PMID- 18945594
OWN - NLM
STAT- MEDLINE
DCOM- 20090310
LR  - 20220408
IS  - 0924-8579 (Print)
IS  - 0924-8579 (Linking)
VI  - 33
IP  - 2
DP  - 2009 Feb
TI  - 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.
PG  - 163-7
LID - 10.1016/j.ijantimicag.2008.08.005 [doi]
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.
FAU - Arguedas, Adriano
AU  - Arguedas A
AD  - Instituto de Atencion Pediatrica, Universidad de Ciencias Medicas, Instituto 
      Costarricense de Investigaciones Clinicas, San Jose, Costa Rica. 
      aarguedas@iped.net
FAU - Cespedes, Jaime
AU  - Cespedes J
FAU - Botet, Francesc Aseni
AU  - Botet FA
FAU - Blumer, Jeffrey
AU  - Blumer J
FAU - Yogev, Ram
AU  - Yogev R
FAU - Gesser, Richard
AU  - Gesser R
FAU - Wang, Jean
AU  - Wang J
FAU - West, Joseph
AU  - West J
FAU - Snyder, Theresa
AU  - Snyder T
FAU - Wimmer, Wendy
AU  - Wimmer W
CN  - Protocol 036 Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT00451386
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20081021
PL  - Netherlands
TA  - Int J Antimicrob Agents
JT  - International journal of antimicrobial agents
JID - 9111860
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (beta-Lactams)
RN  - 75J73V1629 (Ceftriaxone)
RN  - G32F6EID2H (Ertapenem)
SB  - IM
MH  - Adolescent
MH  - Anti-Bacterial Agents/*adverse effects/therapeutic use
MH  - Ceftriaxone/*adverse effects/therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Community-Acquired Infections
MH  - Double-Blind Method
MH  - Ertapenem
MH  - Female
MH  - Humans
MH  - Infant
MH  - Male
MH  - Molecular Sequence Data
MH  - Pneumonia, Bacterial/*drug therapy
MH  - Skin Diseases, Bacterial/*drug therapy
MH  - Soft Tissue Infections/*drug therapy
MH  - Urinary Tract Infections/*drug therapy
MH  - beta-Lactams/*adverse effects/therapeutic use
FIR - Ardila, Margarita
IR  - Ardila M
FIR - Arrieta, Antonio
IR  - Arrieta A
FIR - Azimi, Parvin
IR  - Azimi P
FIR - Bradley, John
IR  - Bradley J
FIR - Chatterjee, Archana
IR  - Chatterjee A
FIR - Cizman, Milan
IR  - Cizman M
FIR - Clark, William
IR  - Clark W
FIR - Domachowske, Joseph
IR  - Domachowske J
FIR - Galaz, Maria Isabel
IR  - Galaz MI
FIR - Garces, Raquel
IR  - Garces R
FIR - de Miguel, Maria Garcia
IR  - de Miguel MG
FIR - Georgescu, Andrian
IR  - Georgescu A
FIR - Hahn, Deidre
IR  - Hahn D
FIR - Heystek, Martinus
IR  - Heystek M
FIR - Koh, Mia
IR  - Koh M
FIR - La Via, William
IR  - La Via W
FIR - Ledermann, Walter
IR  - Ledermann W
FIR - Lieberman, Jay
IR  - Lieberman J
FIR - Mani, Chitra
IR  - Mani C
FIR - Reigada, Carmen Otero
IR  - Reigada CO
FIR - Rodrigues, Ana
IR  - Rodrigues A
FIR - Rodriguez, Adib
IR  - Rodriguez A
FIR - Rowen, Judith
IR  - Rowen J
FIR - Rudoy, Raul
IR  - Rudoy R
FIR - Ruiz-Contreras, Jesus
IR  - Ruiz-Contreras J
FIR - SanJoaquin, Venusto
IR  - SanJoaquin V
FIR - Segura, Libia
IR  - Segura L
FIR - Stein, Renato
IR  - Stein R
FIR - Suarez, Jose
IR  - Suarez J
FIR - Tamarit, Desamparados Perez
IR  - Tamarit DP
FIR - Tan, Kah
IR  - Tan K
FIR - Thurmann, Petra
IR  - Thurmann P
FIR - Van Dyk, Jacobus
IR  - Van Dyk J
FIR - Velasco-Bernardo, Rosa
IR  - Velasco-Bernardo R
FIR - Yap, Hui Kim
IR  - Yap HK
FIR - Zielen, Stefan
IR  - Zielen S
EDAT- 2008/10/24 09:00
MHDA- 2009/03/11 09:00
CRDT- 2008/10/24 09:00
PHST- 2008/03/27 00:00 [received]
PHST- 2008/07/24 00:00 [revised]
PHST- 2008/08/01 00:00 [accepted]
PHST- 2008/10/24 09:00 [pubmed]
PHST- 2009/03/11 09:00 [medline]
PHST- 2008/10/24 09:00 [entrez]
AID - S0924-8579(08)00383-X [pii]
AID - 10.1016/j.ijantimicag.2008.08.005 [doi]
PST - ppublish
SO  - Int J Antimicrob Agents. 2009 Feb;33(2):163-7. doi: 
      10.1016/j.ijantimicag.2008.08.005. Epub 2008 Oct 21.