobactam dosing in adult patients with cystic fibrosis: can tobramycin measurements help? Journal of Antimicrobial Chemotherapy 2019 Jan 1;74(1):126-129. doi: 10.1093/jac/dky388. PubMed PMID: 30252050.

Patel N, Huang D, Lodise T. Potential for Cost Saving with Iclaprim Owing to Avoidance of Vancomycin-Associated Acute Kidney Injury in Hospitalized Patients with Acute Bacterial Skin and Skin Structure Infections. Clinical Drug Investigation 2018 Oct;38(10):935-943. doi: 10.1007/s40261-018-0686-5. PubMed PMID: 30105549.

Martin A, Fahrbach K, Zhao Q, Lodise T. Association Between Carbapenem Resistance and Mortality Among Adult, Hospitalized Patients With Serious Infections Due to Enterobacteriaceae: Results of a Systematic Literature Review and Meta-analysis. Open Forum Infectious Diseases 2018 Jun 28;5(7):ofy150. doi: 10.1093/ofid/ofy150. eCollection 2018 Jul. Review. PubMed PMID: 30046639; PubMed Central PMCID: PMC6054228. 

Zasowski EJ, Lodise TP. The Importance of Individualized Vancomycin Dosing to Ensure Optimal Exposure Early in Therapy. The Journal of Clinical Pharmacology 2018 Sep;58(9):1131-1133. doi: 10.1002/jcph.1281. Epub 2018 Jul 19. PubMed PMID: 30024648.

Butterfield-Cowper JM, Lodise TP Jr, Pai MP. A Fixed versus Weight-Based Dosing Strategy of Daptomycin May Improve Safety in Obese Adults. Pharmacotherapy 2018 Sep;38(9):981-985. doi: 10.1002/phar.2157. Epub 2018 July 12. PubMed PMID: 29906315.

Huang DB, Corey GR, Holland TL, Lodise T, O'Riordan W, Wilcox MH, File TM Jr, Dryden M, Balser B, Desplats E, Torres A. Pooled analysis of the phase 3 REVIVE trials: randomised, double-blind studies to evaluate the safety and efficacy of iclaprim versus vancomycin for treatment of acute bacterial skin and skin-structure infections. International Journal of Antimicrobial Agents 2018 Aug;52(2):233-240. doi: 10.1016/j.ijantimicag.2018.05.012. Epub 2018 May 19. PubMed PMID: 29783024.

Holland TL, O'Riordan W, McManus A, Shin E, Borghei A, File TM Jr, Wilcox MH, Torres A, Dryden M, Lodise T, Oguri T, Corey GR, McLeroth P, Shukla R, Huang DB. 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 (REVIVE-2 Study). Antimicrobial Agents and Chemotherapy 2018 Apr 26;62(5). pii: e02580-17. doi: 10.1128/AAC.02580-17. Print 2018 May. PubMed PMID: 29530858; PubMed Central PMCID: PMC5923167.

Hardalo C, Lodise TP, Bidell M, Flanagan S, De Anda C, Anuskiewicz S, Prokocimer P. Clinical safety and tolerability of tedizolid phosphate in the treatment of acute bacterial skin and skin structure infections. Expert Opinion on Drug Safety 2018 Apr;17(4):359-367. doi: 10.1080/14740338.2018.1446939. Epub 2018 Mar 12. Review. PubMed PMID: 29528251.

McKinnell JA, Corman S, Patel D, Leung GH, Gordon LM, Lodise TP. Effective Antimicrobial Stewardship Strategies for Cost-effective Utilization of Telavancin for the Treatment of Patients With Hospital-acquired Bacterial Pneumonia Caused by Staphylococcus aureus. Clinical Therapeutics 2018 Mar;40(3):406-414.e2. doi: 10.1016/j.clinthera.2018.01.010. Epub 2018 Feb 15. PubMed PMID: 29454592.

Lodise TP, Bosso J, Kelly C, Williams PJ, Lane JR, Huang DB. 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. Antimicrobial Agents and Chemotherapy 2018 Jan 25;62(2). pii: e01184-17. doi: 10.1128/AAC.01184-17. Print 2018 Feb. PubMed PMID: 29133566; PubMed Central PMCID: PMC5786772.

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 Jan;46(1):12-20. doi: 10.1097/CCM.0000000000002769. Review. PubMed PMID: 29088001.

Lodise TP, Bidell M. Time to Evolve: Addressing the Challenge of CRE. Medscape https://www.medscape.org/viewarticle/894178.

Quantitative evaluation of antibiotic exposure-response relationships among hospital patients with serious bacterial infections.

My work has focused on quantitatively enhancing our current understanding of antimicrobial exposure-response relationships among hospitalized patients with invasive bacterial infections. The goal of these studies is to identify the antibiotic exposure profile associated with maximal outcomes/minimal toxicity among patients with infections.

• Lodise TP, Drusano GL, Zasowski E, Dihmess A, Lazariu V, Cosler L, McNutt LA. Vancomycin exposure in patients with MRSA bloodstream Infections: how much is enough? Clinical Infectious Diseases. 2014 Sep 1;59(5):666-75. PMID: 24867791.
• Lodise TP, Patel N, Lomaestro BM, Rodvold KA, Drusano G. Relationship between Initial Vancomycin Concentration-Time Profile and Nephrotoxicity among Hospitalized Patients. Clinical Infectious Diseases 2009 Aug 15;49(4):507-14. PMID: 19586413.
• van Hal SJ, Paterson DL, Lodise TP. Systematic review and meta-analysis of vancomycin-induced nephrotoxicity associated with dosing schedules that maintain troughs between 15 and 20 milligrams per liter. Antimicrob Agents Chemother. 2013 Feb;57(2):734-44. doi: 10.1128/AAC.01568-12. Epub 2012 Nov 19. Review. PubMed PMID: 23165462; PubMed Central PMCID: PMC3553731.
• Casapao AM, Lodise TP, Davis SL, Claeys KC, Kullar R, Levine DP, Rybak MJ. Association between vancomycin day 1 exposure profile and outcomes among patients with methicillin-resistant Staphylococcus aureus infective endocarditis. Antimicrob Agents Chemother. 2015 Jun;59(6):2978-85. doi: 10.1128/AAC.03970-14.Epub 2015 Mar 9. PubMed PMID: 25753631; PubMed Central PMCID: PMC4432113.

Dose optimization of antibiotics in critically ill patients with invasive infections.

There have been tremendous strides in our understanding of antibiotic exposure-response relationships over the past 25 years. For many antibiotics, the “pharmacodynamic” or the exposure variable associated with outcomes has been identified. I have applied our understanding of antimicrobial pharmacodynamics (PD) into clinical practice by designing empirical antibiotics regimens across specialized patient populations that have a high probability of achieving the PD target linked to effect through the use of population pharmacokinetic modeling and Monte Carlo simulation.

• Cardone KE, Chen WZ, Grabe DW, Batzold A, Manley HJ, Lodise TP. Evaluation of the pharmacodynamic profile of commonly used intravenous vancomycin dosing schemes in patients on automated peritoneal dialysis. Journal Antimicrobial Chemotherapy. 2014 Jul;69(7):1873-6. PMID: 24722842.
• Patel N, Scheetz MH, Drusano GL, Lodise TP. Identification of Optimal Renal Dosage Adjustments for Traditional and Extended Infusion Piperacillin/Tazobactam Dosing Regimens in Hospitalized Patients. Antimicrobial Agents and Chemotherapy. 2010 Jan;54(1):460-5. Epub 2009 Oct 26. PMID: 19858253. PMCID: PMC2798531.
• Butterfield JM, Mueller BA, Patel N, Cardone KE, Grabe DW, Salama NN, Lodise TP. Daptomycin pharmacokinetics and pharmacodynamics in a pooled sample of patients receiving thrice-weekly hemodialysis. Antimicrobial Agents and Chemotherapy. 2013 Feb;57(2):864-72. doi: 10.1128/AAC.02000-12. Epub 2012 Dec 3. PMID: 23208714. PMCID: PMC3553729.
• Patel N, Pai MP, Rodvold KA, Lomaestro BM, Drusano GL, Lodise TP. Vancomycin: We Can’t Get There from Here. Clinical Infectious Diseases. 2011 Apr 15;52(8):969-74. PMID: 21460308.

Epidemiology and outcomes of hospitalized patients with infections due to antibiotic resistant bacteria.

The prevalence of infections due to antibiotic resistant pathogens have increased dramatically over the last two decades and are a major public health threat among hospitalized patients throughout the world. Given the importance of early, appropriate therapy, my research focuses on the identification of patients at greatest risk for antibiotic infections. I also characterize the outcomes of patients with infections due to antibiotic resistant organisms.

• Lodise TP, Drusano GL, Lazariu V, El-Fawal N, Evans A, Graffunder E, Stellrecht K, Mendes RE, Jones RN, Cosler L, McNutt LA. Quantifying the matrix of relationships between reduced vancomycin susceptibility phenotypes and outcomes among patients with MRSA bloodstream infections treated with vancomycin . J Antimicrob Chemother. 2014 Sep;69(9):2547-55. doi: 10.1093/jac/dku135. Epub 2014 May 19. PubMed PMID: 24840624.
• Lodise TP, Graves J, Evans A, Graffunder E,  Helmecke M, Lomaestro BM, Stellrecht K.  Relationship between Vancomycin MIC and Failure among Patients with MRSA Bacteremia Treated with Vancomycin. Antimicrobial Agents and Chemotherapy 2008 Sep;52(9):3315-20. Epub 2008 Jun 30. PMID: 18591266. PMCID: PMC2533486.
• Patel N, McNutt LA, Lodise TP. Relationship between various definitions of prior antibiotic exposure and piperacillin-tazobactam resistance among patients with respiratory tract infections caused by Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2008 Aug;52(8):2933-6. PubMed PMID: 18519718; PubMed Central PMCID: PMC2493121.
• Lodise TP, Miller CD, Graves J, Furuno JP, McGregor JC, Lomaestro BM, Graffunder E, McNutt LA. Clinical Prediction Tool to Identify Patients with Pseudomonas aeruginosa Respiratory Tract Infections at Greatest Risk for Multi-Drug Resistance.  Antimicrobial Agents and Chemotherapy. 2007 Feb; 51(2):417-22. PMID: 17158943. PMCID: PMC1797724. 

Pharmacoepidemiologic and comparative effectiveness studies to determine optimal treatment strategies for patients with antibiotic resistant infections.

Currently, there are few completed clinical trials that define the optimal treatment strategies of patients with infections due to antibiotic resistant infections. There is high reliance on “real-world” pharmacoepidemiologic and comparative effectiveness studies to determine optimal management and treatment of infections due to antibiotic resistant pathogens. Through the use of state of art study design and statistical modeling techniques, my research uses real-world data to identify optimal treatment strategies that maximize the outcomes of patients with antibiotic resistant infections.     

• Lodise TP, Lomaestro BM, Graves J, Drusano GL. Larger Vancomycin Doses are Associated with an Increased Incidence of Nephrotoxicity. Antimicrobial Agents and Chemotherapy 2008 Apr;52(4); 1330-6. Epub 2008  Jan 28. PMID: 18227177. PMCID: PMC2292536
• Lodise TP, Lomaestro BM, Drusano GL. Piperacillin/Tazobactam for Pseudomonas aeruginosa Infections: Clinical Implications of an Extended Infusion Dosing Strategy. Clinical Infectious Diseases. 2007 Feb 1; 44(3):357-63. PMID: 17205441. 
• Patel GW, Patel N, Lat A, Trombley K, Enbawe S, Manor K, Smith R, Lodise TP Jr. Outcomes of extended infusion piperacillin/tazobactam for documented Gram-negative infections. Diagn Microbiol Infect Dis. 2009 Jun;64(2):236-40. doi: 10.1016/j.diagmicrobio.2009.03.002. PubMed PMID: 19500529.
• Lodise TP, McKinnon PS, Swiderski L, Rybak MJ. Outcomes analysis of delayed antibiotic treatment for hospital-acquired Staphylococcus aureus bacteremia. Clin Infect Dis. 2003 Jun 1;36(11):1418-23. Epub 2003 May 20. PubMed PMID: 12766837.

Conferences and Presentations

• LaPensee K, Lodise T. Cost-savings Analysis with Use of Omadacycline Among Hospitalized Community-Acquired Pneumonia Patients At Risk of Clostridium difficile Infection Being Treated with Moxifloxacin: Budget Impact Model Findings. ASHP Midyear Clinical Meeting, Anaheim CA, December 2-6, 2018. Poster #4-049. Presenter: LaPensee.
• LaPensee K, Lodise T. Cost-saving Opportunities Among Hospitalized Community-Acquired Pneumonia Patients Treated with Omadacycline, an Aminomethylcycline Antibiotic with IV and Oral Formulations, Compared to Ceftriaxone and Macrolide Therapy. ASHP Midyear Clinical Meeting, Anaheim CA, December 2-6, 2018. Poster #4-048. Presenter: LaPensee.
• Lodise T, LaPensee K. Hospital Admission Patterns in Adult Patients with Community-acquired Bacterial Pneumonia who Received Ceftriaxone and a Macrolide by Pneumonia Severity Index Score. IDweek2018, San Francisco CA, October 3-7, 2018. Abstract #1462. Presenter: Lodise.
• Patel N, Clark J, Stornelli N, Belfiore G, Lodise TP. Comparative Evaluation of Adverse Tendon Events between Recipients of Fluoroquinolones and Ceftriaxone/Azithromycin among Veterans Affairs Patients with Community Acquired Bacterial Pneumonia. IDweek2018, San Francisco CA, October 3-7, 2018. Abstract #1463. Presenter: Patel.
• Puzniak L, Fu R, Gundrum J, Lodise TP. Real World Evaluation of Patient Characteristics and Outcomes of Patients Treated with Ceftolozane/Tazobactam across 253 US hospitals. IDweek2018, San Francisco CA, October 3-7, 2018. Abstract # 2414. Presenter: Lodise.
• Lodise T, Packnett E, Armstrong S, Redell M. Comparisons of 30-Day Admission and 30-Day Total Healthcare Costs Between Patients Who Were Treated With Oritavancin (ORI) or Vancomycin (VAN) for a Skin Infection in the Outpatient Setting. IDweek2018, San Francisco CA, October 3-7, 2018. Abstract # 1928. Presenter: Lodise.
• Lodise TP, Bonine NG, Ye JM, Folse HJ, Gillard P. Development of a Bedside Tool to Predict the Probability of Drug-Resistant Pathogens among an Adult Population with Gram-Negative Infections. IDweek2018, San Francisco CA, October 3-7, 2018. Abstract # 1166. Presenter: Lodise.
• Saade E, Wilson B, El Chakhtoura NG, Viau R, Perez F, Lodise T, Bonomo RA. Drug-Induced Liver Injury (DILI) in a National Cohort of Hospitalized Patients treated with Aztreonam and Ceftazidime. IDweek2018, San Francisco CA, October 3-7, 2018. Abstract # 2409. Presenter: Saade.
• Cai B, Echols R, Corvino R, Lodise TP. Epidemiology and Outcomes of Patients with Carbapenem-Resistant Bloodstream Infection in United States (US) Hospitals, 2010-2015. IDweek2018, San Francisco CA, October 3-7, 2018. Abstract # 681. Presenter: Echols.
• Lodise TP, Smith NM, Holden P, O'Donnell JN, Bedard T, Bonomo RA, Tsuji BT. Efficacy of Ceftazidime-Avibactam in Combination with Aztreonam (COMBINE): Solutions for Metallo-β-lactamase producing-Enterobacteriaceae (MBL). IDweek2018, San Francisco CA, October 3-7, 2018. Abstract # 1385. Presenter: Tsuji.
• Avedissian S, Liu J, O'Donnell JN, Pais G, Becher L, Joshi M, Prozialeck W, Lamar P, Lodise TP, Scheetz MH. Poster presentation at IDweek2018™. San Francisco, CA. October 3-7, 2018. Abstract # 1419. Presenter: Avedissian.
• Rank E, Lodise TP, Avery L, Bankert E, Dobson E, Dumyati G, Hassett S, Keller M, Lubowski T, Pearsall M, Carreno J. New York State Outpatient Regional Antibiogram for Urinary Pathogens: Have We Reached a Post Antibiotic Era for the Treatment of UTIs? IDweek2018, San Francisco CA, October 3-7, 2018. Abstract # 1237. Presenter: Carreno.
• Huang D, Corey RG, Holland TL, Lodise TP, O'Rirodan W, Wilcox M, File TM, Dryden M, Torres A, Balser B, Desplats E. A Pooled Analysis of Patients with Wound Infections in 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. IDweek2018, San Francisco CA, October 3-7, 2018. Abstract # 1338. Presenter: Huang.
• Shorr A, Lodise T, Echols R, Wang W, Corvino FA, B. Cai B, Zilberberg M. Prevalence and Microbiology of Carbapenem Resistance Among Six Gram-Negative Pathogens in Bloodstream Infections in US Hospitals, 2010-2015. IDweek2018, San Francisco CA, October 3-7, 2018. Abstract # 1191. Presenter: Echols.
• Patel N, Sangiovanni R, Stornelli N, Amin R, Huang D, Lodise TP. Frequency of vancomycin-associated acute kidney injury and healthcare utilization among Veterans' Affairs patients with skin and skin structure infections. 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Madrid Spain, April 21-24, 2018. ePoster viewing #E0283. Presenter: Patel.
• Tartof S, Kuntz J, Chen L, Wei R, Puzniak L, Tian Y, Im T, Takhar H, Merchan S, Lodise TP. A clinical risk score to predict the likelihood of carbapenem non-susceptible and pan-beta-lactam non-susceptibility among adult, hospitalized patients with infections due to Pseudomonas aeruginosa. 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Madrid Spain, April 21-24, 2018. Oral flash #O0130. Presenter: Lodise.
• Patel N, Huang D, Lodise T. Potential cost savings opportunities with targeted iclaprim (ICL) compared to vancomycin (VAN) among hospitalized patients with acute bacterial skin and skin structure infectious due to potential avoidance of VAN-associated acute kidney injury. 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Madrid Spain, April 21-24, 2018. Paper poster #P0283. Presenter: Patel.
• Crass R, Lodise T, Pai M. Individualizing piperacillin/tazobactam dosing in adult patients with cystic fibrosis: can tobramycin measurements help? 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Madrid Spain, April 21-24, 2018. Paper poster #P0868. Presenter: Crass.

Extramural Grants

Role: Principal Investigator
Project Title: A Phase 1 Study In Healthy Young Adults To Evaluate The Safety And Pharmacokinetics Of AVYCAZ® In Combination With Aztreonam (COMBINE)
Grantor: Sub-award through Duke University; Primary sponsor: National Institute of Allergy and Infectious Diseases
Amount at ACPHS: $90,000
Grant Number: 1UM1AI104681-06
Term: 11/01/2018 – 12/31/2018

Role: Co-Investigator (PI: Richard Wunderlink, MD)
Project Title: An Open-Label Pharmacokinetic Study of Minocycline for Injection Following a Single Infusion in Critically-Ill Adults (Acumin)
Grantor: Sub-award through Duke University; Primary sponsor: National Institute of Allergy and Infectious Diseases
Grant Number: 1UM1AI104681-01 
Amount at ACPHS: $48,000
Term: 11/01/18 - 12/31/18

Role: Chair (PI: Vance Fowler, MD)
Project Title: PK ARLG Steering Committee Chair
Grantor: Sub-award through Duke University; Primary sponsor: National Institute of Allergy and Infectious Diseases
Grant Number: 1UM1AI104681-01 
Amount at ACPHS: $342,000
Term: 1/01/18- 12/31/18