A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized Wit… (NCT01110382) | Clinical Trial Compass
TerminatedPhase 3
A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections
Stopped: Trial terminated early per business decision
United States, Argentina41 participantsStarted 2010-12
Plain-language summary
The purpose of the study is to evaluate the safety and tolerability of doripenem compared with meropenem in children hospitalized with complicated intra-abdominal infections.
Who can participate
Age range3 Months – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are eligible for the study must have clinical evidence of cIAI
* Require surgical intervention (eg, laparotomy, laparoscopic surgery, or percutaneous drainage) to manage the cIAI
* Require antibacterial therapy for 5 to 14 days in addition to the surgical intervention
* Must, based on the judgment of the investigator, require hospitalization initially and antibacterial therapy for 5 to 14 days in addition to surgical intervention for the treatment of the current cIAI. (Note that the patient must require at least 3 days of IV antibiotic therapy initially)
* Have a signed informed consent form completed by the patient's parent or legal representative (and a signed assent form obtained from patients who are capable of providing 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 meningitis or central nervous system infection requiring systemic antibiotic or antifungal therapy 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 hours immediately preceding the start of the infusion of the first dose of iv study drug therapy
* Have a diagnosis of abdominal wall abscess confined to musculature of the abdominal wall, small bowel obstru…
What they're measuring
1
The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit
Timeframe: TOC (7 to 14 days after the last dose of study medication therapy)