Single-dose pharmacokinetics and safety of a novel broad-spectrum cephalosporin (BAL5788) in healthy volunteers

Antimicrobial Agents and Chemotherapy

Volumn 48, Issue 7, 2004, Pages 2570-2575

  Schmitt Hoffmann, Anne ^a   Roos, Brigitte ^a   Schleimer, Michael ^a   Sauer, Jill ^a   Man, Anthony ^a   Nashed, Norman ^a   Brown, Thomas ^a   Perez, Antonio ^a   Weidekamm, Erhard ^a   Kovács, Péter ^b  

^a BASILEA PHARMACEUTICA INTERNATIONAL LTD   (Switzerland)

^b UNIVERSITY OF DEBRECEN   (Hungary)

Author keywords

[No Author keywords available]

Indexed keywords

CEFTOBIPROLE; CEFTOBIPROLE MEDOCARIL; CEPHALOSPORIN DERIVATIVE; PLACEBO; PRODRUG; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; BACTERICIDAL ACTIVITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG EXCRETION; DRUG HALF LIFE; DRUG SAFETY; DRUG STRUCTURE; ELECTROCARDIOGRAPHY; EXTRACELLULAR SPACE; GLOMERULUS FILTRATION RATE; HUMAN; HUMAN EXPERIMENT; KIDNEY CLEARANCE; MALE; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; NAUSEA; NORMAL HUMAN; PHARMACOKINETICS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STAPHYLOCOCCUS INFECTION; STEADY STATE; STREPTOCOCCUS PNEUMONIAE; TASTE DISORDER; VOMITING;

ADULT; AREA UNDER CURVE; CEPHALOSPORINS; CHROMATOGRAPHY, LIQUID; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; HALF-LIFE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MASS SPECTROMETRY;

EID: 3042621802     PISSN: 00664804     EISSN: None     Source Type: Journal    
DOI: 10.1128/AAC.48.7.2570-2575.2004     Document Type: Article

References (23)

1. Alexander, J., D. S. Bindra, J. D. Glass, M. A. Holahan, M. L. Renyer, G. S. Rork, et al. 1996. Investigation of (oxodioxolenyl)methyl carbamates as non-chiral bioreversible prodrug moieties for chiral amines. J. Med. Chem. 39:480-486.
2. Cars, O. 1997. Efficacy of beta-lactam antibiotics: integration of pharmacokinetics and pharmacodynamics. Diagn. Microbiol. Infect. Dis. 27:29-33.
3. Chew, T. A., and J. M. Smith. 1992. Detection of diacetyl (caramel odor) in presumptive identification of the "Streptococcus milleri" group. J. Clin. Microbiol. 30:3028-3029.
4. Craig, W. A. 2001. Does the dose matter? Clin. Infect. Dis. 33(Suppl. 2): 233-237.
5. Dancer, S. J. 2001. The problem with cephalosporins. J. Antimicrob. Chemother. 48:463-478.
6. Daum, S., and J. B. Seal 2001. Evolving antimicrobial; chemotherapy for Staphylococcus aureus infections: our backs to the wall. Crit. Care Med. 29(4 Suppl.):N92-N96.
7. Diekema, D. J., M. A. Pfaller, F. J. Schmitz, J. Smayevski, J. Bell, R. N. Jones, and M. Beach. 2001. Survey of infections due to Staphylococcus species: frequency of occurrence and antimicrobial susceptibility of isolates collected in the United States, Europe, and the Western Pacific Region for the SENTRY antimicrobial surveillance program, 1997-1999. Clin. Infect. Dis. 32(Suppl. 2): S114-S132.
8. Entenza, J. M., P. Hohl, I. Heinze-Krauss, M. P. Glauser, and P. Moreillon. 2002. BAL9141, a novel extended-spectrum cephalosporin active against methicillin-resistant Staphylococcus aureus in treatment of experimental endocarditis. Antimicob. Agents Chemother. 46:171-177.
9. Fuchs, P. C., A. L. Barry, and S. D. Brown. 2000. Bactericidal activity of quinupristin-dalfopristin against Staphylococcus aureus: clindamycin susceptibility as a surrogate indicator. Antimicrob. Agents Chemother. 44:2880-2882.
10. Glinka, T. W. 2002. Novel cephalosporins for the treatment of MRSA infections. Curr. Opin. Investig. Drugs 3:206-217.
11. Haley, R. W., A. W. Hightower, R. F. Khabbaz, C. Thornsberry, W. J. Martone, J. R. Allen, and J. M. Hughes. 1982. The emergence of methicillin-resistant Staphylococcus aureus infections in United States hospitals: possible role of the house staff-patient transfer circuit. Ann. Intern. Med. 97:297-308.
12. Hebeisen, P., I. Heinze-Krauss, P. Angehrn, P. Hohl, M. G. P. Page, and R. L. Then. 2001. In vitro and in vivo properties of Ro 63-1941, a novel broad-spectrum cephalosporin with activity against methicillin-resistant staphylococci. Antimicrob. Agents Chemother. 45:825-836.
13. Jones, R. N., L. M. Deshpande, A. H. Mutnick, and D. J. Biedenbach. 2002. In vitro evaluation of BAL9141, a novel parenteral cephalosporin active against oxacillin-resistant staphylococci. J. Antimicrob. Ther. 50:915-932.
14. Klepser, M. E., M. N. Marangos, K. B. Patel, D. P. Nicolau, R. Quintiliani, and C. H. Nightingale. 1995. Clinical pharmacokinetics of newer cephalosporins. Clin. Pharmacokinet. 28:361-384.
15. Mouton, J. W., and N. Punt. 2001. Use of the t>MIC to choose between different dosing regimens of beta-lactam antibiotics. J. Antimicrob. Chemother. 47:500-501.
16. Nix, D., S. Goodwin, C. Peloquin, D. Rotella, and J. Schentag. 1991. Antibiotic tissue distribution and its relevance: models of tissue penetration and their meaning. Antimicrob. Agents Chemother. 35:1947-1952.
17. National Nosocomial Infections Surveillance System. 2001. NNIS special article. National Nosocomial Infections Surveillance System Report, data summary from January 1992-June 2001, issued August 2001. Am. J. Infect. Control 29:404-421.
18. Panlilio, A. L., D. H. Culver, R. P. Gaynes, S. Banerjee, T. S. Henderson, J. S. Tolson, and W. J. Martone. 1992. Methicillin-resistant Staphylococcus aureus in US hospitals, 1975-1991. Infect. Control Hosp. Epidemiol. 13:582-586.
19. Rogerson, F. S., H. Castro, N. Fortunato, Z. Azevedo, A. Macedo, and V. A. De Freitas. 2001. Chemicals with sweet aroma descriptors found in Portuguese wines from the Douro region: 2,6,6-trimethylcyclohex-2-ene-1,4-dione and diacetyl. J. Agric. Food Chem. 49:263-269.
20. Rybak, M. J., and R. L. Akins. 2001. Emergence of methicillin-resistant Staphylococcus aureus with intermediate glycopeptide resistance. Drugs 61:1-7.
21. Sievert, D. M., M. L. Boulton, G. Stoltman, D. Johnson, M. G. Stobierski, F. P. Downes, P. A. Somsel, J. T. Rudrik, W. Brown, W. Hafeez, T. Lundstrom, E. Flanagan, R. Johnson, J. Mitchell, and S. Chang. 2002. Staphylococcus aureus resistant to vancomycin-United States, 2002. Morb. Mortal. Wkly. Rep. 51:565-567.
22. Sörgel, F., and M. Kinzig. 1993. The chemistry, pharmacokinetics and tissue distribution of piperazillin/tazobactam. J. Antimicrob. Chemother. 31:39-60.
23. Tsiodras, S., H. S. Gold, G. Sakoulas, G. M. Eliopoulos, C. Wennersten, L. Venkataraman, R. C. Moellering, and M. J. Ferraro. 2001. Linezolid resistance in a clinical isolate of Staphylococcus aureus. Lancet 358:207-208.