A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections

Inclusion Criteria:

• Patients who are eligible for the study must have clinical evidence of cIAI

• Require surgical intervention (eg, laparotomy, laparoscopic surgery, or percutaneousdrainage) to manage the cIAI

• Require antibacterial therapy for 5 to 14 days in addition to the surgicalintervention

• Must, based on the judgment of the investigator, require hospitalization initially andantibacterial therapy for 5 to 14 days in addition to surgical intervention for thetreatment of the current cIAI. (Note that the patient must require at least 3 days ofIV antibiotic therapy initially)

• Have a signed informed consent form completed by the patient's parent or legalrepresentative (and a signed assent form obtained from patients who are capable ofproviding assent, typically, children 7 years of age and older)

Exclusion Criteria:

• Have a history of hypersensitivity reactions to carbapenems, cephalosporins,penicillins, or other beta-lactam antibiotics

• concomitant infection including but not limited to suspected or confirmed meningitisor central nervous system infection requiring systemic antibiotic or antifungaltherapy in addition to the iv study drug therapy at the time of randomization

• Receipt of nonstudy systemic antibiotic therapy for cIAI for more than 24 hoursimmediately preceding the start of the infusion of the first dose of iv study drugtherapy

• Have a diagnosis of abdominal wall abscess confined to musculature of the abdominalwall, small bowel obstruction or ischemic bowel disease without perforation, traumaticbowel perforation requiring surgery within 12 hours of perforation, or perforation ofgastroduodenal ulcers requiring surgery within 24 hours of perforation (these areconsidered situations of peritoneal soiling before the infection has becomeestablished)

• Have simple (noncomplicated), nonperforated appendicitis or gangrenous appendicitiswithout rupture into the peritoneal cavity identified during a surgical procedure ORpresence of spontaneous bacterial peritonitis or peritonitis associated with cirrhosisor chronic ascites

• Known at the time of randomization to have a cIAI caused by at least one pathogen thatis nonsusceptible to doripenem or meropenem

• Presence of any of the following clinically significant laboratory abnormalities:Hematocrit of less than 20%, absolute neutrophil count (ANC) <500 cells/µL, plateletcount <40,000 cells/µL, serum alanine aminotransferase or aspartate aminotransferase (AST) or total bilirubin 5 times or greater the age-specific upper limit of normal (ULN) or acute/chronic renal insufficiency with a baseline creatinine clearance <50 mLper minute or requires dialysis therapy for any reason

• Have a history of uncontrolled epilepsy defined as at least 1 seizure within the 6months before randomization