Ertapenem or ticarcillin/clavulanate for the treatment of intra-abdominal infections or acute pelvic infections in pediatric patients.
BACKGROUND
Ertapenem, a group I carbapenem antibiotic, has been shown to be safe and effective in treating adults with complicated intra-abdominal (cIAI) or acute pelvic infection (API). This study evaluated ertapenem for treating these infections in children.


METHODS
In an open-label study, children aged 2 to 17 years with cIAI or API were randomized 3:1 to receive ertapenem or ticarcillin/clavulanate. Children 13 to 17 years of age received 1 g parenterally daily, and those 2 to 12 years of age received 15 mg/kg twice daily. Patients < 60 kg received ticarcillin/clavulanate 50 mg/kg 4 to 6 times daily and 3.1 g 4 to 6 times daily for those > or = 60 kg. Patients were assessed for safety and tolerability throughout the study and for efficacy after the completion of therapy.


RESULTS
One hundred five patients, 72 (69%) with cIAI, received > or = 1 dose of study drug and were included in the safety analysis. Eighty-one patients were treated with ertapenem. Infusion site pain was the most common drug-related adverse event in both groups. In the modified intent-to-treat analysis, the age-adjusted posttreatment clinical response rates were 87% (43/50 patients) and 100% (25/25 patients) in the cIAI and API patients, respectively, for ertapenem and 73% (11/15 evaluable patients) and 100% (8/8 evaluable patients), respectively, for ticarcillin/clavulanate. Overall age-adjusted response rates were 91% (68/75 evaluable patients) for ertapenem and 83% (19/23 evaluable patients) for the comparator.


CONCLUSIONS
This study suggests that ertapenem is generally safe and efficacious for treating cIAI or API in pediatric patients.
Yellin
Albert E
AE
Department of Surgery, Keck School of Medicine of the University of Southern California, 1200 N State St, Rm 9610, Los Angeles, CA 90033, USA. ayellin@surgery.usc.edu
Johnson
Jeffrey
J
Higareda
Iliana
I
Congeni
Blaise L
BL
Arrieta
Antonio C
AC
Fernsler
Doreen
D
West
Joseph
J
Gesser
Richard
R
D034841:Abdominal Cavity; D000208:Acute Disease; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D002969:Clavulanic Acids / Q000627:therapeutic use; D000077727:Ertapenem; D005260:Female; D006801:Humans; D008297:Male; D010388:Pelvis; D011446:Prospective Studies; D013982:Ticarcillin / Q000627:therapeutic use; D047090:beta-Lactams / Q000627:therapeutic use*
D000900:Anti-Bacterial Agents; D002969:Clavulanic Acids; D047090:beta-Lactams; C043215:ticarcillin-clavulanic acid; D013982:Ticarcillin; D000077727:Ertapenem