| Abstract | 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. |
| Authors | Albert E Yellin, Jeffrey Johnson, Iliana Higareda, Blaise L Congeni, Antonio C Arrieta, Doreen Fernsler, Joseph West, Richard Gesser
(Affiliation: 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 at surgery.usc.edu)
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| Journal | American journal of surgery
(Am J Surg)
Vol. 194
Issue 3
Pg. 367-74
(Sep 2007)
ISSN: 0002-9610 United States |
| PMID | 17693284
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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| Chemical References |
- Anti-Bacterial Agents
- Clavulanic Acids
- beta-Lactams
- ertapenem
- Ticarcillin
- ticarcillin-clavulanic acid
|
| Topics |
- Abdominal Cavity
- Acute Disease
- Adolescent
- Anti-Bacterial Agents
(therapeutic use)
- Bacterial Infections
(drug therapy)
- Child
- Child, Preschool
- Clavulanic Acids
(therapeutic use)
- Female
- Humans
- Male
- Pelvis
- Prospective Studies
- Ticarcillin
(therapeutic use)
- beta-Lactams
(therapeutic use)
|
