719
Views
3
CrossRef citations to date
0
Altmetric
REVIEW

Unmet Needs in Complicated Urinary Tract Infections: Challenges, Recommendations, and Emerging Treatment Pathways

&
Pages 1391-1405 | Received 16 Dec 2022, Accepted 24 Feb 2023, Published online: 11 Mar 2023

References

  • Wagenlehner FME, Bjerklund Johansen TE, Cai T, et al. Epidemiology, definition and treatment of complicated urinary tract infections. Nat Rev Urol. 2020;17(10):586–600. doi:10.1038/s41585-020-0362-4
  • Simmering JE, Tang F, Cavanaugh JE, Polgreen LA, Polgreen PM. The increase in hospitalizations for urinary tract infections and the associated costs in the United States, 1998–2011. Open Forum Infect Dis. 2017;4(1):ofw281. doi:10.1093/ofid/ofw281
  • Zilberberg MD, Nathanson BH, Sulham K, Shorr AF. Descriptive epidemiology and outcomes of hospitalizations with complicated urinary tract infections in the United States, 2018. Open Forum Infect Dis. 2022;9(1):ofab591. doi:10.1093/ofid/ofab591
  • Tackling drug-resistant infections globally: final report and recommendations / the review on antimicrobial resistance chaired by Jim O’Neill. Wellcome Collection. Available from: https://wellcomecollection.org/works/thvwsuba. Accessed September 18, 2022.
  • Smith R, Coast J. The true cost of antimicrobial resistance. BMJ. 2013;346:f1493. doi:10.1136/bmj.f1493
  • Anger J, Lee U, Ackerman AL, et al. Recurrent uncomplicated urinary tract infections in women: AUA/CUA/SUFU guideline. J Urol. 2019;202(2):282–289. doi:10.1097/JU.0000000000000296
  • Johansen TEB, Botto H, Cek M, et al. Critical review of current definitions of urinary tract infections and proposal of an EAU/ESIU classification system. Int J Antimicrob Agents. 2011;38:64–70. doi:10.1016/j.ijantimicag.2011.09.009
  • US Food and Drug Administration. Complicated urinary tract infections: developing drugs for treatment; 2020. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/complicated-urinary-tract-infections-developing-drugs-treatment. Accessed September 18, 2022.
  • EMA. Evaluation of medicinal products indicated for treatment bacterial infections - scientific guideline. European Medicines Agency; 2018. Available from: https://www.ema.europa.eu/en/evaluation-medicinal-products-indicated-treatment-bacterial-infections-scientific-guideline. Accessed November 11, 2022.
  • Flores-Mireles AL, Walker JN, Caparon M, Hultgren SJ. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nat Rev Microbiol. 2015;13(5):269–284. doi:10.1038/nrmicro3432
  • Zilberberg MD, Nathanson BH, Sulham K, Fan W, Shorr AF. Development and validation of a bedside instrument to predict carbapenem resistance among gram-negative pathogens in complicated urinary tract infections. Infect Control Hosp Epidemiol. 2018;39(9):1112–1114. doi:10.1017/ice.2018.166
  • Zowawi HM, Harris PNA, Roberts MJ, et al. The emerging threat of multidrug-resistant gram-negative bacteria in urology. Nat Rev Urol. 2015;12(10):570–584. doi:10.1038/nrurol.2015.199
  • Gomila A, Shaw E, Carratalà J, et al. Predictive factors for multidrug-resistant gram-negative bacteria among hospitalised patients with complicated urinary tract infections. Antimicrob Resist Infect Control. 2018;7(1):111. doi:10.1186/s13756-018-0401-6
  • Tandoğdu Z, Bartoletti R, Cai T, et al. Antimicrobial resistance in urosepsis: outcomes from the multinational, multicenter global prevalence of infections in urology (GPIU) study 2003–2013. World J Urol. 2016;34(8):1193–1200. doi:10.1007/s00345-015-1722-1
  • Fleming-Dutra KE, Hersh AL, Shapiro DJ, et al. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, 2010–2011. JAMA. 2016;315(17):1864–1873. doi:10.1001/jama.2016.4151
  • Langner JL, Chiang KF, Stafford RS. Current prescribing practices and guideline concordance for the treatment of uncomplicated urinary tract infections in women. Am J Obstet Gynecol. 2021;225(3):272.e1–272.e11. doi:10.1016/j.ajog.2021.04.218
  • Mohareb AM, Letourneau AR, Sánchez SM, Walensky RP, Hyle EP. Addressing antibiotic overuse in the outpatient setting: lessons from behavioral economics. Mayo Clin Proc. 2021;96(3):537–542. doi:10.1016/j.mayocp.2020.10.033
  • Daniel M, Keller S, Mozafarihashjin M, Pahwa A, Soong C. An implementation guide to reducing overtreatment of asymptomatic bacteriuria. JAMA Intern Med. 2018;178(2):271–276. doi:10.1001/jamainternmed.2017.7290
  • Bonnal C, Baune B, Mion M, et al. Bacteriuria in a geriatric hospital: impact of an antibiotic improvement program. J Am Med Dir Assoc. 2008;9(8):605–609. doi:10.1016/j.jamda.2008.04.004
  • Renwick MJ, Simpkin V, Mossialos E. Targeting innovation in antibiotic drug discovery and development: the need for a one health – one Europe – one world framework. European Observatory on Health Systems and Policies; 2016. Available from: http://www.ncbi.nlm.nih.gov/books/NBK447337/. Accessed September 18, 2022.
  • Flores-Mireles A, Hreha TN, Hunstad DA. Pathophysiology, treatment, and prevention of catheter-associated urinary tract infection. Top Spinal Cord Inj Rehabil. 2019;25(3):228–240. doi:10.1310/sci2503-228
  • Werneburg GT, Nguyen A, Henderson NS, et al. The natural history and composition of urinary catheter biofilms: early uropathogen colonization with intraluminal and distal predominance. J Urol. 2020;203(2):357–364. doi:10.1097/JU.0000000000000492
  • Hooton TM, Bradley SF, Cardenas DD, et al. Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 international clinical practice guidelines from the infectious diseases society of America. Clin Infect Dis. 2010;50(5):625–663. doi:10.1086/650482
  • Loeb M, Bentley DW, Bradley S, et al. Development of minimum criteria for the initiation of antibiotics in residents of long-term–care facilities: results of a consensus conference. Infect Control Hosp Epidemiol. 2001;22(2):120–124. doi:10.1086/501875
  • Trautner BW, Petersen NJ, Hysong SJ, Horwitz D, Kelly PA, Naik AD. Overtreatment of asymptomatic bacteriuria: identifying provider barriers to evidence-based care. Am J Infect Control. 2014;42(6):653–658. doi:10.1016/j.ajic.2014.02.003
  • Zabarsky TF, Sethi AK, Donskey CJ. Sustained reduction in inappropriate treatment of asymptomatic bacteriuria in a long-term care facility through an educational intervention. Am J Infect Control. 2008;36(7):476–480. doi:10.1016/j.ajic.2007.11.007
  • Morton SC, Shekelle PG, Adams JL, et al. Antimicrobial prophylaxis for urinary tract infection in persons with spinal cord dysfunction. Arch Phys Med Rehabil. 2002;83(1):129–138. doi:10.1053/apmr.2002.26605
  • Lo E, Nicolle LE, Coffin SE, et al. Strategies to prevent catheter-associated urinary tract infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014;35(5):464–479. doi:10.1086/675718
  • Hoberman A, Greenfield SP, et al; RIVUR Trial Investigators. Antimicrobial prophylaxis for children with vesicoureteral reflux. N Engl J Med. 2014;370(25):2367–2376. doi:10.1056/NEJMoa1401811
  • Tandogdu Z, Cai T, Koves B, Wagenlehner F, Bjerklund-Johansen TE. Urinary tract infections in immunocompromised patients with diabetes, chronic kidney disease, and kidney transplant. Eur Urol Focus. 2016;2(4):394–399. doi:10.1016/j.euf.2016.08.006
  • Geerlings SE, Meiland R, Hoepelman AIM. Pathogenesis of bacteriuria in women with diabetes mellitus. Int J Antimicrob Agents. 2002;19(6):539–545. doi:10.1016/s0924-8579(02)00090-0
  • Venmans LMAJ, Sloof M, Hak E, Gorter KJ, Rutten GEHM. Prediction of complicated urinary tract infections in patients with type 2 diabetes: a questionnaire study in primary care. Eur J Epidemiol. 2007;22(1):49. doi:10.1007/s10654-006-9077-y
  • van der Starre WE, Borgdorff H, Vollaard AM, et al. Diabetes and the course of febrile urinary tract infection. Diabetes Care. 2013;36(12):e193–e194. doi:10.2337/dc13-0903
  • Singh M, Sharma R, Kumar A. Safety of SGLT2 inhibitors in patients with diabetes mellitus. Curr Drug Saf. 2019;14(2):87–93. doi:10.2174/1574886314666190206164647
  • Chao CT, Lee SY, Wang J, Chien KL, Huang JW. Frailty increases the risk for developing urinary tract infection among 79,887 patients with diabetic mellitus and chronic kidney disease. BMC Geriatr. 2021;21(1):349. doi:10.1186/s12877-021-02299-3
  • Säemann M, Hörl WH. Urinary tract infection in renal transplant recipients. Eur J Clin Invest. 2008;38(Suppl 2):58–65. doi:10.1111/j.1365-2362.2008.02014.x
  • Fiorentino M, Pesce F, Schena A, Simone S, Castellano G, Gesualdo L. Updates on urinary tract infections in kidney transplantation. J Nephrol. 2019;32(5):751–761. doi:10.1007/s40620-019-00585-3
  • Senger SS, Arslan H, Azap OK, Timurkaynak F, Cağir U, Haberal M. Urinary tract infections in renal transplant recipients. Transplant Proc. 2007;39(4):1016–1017. doi:10.1016/j.transproceed.2007.02.060
  • Abbott KC, Swanson SJ, Richter ER, et al. Late urinary tract infection after renal transplantation in the United States. Am J Kidney Dis. 2004;44(2):353–362. doi:10.1053/j.ajkd.2004.04.040
  • Pellé G, Vimont S, Levy PP, et al. Acute pyelonephritis represents a risk factor impairing long-term kidney graft function. Am J Transplant. 2007;7(4):899–907. doi:10.1111/j.1600-6143.2006.01700.x
  • El Amari EB, Hadaya K, Bühler L, et al. Outcome of treated and untreated asymptomatic bacteriuria in renal transplant recipients. Nephrol Dial Transplant. 2011;26(12):4109–4114. doi:10.1093/ndt/gfr198
  • Green H, Rahamimov R, Gafter U, Leibovitci L, Paul M. Antibiotic prophylaxis for urinary tract infections in renal transplant recipients: a systematic review and meta-analysis. Transpl Infect Dis. 2011;13(5):441–447. doi:10.1111/j.1399-3062.2011.00644.x
  • Ziakas PD, Pliakos EE, Zervou FN, Knoll BM, Rice LB, Mylonakis E. MRSA and VRE colonization in solid organ transplantation: a meta-analysis of published studies. Am J Transplant. 2014;14(8):1887–1894. doi:10.1111/ajt.12784
  • Köves B, Cai T, Veeratterapillay R, et al. Benefits and harms of treatment of asymptomatic bacteriuria: a systematic review and meta-analysis by the European Association of urology urological infection guidelines panel. Eur Urol. 2017;72(6):865–868. doi:10.1016/j.eururo.2017.07.014
  • Bookstaver PB, Bland CM, Griffin B, Stover KR, Eiland LS, McLaughlin M. A review of antibiotic use in pregnancy. Pharmacotherapy. 2015;35(11):1052–1062. doi:10.1002/phar.1649
  • López-Montesinos I, Horcajada JP. Oral and intravenous fosfomycin in complicated urinary tract infections. Rev Esp Quimioter. 2019;32(Suppl 1):37–44.
  • Qiao LD, Zheng B, Chen S, et al. Evaluation of three-dose fosfomycin tromethamine in the treatment of patients with urinary tract infections: an uncontrolled, open-label, multicentre study. BMJ Open. 2013;3(12):e004157. doi:10.1136/bmjopen-2013-004157
  • Senol S, Tasbakan M, Pullukcu H, et al. Carbapenem versus fosfomycin tromethanol in the treatment of extended-spectrum beta-lactamase-producing Escherichia coli-related complicated lower urinary tract infection. J Chemother. 2010;22(5):355–357. doi:10.1179/joc.2010.22.5.355
  • Pullukcu H, Tasbakan M, Sipahi OR, Yamazhan T, Aydemir S, Ulusoy S. Fosfomycin in the treatment of extended spectrum beta-lactamase-producing Escherichia coli-related lower urinary tract infections. Int J Antimicrob Agents. 2007;29(1):62–65. doi:10.1016/j.ijantimicag.2006.08.039
  • Kaye KS, Rice LB, Dane AL, et al. Fosfomycin for injection (ZTI-01) versus piperacillin-tazobactam for the treatment of complicated urinary tract infection including acute pyelonephritis: ZEUS, a phase 2/3 randomized trial. Clin Infect Dis. 2019;69(12):2045–2056. doi:10.1093/cid/ciz181
  • NADAC (National Average Drug Acquisition Cost); 2022. Available from: https://data.medicaid.gov/dataset/dfa2ab14-06c2-457a-9e36-5cb6d80f8d93. Accessed November 14, 2022.
  • Kassabian M, Calderwood MS, Ohsfeldt R. A cost-effectiveness analysis of fosfomycin: a single-dose antibiotic therapy for treatment of uncomplicated urinary tract infection. Health Serv Insights. 2022;15:11786329221126340. doi:10.1177/11786329221126340
  • Sadler S, Holmes M, Ren S, Holden S, Jha S, Thokala P. Cost-effectiveness of antibiotic treatment of uncomplicated urinary tract infection in women: a comparison of four antibiotics. BJGP Open. 2017;1(3). doi:10.3399/bjgpopen17X101097
  • Ong A, Pietropaolo A, Brown G, Somani BK. Are intravesical aminoglycosides the new gold standard in the management of refractory urinary tract infection: a systematic review of literature. J Clin Med. 2022;11(19):5703. doi:10.3390/jcm11195703
  • Pietropaolo A, Jones P, Moors M, Birch B, Somani BK. Use and effectiveness of antimicrobial intravesical treatment for prophylaxis and treatment of recurrent Urinary Tract Infections (UTIs): a systematic review. Curr Urol Rep. 2018;19(10):78. doi:10.1007/s11934-018-0834-8
  • Cox L, He C, Bevins J, Clemens JQ, Stoffel JT, Cameron AP. Gentamicin bladder instillations decrease symptomatic urinary tract infections in neurogenic bladder patients on intermittent catheterization. Can Urol Assoc J. 2017;11(9):E350–E354. doi:10.5489/cuaj.4434
  • Andretta E, Longo R, Balladelli M, Sgarabotto C, Sgarabotto D. Intravesical gentamicin: an option for therapy and prophylaxis against recurrent UTIs and resistant bacteria in neurogenic bladder patients on intermittent catheterization. Antibiotics. 2022;11(10):1335. doi:10.3390/antibiotics11101335
  • Cicione A, Cantiello F, Ucciero G, et al. Intravesical treatment with highly-concentrated hyaluronic acid and chondroitin sulphate in patients with recurrent urinary tract infections: results from a multicentre survey. Can Urol Assoc J. 2014;8(9–10):E721–E727. doi:10.5489/cuaj.1989
  • Wagenlehner FME, Tandogdu Z, Bjerklund Johansen TE. An update on classification and management of urosepsis. Curr Opin Urol. 2017;27(2):133–137. doi:10.1097/MOU.0000000000000364
  • Portsmouth S, Bass A, Echols R, Tillotson G. Heterogeneity of recent phase 3 complicated urinary tract infection clinical trials. Open Forum Infect Dis. 2021;8(3):ofab045. doi:10.1093/ofid/ofab045
  • Malaisri C, Phuphuakrat A, Wibulpolprasert A, Santanirand P, Kiertiburanakul S. A randomized controlled trial of sitafloxacin vs. ertapenem as a switch therapy after treatment for acute pyelonephritis caused by extended-spectrum β-lactamase-producing Escherichia coli: a pilot study. J Infect Chemother. 2017;23(8):556–562. doi:10.1016/j.jiac.2017.05.005
  • Seo YB, Lee J, Kim YK, et al. Randomized controlled trial of piperacillin-tazobactam, cefepime and ertapenem for the treatment of urinary tract infection caused by extended-spectrum beta-lactamase-producing Escherichia coli. BMC Infect Dis. 2017;17(1):404. doi:10.1186/s12879-017-2502-x
  • Kaye KS, Bhowmick T, Metallidis S, et al. Effect of meropenem-vaborbactam vs piperacillin-tazobactam on clinical cure or improvement and microbial eradication in complicated urinary tract infection: the TANGO I randomized clinical trial. JAMA. 2018;319(8):788–799. doi:10.1001/jama.2018.0438
  • Harris PNA, Tambyah PA, Lye DC, et al. Effect of piperacillin-tazobactam vs meropenem on 30-day mortality for patients with E coli or Klebsiella pneumoniae bloodstream infection and ceftriaxone resistance: a randomized clinical trial. JAMA. 2018;320(10):984–994. doi:10.1001/jama.2018.12163
  • Portsmouth S, Veenhuyzen D, Echols R, et al. Cefiderocol versus imipenem-cilastatin for the treatment of complicated urinary tract infections caused by gram-negative uropathogens: a phase 2, randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2018;18(12):1319–1328. doi:10.1016/S1473-3099(18)30554-1
  • Bassetti M, Echols R, Matsunaga Y, et al. Efficacy and safety of cefiderocol or best available therapy for the treatment of serious infections caused by carbapenem-resistant gram-negative bacteria (CREDIBLE-CR): a randomised, open-label, multicentre, pathogen-focused, descriptive, phase 3 trial. Lancet Infect Dis. 2021;21(2):226–240. doi:10.1016/S1473-3099(20)30796-9
  • The Joint Commission. New and revised requirements addressing antibiotic stewardship for the hospital and critical access hospital programs. Available from: https://www.jointcommission.org/standards/prepublication-standards/new-and-revised-requirements-addressing-antibiotic-stewardship-for-hospital/. Accessed September 19, 2022.
  • XERAVA (eravacycline) for injection [package insert]. Tetraphase Pharm. Waltham, MA; 2018.
  • GlobeNewswire News Room. Tetraphase announces top-line results from IGNITE3 phase 3 clinical trial of eravacycline in complicated Urinary Tract Infections (cUTI); 2018. Available from: https://www.globenewswire.com/news-release/2018/02/13/1340188/34757/en/Tetraphase-Announces-Top-Line-Results-from-IGNITE3-Phase-3-Clinical-Trial-of-Eravacycline-in-Complicated-Urinary-Tract-Infections-cUTI.html. Accessed November 14, 2022.
  • Motsch J, Murta de Oliveira C, Stus V, et al. RESTORE-IMI 1: a multicenter, randomized, double-blind trial comparing efficacy and safety of imipenem/relebactam vs colistin plus imipenem in patients with imipenem-nonsusceptible bacterial infections. Clin Infect Dis. 2020;70(9):1799–1808. doi:10.1093/cid/ciz530
  • George Sakoulas MD. FDA approves imipenem-cilastatin/relebactam (recarbrio) for complicated intra-abdominal or urinary tract infections. NEJM J Watch. 2019;2019. doi:10.1056/nejm-jw.NA49571
  • Wagenlehner FME, Cloutier DJ, Komirenko AS, et al. Once-daily plazomicin for complicated urinary tract infections. N Engl J Med. 2019;380(8):729–740. doi:10.1056/NEJMoa1801467
  • Inc A. ZEMDRITM (plazomicin) approved by FDA for the treatment of adults with complicated Urinary Tract Infections (cUTI). GlobeNewswire News Room; 2018. Available from: https://www.globenewswire.com/news-release/2018/06/26/1529573/30133/en/ZEMDRITM-plazomicin-Approved-by-FDA-for-the-Treatment-of-Adults-with-Complicated-Urinary-Tract-Infections-cUTI.html. Accessed December 2, 2022.
  • Kaye KS, Belley A, Barth P, et al. Effect of cefepime/enmetazobactam vs piperacillin/tazobactam on clinical cure and microbiological eradication in patients with complicated urinary tract infection or acute pyelonephritis: a randomized clinical trial. JAMA. 2022;328(13):1304–1314. doi:10.1001/jama.2022.17034
  • Allecra therapeutics publishes final phase 3 ALLIUM data in JAMA: cefepime/enmetazobactam met criteria for superiority; 2022. Available from: https://www.businesswire.com/news/home/20221005005413/en/Allecra-Therapeutics-Publishes-Final-Phase-3-ALLIUM-Data-in-JAMA-CefepimeEnmetazobactam-Met-Criteria-for-Superiority. Accessed December 2, 2022.
  • Eckburg PB, Muir L, Critchley IA, et al. Oral tebipenem pivoxil hydrobromide in complicated urinary tract infection. N Engl J Med. 2022;386(14):1327–1338. doi:10.1056/NEJMoa2105462
  • Duffy S. FDA needs more data on tebipenem HBr for complicated UTI. MPR; 2022. Available from: https://www.empr.com/home/news/drugs-in-the-pipeline/fda-needs-more-data-on-tebipenem-hbr-for-complicated-uti/. Accessed November 14, 2022.
  • Rex JH, Eisenstein BI, Alder J, et al. A comprehensive regulatory framework to address the unmet need for new antibacterial treatments. Lancet Infect Dis. 2013;13(3):269–275. doi:10.1016/S1473-3099(12)70293-1
  • IMI Innovative Medicines Initiative. ND4BB | new drugs for bad bugs. IMI Innovative Medicines Initiative. Available from: http://www.imi.europa.eu/projects-results/project-factsheets/nd4bb. Accessed September 18, 2022.
  • Gingrey P. H.R.2182-112th congress (2011–2012): generating antibiotic incentives now act of 2011; 2011. Available from: http://www.congress.gov/. Accessed September 18, 2022.
  • FDA. Limited population pathway for antibacterial and antifungal drugs – the LPAD pathway; 2020. Available from: https://www.fda.gov/drugs/development-resources/limited-population-pathway-antibacterial-and-antifungal-drugs-lpad-pathway. Accessed November 14, 2022.
  • Turner KM, Christensen H, Adams EJ, et al. Analysis of the potential for point-of-care test to enable individualised treatment of infections caused by antimicrobial-resistant and susceptible strains of Neisseria gonorrhoeae: a modelling study. BMJ Open. 2017;7(6):e015447. doi:10.1136/bmjopen-2016-015447
  • Wojno KJ, Baunoch D, Luke N, et al. Multiplex PCR based Urinary Tract Infection (UTI) analysis compared to traditional urine culture in identifying significant pathogens in symptomatic patients. Urology. 2020;136:119–126. doi:10.1016/j.urology.2019.10.018
  • Elligsen M, Pinto R, Leis JA, Walker SAN, Daneman N, MacFadden DR. Improving Decision Making in Empiric Antibiotic Selection (IDEAS) for gram-negative bacteremia: a prospective clinical implementation study. Clin Infect Dis. 2021;73(2):e417–e425. doi:10.1093/cid/ciaa921
  • Gupta K, Hooton TM, Naber KG, et al. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: a 2010 update by the infectious diseases society of America and the European society for microbiology and infectious diseases. Clin Infect Dis. 2011;52(5):e103–e120. doi:10.1093/cid/ciq257
  • Medical student curriculum: adult UTI - American Urological Association. Available from: https://www.auanet.org/meetings-and-education/for-medical-students/medical-students-curriculum/adult-uti. Accessed December 1, 2022.
  • Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009;9(Suppl 3):S1–S155. doi:10.1111/j.1600-6143.2009.02834.x
  • Al Midani A, Elands S, Collier S, Harber M, Shendi AM. Impact of urinary tract infections in kidney transplant recipients: a 4-year single-center experience. Transplant Proc. 2018;50(10):3351–3355. doi:10.1016/j.transproceed.2018.08.022
  • VABOMERE (meropenem and vaborbactam) for injection [package insert]. Melinta Ther. Parisppany New Jersey; 2017.
  • FDA. FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance; 2020. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibacterial-drug-treat-complicated-urinary-tract-infections-part-ongoing-efforts. Accessed December 2, 2022.