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 - Journal of the American Medical Association

Volumn 319, Issue 8, 2018, Pages 788-799

  Kaye, Keith S ^a   Bhowmick, Tanaya ^a   Metallidis, Symeon ^b   Bleasdale, Susan C ^a   Sagan, Olexiy S ^b   Stus, Viktor ^c   Vazquez, Jose ^c   Zaitsev, Valerii ^d   Bidair, Mohamed ^d   Chorvat, Erik ^e   Dragoescu, Petru Octavian ^f   Fedosiuk, Elena ^g   Horcajada, Juan P ^h   Murta, Claudia ⁱ   Sarychev, Yaroslav ^j   Stoev, Ventsislav ^k   Morgan, Elizabeth ^l   Fusaro, Karen ^j,m   Griffith, David ⁿ   Lomovskaya, Olga ^j   Alexander, Elizabeth L ^o   Loutit, Jeffery ^p   Dudley, Michael N ^q   Giamarellos Bourboulis, Evangelos J ^r   more..

^a UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^b ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

^c ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

^d UNIVERSITY OF ILLINOIS   (United States)

^e Regional Clinical Hospital of Zaporizhizhia   (Ukraine)

^f Ministry of Health of Ukraine   (Ukraine)

^g MEDICAL COLLEGE OF GEORGIA   (United States)

^h BUKOVINIAN STATE MEDICAL UNIVERSITY   (Ukraine)

ⁱ San Diego Arthritis Medical Clinic   (United States)

^j Urologicke Oddelenie NSP ^*  (Bulgaria)

^k University Emergency County Hospital Craiova   (Romania)

^l Brest Regional Hospital   (Belarus)

^m HOSPITAL DEL MAR   (Spain)

ⁿ UKRAINIAN MEDICAL STOMATOLOGICAL ACADEMY   (Ukraine)

^o Medicines Company   (United States)

^p Melinta Therapeutics Inc   (United States)

^q MEDICINES COMPANY   (United States)

^r UNIVERSITY OF ATHENS   (Greece)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; LEVOFLOXACIN; MEROPENEM PLUS VABORBACTAM; PIPERACILLIN PLUS TAZOBACTAM; ANTIINFECTIVE AGENT; MEROPENEM; PENICILLANIC ACID; PIPERACILLIN; PIPERACILLIN, TAZOBACTAM DRUG COMBINATION; THIENAMYCIN DERIVATIVE;

ACUTE PYELONEPHRITIS; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASYMPTOMATIC BACTERIURIA; CATHETER SITE PHLEBITIS; CATHETER SITE PHLEBITISC; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; EUROPEAN MEDICINES AGENCY; FEMALE; FEVER; FOOD AND DRUG ADMINISTRATION; HEADACHE; HUMAN; HYPOKALEMIA; INFUSION SITE PHLEBITIS; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; NAUSEA; PATHOGEN CLEARANCE; PHASE 3 CLINICAL TRIAL; PHLEBITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TREATMENT DURATION; TREATMENT OUTCOME; URINARY TRACT INFECTION; VAGINITIS; ACUTE DISEASE; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; COMPARATIVE STUDY; DRUG COMBINATION; MICROBIOLOGY; PRACTICE GUIDELINE; PYELONEPHRITIS; URINE;

ACUTE DISEASE; ADULT; AGED; ANTI-BACTERIAL AGENTS; DRUG COMBINATIONS; FEMALE; HUMANS; INTENTION TO TREAT ANALYSIS; MALE; MIDDLE AGED; PENICILLANIC ACID; PIPERACILLIN; PRACTICE GUIDELINES AS TOPIC; PYELONEPHRITIS; THIENAMYCINS; URINARY TRACT INFECTIONS; URINE;

EID: 85042594840     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2018.0438     Document Type: Article

References (28)

1. Falagas ME, Lourida P, Poulikakos P, Rafailidis PI, Tansarli GS. Antibiotic treatment of infections due to carbapenem-resistant Enterobacteriaceae: systematic evaluation of the available evidence. Antimicrob Agents Chemother. 2014;58(2):654-663.
2. Tamma PD, Avdic E, Keenan JF, et al. What is the more effective antibiotic stewardship intervention: preprescription authorization or postprescription review with feedback? Clin Infect Dis. 2017;64(5): 537-543.
3. Centers for Disease Control and Prevention (CDC). Antibiotic resistance threats in the United States, 2013. CDC website. https://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-Threats-2013-508.pdf. Accessed April 30, 2017.
4. World Health Organization (WHO). Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. WHO website. http://www.who.int/medicines/publications/global-priority-list-Antibiotic-resistant-bacteria/en/. Accessed April 30, 2017.
5. Lee C-R, Lee JH, Park KS, Kim YB, Jeong BC, Lee SH. Global dissemination of carbapenemaseproducing Klebsiella pneumoniae: Epidemiology, genetic context, treatment options, and detection methods. Front Microbiol. 2016;7:895.
6. Alexander EL, Loutit J, Tumbarello M, et al. Carbapenem-resistant Enterobacteriaceae infections: Results from a retrospective series and implications for the design of prospective clinical trials. Open Forum Infect Dis. 2017;4(2):ofx063.
7. 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.
8. Levison ME, Kaye D. Treatment of complicated urinary tract infections with an emphasis on drug-resistant gram-negative uropathogens. Curr Infect Dis Rep. 2013;15(2):109-115.
9. Tumbarello M, Viale P, Viscoli C, et al. Predictors of mortality in bloodstream infections caused by Klebsiella pneumoniae carbapenemase-producing K. pneumoniae: importance of combination therapy. Clin Infect Dis. 2012;55(7):943-950.
10. Falagas ME, Tansarli GS, Karageorgopoulos DE, Vardakas KZ. Deaths attributable to carbapenem-resistant Enterobacteriaceae infections. Emerg Infect Dis. 2014;20(7):1170-1175.
11. Tzouvelekis LS, Markogiannakis A, Piperaki E, Souli M, Daikos GL. Treating infections caused by carbapenemase-producing Enterobacteriaceae. Clin Microbiol Infect. 2014;20(9):862-872.
12. Tarazi Z, Sabet M, Rubio-Aparicio D, et al. Efficacy of simulated human exposures of Carbavance (meropenem-RPX7009) against carbapenem-resistant Enterobacteriaceae in an in vitro hollow fiber model. Presented at: 54th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 5-9, 2014; Washington, DC.
13. Tarazi Z, Sabet M, Rubio-Aparicio D, et al. Efficacy of simulated human exposures of meropenem compared to Carbavance (meropenem-RPX7009) against Pseudomonas aeruginosa in an in vitro hollow fiber model. Presented at: 25th European Congress of Clinical Microbriology and Infectious Diseases; April 25-28, 2015; Copenhagen, Denmark.
14. Wenzler E, Gotfried MH, Loutit JS, et al. Meropenem-RPX7009 concentrations in plasma, epithelial lining fluid, and alveolar macrophages of healthy adult subjects. Antimicrob Agents Chemother. 2015; 59(12):7232-7239.
15. Griffith DC, Rubino CM, Loutit JS, et al. A phase 1 study of the safety, tolerability, and pharmacokinetics of the beta-lactamase inhibitor RPX7009 alone, meropenem alone, and both in combination TID for 7 days in healthy adult subjects (poster 401). Presented at: IDWeek; October 8-12, 2014; Philadelphia, PA.
16. US Food and Drug Administration (FDA). Complicated urinary tract infections: developing drugs for treatment: guidance for industry. FDA website. https://www.fda.gov/downloads/Drugs/Guidances/ucm070981.pdf. February 2015. Accessed November 15, 2017.
17. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Seventh Informational Supplement, M100-S27.Wayne, PA: Clinical and Laboratory Standards Institute; 2017.
18. Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard: M07-A10. 10th ed.Wayne, PA: Clinical and Laboratory Standards Institute; 2015.
19. European Medicines Agency. Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2013/11/WC500153953.pdf. October 24, 2013. Accessed November 15, 2017.
20. Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4(2):213-226.
21. US Food and Drug Administration (FDA). Guidance for Industry. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases: guidance for industry. FDA website. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM359184.pdf. August 2017. Accessed December 7, 2017.
22. European Committee on Antimicrobial Susceptibility Testing (EUCAST). EUCAST criteria. EUCAST website. http://www.eucast.org/. Accessed November 17, 2017.
23. Sader HS, Castanheira M, Flamm RK, Jones RN. Antimicrobial activities of ceftazidime-Avibactam and comparator agents against gram-negative organisms isolated from patients with urinary tract infections in U.S. medical centers, 2012 to 2014. Antimicrob Agents Chemother. 2016;60(7):4355- 4360.
24. Magill SS, Edwards JR, Beldavs ZG, et al; Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team. Prevalence of antimicrobial use in US acute care hospitals, May-September 2011. JAMA. 2014;312 (14):1438-1446.
25. Linden P. Safety profile of meropenem: An updated review of over 6, 000 patients treated with meropenem. Drug Saf. 2007;30(8):657-668.
26. Mohr JF III. Update on the efficacy and tolerability of meropenem in the treatment of serious bacterial infections. Clin Infect Dis. 2008;47 (suppl 1):S41-S51.
27. Wagenlehner FM, Sobel JD, Newell P, et al. Ceftazidime-Avibactam versus doripenem for the treatment of complicated urinary tract infections, including acute pyelonephritis: RECAPTURE, a phase 3 randomized trial program. Clin Infect Dis. 2016;63(6):754-762.
28. Wagenlehner FM, Umeh O, Steenbergen J, Yuan G, Darouiche RO. Ceftolozane-Tazobactam compared with levofloxacin in the treatment of complicated urinary-Tract infections, including pyelonephritis: A randomised, double-blind, phase 3 trial (ASPECT-cUTI). Lancet. 2015; 385 (9981): 1949-1956.