Pharmacokinetics, safety, and tolerability of cefiderocol, a novel siderophore cephalosporin for gram-negative bacteria, in healthy subjects

Antimicrobial Agents and Chemotherapy

Volumn 62, Issue 3, 2018, Pages

  Saisho, Yutaka ^a   Katsube, Takayuki ^a   White, Scott ^b,d   Fukase, Hiroyuki ^c,d,e   Shimada, Jingoro ^a  

^a SHIONOGI AND CO LTD   (Japan)

^b GLAXOSMITHKLINE   (United States)

^c CPC Clinical Trial Hospital   (Japan)

^d Inovio Pharmaceuticals   (United States)

^e Section of Studies   (Japan)

Author keywords

Cefiderocol; Cephalosporin; Gram negative bacteria; Pharmacokinetics; Siderophores

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CEFIDEROCOL; CREATINE KINASE; GLUCOSE; PLACEBO; THYROTROPIN; ANTIINFECTIVE AGENT; CEPHALOSPORIN DERIVATIVE; SIDEROPHORE;

ABDOMINAL PAIN; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIBACTERIAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CAUCASIAN; COHORT ANALYSIS; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DIARRHEA; DIZZINESS; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE INCREASE; DRUG ERUPTION; DRUG EXCRETION; DRUG INDUCED HEADACHE; DRUG INFUSION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELIMINATION HALF-LIFE; ERYTHROCYTE COUNT; FEMALE; FEVER; GASTROINTESTINAL DISEASE; GLUCOSE BLOOD LEVEL; GRAM NEGATIVE BACTERIUM; HUMAN; HUMAN EXPERIMENT; HYPERGLYCEMIA; HYPERTRANSAMINASEMIA; JAPANESE (PEOPLE); LEUKOCYTE COUNT; LEUKOPENIA; MALE; MAXIMUM CONCENTRATION; MEAN RESIDENCE TIME; MEDIASTINUM DISEASE; NAUSEA; NEUROLOGIC DISEASE; NORMAL HUMAN; OROPHARYNX PAIN; PHARMACOKINETIC PARAMETERS; PLASMA CONCENTRATION-TIME CURVE; PLASMA HALF LIFE; PRIORITY JOURNAL; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SINGLE DRUG DOSE; SKIN DISEASE; THYROTROPIN BLOOD LEVEL; UPPER RESPIRATORY TRACT INFECTION; URINARY EXCRETION; YOUNG ADULT; BLOOD; CLINICAL TRIAL; DOSE CALCULATION; DRUG ADMINISTRATION; HALF LIFE TIME; JAPAN; MIDDLE AGED; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; URINE;

ADULT; ANTI-BACTERIAL AGENTS; AREA UNDER CURVE; CEPHALOSPORINS; DRUG ADMINISTRATION SCHEDULE; DRUG DOSAGE CALCULATIONS; FEMALE; HALF-LIFE; HEALTHY VOLUNTEERS; HUMANS; JAPAN; MALE; MIDDLE AGED; SIDEROPHORES;

EID: 85042399309     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.02163-17     Document Type: Article

References (20)

1. Hoban DJ, Reinert RR, Bouchillon SK, Dowzicky MJ. 2015. Global in vitro activity of tigecycline and comparator agents: Tigecycline Evaluation and Surveillance Trial 2004-2013. Ann Clin Microbiol Antimicrob 14:27. https://doi.org/10.1186/s12941-015-0085-1.
2. Centers for Disease Control and Prevention. 2013. Antibiotic resistance threats in the United States, 2013. Centers for Disease Control and Prevention, Atlanta, GA. https://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf.
3. World Health Organization. 2017. Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. World Health Organization, Geneva, Switzerland. http://www.who.int/medicines/publications/global-priority-list-antibiotic-resistant-bacteria/en/.
4. Livermore DM. 2012. Current epidemiology and growing resistance of gram-negative pathogens. Korean J Intern Med 27:128–142. https://doi.org/10.3904/kjim.2012.27.2.128.
5. Tängdén T, Giske CG. 2015. Global dissemination of extensively drug-resistant carbapenemase-producing Enterobacteriaceae: clinical perspectives on detection, treatment and infection control. J Intern Med 277:501–512. https://doi.org/10.1111/joim.12342.
6. Castanheira M, Deshpande LM, Costello A, Davies TA, Jones RN. 2014. Epidemiology and carbapenem resistance mechanisms of carbapenem-non-susceptible Pseudomonas aeruginosa collected during 2009-11 in 14 European and Mediterranean countries. J Antimicrob Chemother 69: 1804 –1814. https://doi.org/10.1093/jac/dku048.
7. Evans BA, Amyes SG. 2014. OXA -lactamases. Clin Microbiol Rev 27: 241–263. https://doi.org/10.1128/CMR.00117-13.
8. Rumbo C, Gato E, López M, Ruiz de Alegría C, Fernández-Cuenca F, Martínez-Martínez L, Vila J, Pachón J, Cisneros JM, Rodríguez-Baño J, Pascual A, Bou G, Tomás M, Spanish Group of Nosocomial Infections and Mechanisms of Action and Resistance to Antimicrobials (GEIH-GEMARA), Spanish Society of Clinical Microbiology and Infectious Diseases (SEIMC), Spanish Network for Research in Infectious Diseases (REIPI). 2013. Contribution of efflux pumps, porins, and -lactamases to multidrug resistance in clinical isolates of Acineto-bacter baumannii. Antimicrob Agents Chemother 57:5247–5257. https://doi.org/10.1128/AAC.00730-13.
9. Ito A, Kohira N, Bouchillon SK, West J, Rittenhouse S, Sader HS, Rhomberg PR, Jones RN, Yoshizawa H, Nakamura R, Tsuji M, Yamano Y. 2016. In vitro antimicrobial activity of S-649266, a catechol-substituted siderophore cephalosporin, when tested against non-fermenting Gram-negative bacteria. J Antimicrob Chemother 71:670–677. https://doi.org/10.1093/jac/dkv402.
10. Kohira N, West J, Ito A, Ito-Horiyama T, Nakamura R, Sato T, Rittenhouse S, Tsuji M, Yamano Y. 2015. In vitro antimicrobial activity of a siderophore cephalosporin, S-649266, against Enterobacteriaceae clinical isolates, including carbapenem-resistant strains. Antimicrob Agents Chemother 60:729–734. https://doi.org/10.1128/AAC.01695-15.
11. Nakamura R, Toba S, Tsuji M, Yamano Y, Shimada J. 2014. A novel siderophore cephalosporin: IV. In vivo efficacy in various murine infection models, abstr F-1558. Abstr 54th Intersci Conf Antimicrob Agents Chemother, Washington, DC. American Society for Microbiology, Washington, DC.
12. Ito A, Nishikawa T, Matsumoto S, Yoshizawa H, Sato T, Nakamura R, Tsuji M, Yamano Y. 2016. Siderophore cephalosporin cefiderocol utilizes ferric iron transporter systems for antibacterial activity against Pseudomonas aeruginosa. Antimicrob Agents Chemother 60:7396–7401. https://doi.org/10.1128/AAC.01405-16.
13. Braun V, Pramanik A, Gwinner T, Köberle M, Bohn E. 2009. Sideromycins: tools and antibiotics. Biometals 22:3–13. https://doi.org/10.1007/s10534-008-9199-7.
14. Górska A, Sloderbach A, Marszałł MP. 2014. Siderophore-drug complexes: potential medicinal applications of the ‘Trojan horse’ strategy. Trends Pharmacol Sci 35:442–449. https://doi.org/10.1016/j.tips.2014.06.007.
15. U.S. National Library of Medicine, U.S. National Institutes of Health. 2017. ClinicalTrials.gov. Study of S-649266 or best available therapy for the treatment of severe infections caused by carbapenem-resistant Gram-negative pathogens (CREDIBLE-CR). U.S. National Library of Medicine, U.S. National Institutes of Health, Bethesda, MD. https://clinicaltrials.gov/t2/show/NCT02714595. Last updated 10 February 2017. Accessed 24 April 2017.
16. U.S. National Library of Medicine, U.S. National Institutes of Health. 2017. ClinicalTrials.gov. A study of efficacy/safety of intravenous S-649266 versus imipenem/cilastatin in complicated urinary tract infections (APEKS-cUTI). U.S. National Library of Medicine, U.S. National Institutes of Health, Bethesda, MD. https://clinicaltrials.gov/ct2/show/NCT02321800. Last updated 18 April 2017. Accessed 24 April 2017.
17. Katsube T, Echols R, Arjona Ferreira JC, Krenz HK, Berg JK, Galloway C. 2017. Cefiderocol, a siderophore cephalosporin for Gram-negative bacterial infections: pharmacokinetics and safety in subjects with renal impairment. J Clin Pharmacol 57:584–591. https://doi.org/10.1002/jcph.841.
18. Katsube T, Wajima T, Ishibashi T, Arjona Ferreira JC, Echols R. 2016. Pharmacokinetic/pharmacodynamic modeling and simulation of cefiderocol, a parenteral siderophore cephalosporin, for dose adjustment based on renal function. Antimicrob Agents Chemother 61:e01381 -16. https://doi.org/10.1128/AAC.01381-16.
19. U.S. Food and Drug Administration. 2001. Guidance: potassium iodide as a thyroid blocking agent in radiation emergencies. U.S. Food and Drug Administration, Rockville, MD. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM080542.pdf. Accessed Aril 26, 2017.
20. Hackel MA, Tsuji M, Yamano Y, Echols R, Karlowsky JA, Sahm DF. 2018. In vitro activity of the siderophore cephalosporin, cefiderocol, against carbapenem-nonsusceptible and multidrug-resistant isolates of Gram-negative bacilli collected worldwide in 2014 to 2016. Antimicrob Agents Chemother 62:e01968-17. https://doi.org/10.1128/AAC.01968-17.