TY - JOUR
T1 - 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
AU - Arguedas, Adriano
AU - Cespedes, Jaime
AU - Botet, Francesc Aseni
AU - Blumer, Jeffrey
AU - Yogev, Ram
AU - Gesser, Richard
AU - Wang, Jean
AU - West, Joseph
AU - Snyder, Theresa
AU - Wimmer, Wendy
N1 - Funding Information:
Competing interests : RG, JWa, JWe, TS and WW are all employees of Merck & Co., Inc., and potentially own stock and/or have equity interest in the company. All other authors report receiving consulting fees from Merck & Co., Inc. JC receives investigator fees as part of the Protocol 036 Study Group and declares no other competing interests. JB reports grant and research support from Astra Zeneca, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Pfizer, sanofi-aventis and Wyeth; consulting fees from Abbott, AstraZeneca, Bristol-Myers Squibb, Cubist, GlaxoSmithKline, MedImmune, Merck, Pfizer, Roche, sanofi-aventis and Sepracor; Speaker’s Bureau activity with Bristol-Myers Squibb, GlaxoSmithKline, Pfizer, Roche and Wyeth. All other authors report no competing interests.
Funding Information:
Funding : This trial was supported by Merck & Co., Inc., USA.
Funding Information:
Disclosure : Dr. Blummer: JB Jeffrey Blummer reports grant and research support from Astra Zeneca, Bristol-Meyers Squibb, GlaxoSmithKline, Merck, Pfizer, Sanofi-Aventis, and Wyeth; Consulting fees from: Abbott, AstraZeneca, Bristol Myers Squibb, Cubist, Glaxo Smith Kline, Medimmune, Merck, Pfizer, Roche, Sanofi-Aventis, Sepracor; SPEAKER’S BUREAU activity with: Bristol-Myers Squibb, Glaxo-SmithKline,Pfizer, Roche, and Wyeth.
PY - 2009/2
Y1 - 2009/2
N2 - The carbapenem antibiotic ertapenem has been shown to be safe, well tolerated and effective in treating adults with complicated urinary tract infection, skin and soft-tissue infection and community-acquired pneumonia. In this study, we evaluated ertapenem for treating these infections in children in a randomised, double-blind, active-controlled clinical trial. The primary outcome was the incidence of clinical and laboratory drug-related serious adverse events (AEs). Children were randomised in a 3:1 ratio (ertapenem:ceftriaxone) stratified by index infection and age to receive ertapenem or ceftriaxone; 303 children received ertapenem and 100 children received ceftriaxone. The median duration of parenteral therapy was 4 days for both treatments. The most commonly reported drug-related clinical AEs during parenteral therapy were diarrhoea (5.9% ertapenem, 10% ceftriaxone), infusion site erythema (3% ertapenem, 2% ceftriaxone) and infusion site pain (5% ertapenem, 1% ceftriaxone). One child in each group reported a serious drug-related clinical AE. No serious drug-related laboratory AEs were reported. In children aged 3 months to 17 years, ertapenem was well tolerated and had a comparable safety profile to that of ceftriaxone.
AB - The carbapenem antibiotic ertapenem has been shown to be safe, well tolerated and effective in treating adults with complicated urinary tract infection, skin and soft-tissue infection and community-acquired pneumonia. In this study, we evaluated ertapenem for treating these infections in children in a randomised, double-blind, active-controlled clinical trial. The primary outcome was the incidence of clinical and laboratory drug-related serious adverse events (AEs). Children were randomised in a 3:1 ratio (ertapenem:ceftriaxone) stratified by index infection and age to receive ertapenem or ceftriaxone; 303 children received ertapenem and 100 children received ceftriaxone. The median duration of parenteral therapy was 4 days for both treatments. The most commonly reported drug-related clinical AEs during parenteral therapy were diarrhoea (5.9% ertapenem, 10% ceftriaxone), infusion site erythema (3% ertapenem, 2% ceftriaxone) and infusion site pain (5% ertapenem, 1% ceftriaxone). One child in each group reported a serious drug-related clinical AE. No serious drug-related laboratory AEs were reported. In children aged 3 months to 17 years, ertapenem was well tolerated and had a comparable safety profile to that of ceftriaxone.
KW - Ertapenem
KW - Paediatric
KW - Pneumonia
KW - Skin
KW - Urinary tract infection
UR - http://www.scopus.com/inward/record.url?scp=58149204232&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=58149204232&partnerID=8YFLogxK
U2 - 10.1016/j.ijantimicag.2008.08.005
DO - 10.1016/j.ijantimicag.2008.08.005
M3 - Article
C2 - 18945594
AN - SCOPUS:58149204232
VL - 33
SP - 163
EP - 167
JO - International Journal of Antimicrobial Agents
JF - International Journal of Antimicrobial Agents
SN - 0924-8579
IS - 2
ER -