Safety and tolerability of ertapenem versus ceftriaxone in a double-blind study performed in children with complicated urinary tract infection, community-acquired pneumonia or skin and soft-tissue infection

International Journal of Antimicrobial Agents

Volumn 33, Issue 2, 2009, Pages 163-167

  Arguedas, Adriano ^a   Cespedes, Jaime ^b   Botet, Francesc Aseni ^c   Blumer, Jeffrey ^d   Yogev, Ram ^e   Gesser, Richard ^f   Wang, Jean ^f   West, Joseph ^f   Snyder, Theresa ^f   Wimmer, Wendy ^f  

^a Instituto de Atencion Pediatrica Costa Rica   (Costa Rica)

^b FUNDACIÓN CARDIOINFANTIL INSTITUTO DE CARDIOLOGÍA   (Colombia)

^c HOSPITAL INFANTIL LA FE   (Spain)

^d UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

^e CHILDREN'S MEMORIAL HOSPITAL   (United States)

^f MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Ertapenem; Paediatric; Pneumonia; Skin; Urinary tract infection

Indexed keywords

AMOXICILLIN PLUS CLAVULANIC ACID; CEFTRIAXONE; ERTAPENEM;

ADOLESCENT; ADULT; ANTIBIOTIC THERAPY; ARTICLE; CHILD; CLINICAL EVALUATION; CLINICAL TRIAL; COMMUNITY ACQUIRED PNEUMONIA; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ERYTHEMA; FEMALE; HUMAN; INFANT; INJECTION SITE PAIN; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SOFT TISSUE INFECTION; TREATMENT DURATION; TREATMENT OUTCOME; URINARY TRACT INFECTION; VOMITING;

EID: 58149204232     PISSN: 09248579     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijantimicag.2008.08.005     Document Type: Article

References (15)

1. Paterson D.L., Rossi F., Baquero F., Hsueh P.R., Woods G.L., Satishchandran V., et al. In vitro susceptibilities of aerobic and facultative Gram-negative bacilli isolated from patients with intraabdominal infections worldwide: the 2003 Study for Monitoring Antimicrobial Resistance Trends (SMART). J Antimicrob Chemother 55 (2005) 965-973
2. European Agency for the Evaluation of Medicinal Products. Committee for Proprietary Medicinal Products (CPMP). Note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections. CPMP/EWP/558/95 rev 1, 22 April 2004. http://www.emea.europa.eu/pdfs/human/ewp/055895en.pdf [accessed 17 March 2008].
3. Fuchs P.C., Barry A.L., and Brown S.D. In vitro activities of ertapenem (MK-0826) against clinical bacterial isolates from 11 North American medical centers. Antimicrob Agents Chemother 45 (2001) 1915-1918
4. Hilliard N.J., Johnson C.N., Armstrong S.H., Quarles S., and Waites K.B. In vitro activity of ertapenem (MK-0826) against multi-drug resistant Streptococcus pneumoniae compared with 13 other antimicrobials. Int J Antimicrob Agents 20 (2002) 136-140
5. Bishara J., Livne G., Ashkenazi S., Levy I., Pitlik S., Ofir O., et al. Antibacterial susceptibility of extended-spectrum beta-lactamase-producing Klebsiella pneumoniae and Escherichia coli. Isr Med Assoc J 7 (2005) 298-301
6. Lipsky B.A., Armstrong D.G., Citron D.M., Tice A.D., Morgenstern D.E., and Abramson M.A. Ertapenem versus piperacillin/tazobactam for diabetic foot infections (SIDESTEP): prospective, randomised, controlled, double-blinded, multicentre trial. Lancet 366 (2005) 1695-1703
7. Majumdar A.K., Musson D.G., Birk K.L., Kitchen C.J., Holland S., McCrea J., et al. Pharmacokinetics of ertapenem in healthy young volunteers. Antimicrob Agents Chemother 46 (2002) 3506-3511
8. Itani K.M., Wilson S.E., Awad S.S., Jensen E.H., Finn T.S., and Abramson M.A. Ertapenem versus cefotetan prophylaxis in elective colorectal surgery. N Engl J Med 355 (2006) 2640-2651
9. Yellin A.E., Johnson J., Higareda I., Congeni B.L., Arrieta A.C., Fernsler D., et al. Ertapenem or ticarcillin/clavulanate for treatment of intra-abdominal infections or acute pelvic infections in pediatric patients. Am J Surg 194 (2007) 367-374
10. Gesser R.M., McCarroll K., Teppler H., and Woods G.L. Efficacy of ertapenem in the treatment of serious infections caused by Enterobacteriaceae: analysis of pooled clinical trial data. J Antimicrob Chemother 51 (2003) 1253-1260
11. Graham D.R., Lucasti C., Malafaia O., Nichols R.L., Holtom P., Perez N.Q., et al. Ertapenem once daily versus piperacillin-tazobactam 4 times per day for treatment of complicated skin and skin-structure infections in adults: results of a prospective, randomized, double-blind multicenter study. Clin Infect Dis 34 (2002) 1460-1468
12. Ortiz-Ruiz G., Vetter N., Isaacs R., Carides A., Woods G.L., and Friedland I. Ertapenem versus ceftriaxone for the treatment of community-acquired pneumonia in adults: combined analysis of two multicentre randomized, double-blind studies. J Antimicrob Chemother 53 Suppl. 2 (2004) ii59-66
13. Vetter N., Cambronero-Hernandez E., Rohlf J., Simon S., Carides A., Oliveria T., et al., Protocol 020 Study Group. A prospective, randomized, double-blind multicenter comparison of parenteral ertapenem and ceftriaxone for the treatment of hospitalized adults with community-acquired pneumonia. Clin Ther 24 (2002) 1770-1785
14. Wells W.G., Woods G.L., Jiang Q., and Gesser R.M. Treatment of complicated urinary tract infection in adults: combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy. J Antimicrob Chemother 53 Suppl. 2 (2004) ii67-74
15. Tomera K.M., Burdmann E.A., Reyna O.G., Jiang Q., Wimmer W.M., Woods G.L., et al., Protocol 014 Study Group. Ertapenem versus ceftriaxone followed by appropriate oral therapy for treatment of complicated urinary tract infections in adults: results of a prospective, randomized, double-blind multicenter study. Antimicrob Agents Chemother 46 (2002) 2895-2900