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

• Conditions: Complicated Intra-Abdominal Infections; MedDRA version: 14.0Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2009-015864-32-Outside-EU/EEA
• Lead Sponsor: Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1 - Subject randomly assigned to treatment postoperatively or intra-operatively after visual confirmation of established cIAI (presence of pus within the abdominal cavity) including the following eligible diagnoses:
– appendicitis complicated by rupture and/or abscess
– traumatic perforation of the intestines, which are being operated on more than 12 hours after perforation occurred
– acute gastric, duodenal, or gall bladder perforations, which are being operated on more than 24 hours after perforation occurred
– secondary peritonitis due to perforated viscus, postoperative or other focus of infection. (Subjects with inflammatory bowel disease or ischemic bowel disease are eligible to enroll provided there is bowel perforation)
– intra-abdominal bacterial abscess (including liver)
OR
Subject randomly assigned to treatment pre-operatively and has pre-operative clinical evidence of cIAI including all of the following:
– Evidence of systemic inflammatory response as demonstrated by at least one of the following:
? Fever (oral temperature >38.0C, tympanic temperature >38.3C, or rectal or core temperature >38.8C) or hypothermia (rectal or core temperature <35.0C)
? Have leukocytosis (WBC count =15,000 cells/µL OR =15% immature neutrophils , regardless of the total peripheral white cell count)
? Hypotension defined by the following:
o For children greater than 1 year of age: Systolic blood pressure =70 mm Hg + (2 multiplied by age [in years])
o For children aged 3 months to =1 year: Systolic blood pressure =70 mm Hg
AND
– At least one of the following physical signs consistent with cIAI:
o Abdominal pain or tenderness
o Localized or diffused abdominal wall rigidity
o Presence of abdominal mass
o Ileus
AND
– Supportive radiologic findings in the abdomen such as intraperitoneal abscess detected on computer tomography scan films or an ultrasound;
2 - Must have a requirement for surgical intervention (eg, laparotomy, laparoscopic surgery, or percutaneous drainage) to manage the cIAI within the 24 hours before to within the 24 hours after randomization;
3 - 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 subject must require at least 3 days of IV antibiotic therapy initially).
Are the trial subjects under 18? yes
Number of subjects for this age range: 140
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1 - Have a history of hypersensitivity reactions to carbapenems, cephalosporins, penicillins, or other ß-lactam antibiotics. Note: Subjects with a history of mild non urticarial skin rash temporally related to but considered not associated with the previous use of ß-lactam antibiotics are permitted to enroll in the study. For such subjects, there must be a description of the rash and documentation by the investigator that upon review of the history it is his/her opinion that the rash was unlikely due to any of the above-mentioned classes of drugs for the subject to qualify for inclusion in the study;
2 - Concomitant infection including but not limited to suspected or confirmed meningitis or other CNS infection requiring systemic antibiotic or antifungal therapy at the time of randomization. (Clarification: possible bacteremia with a presumed intra abdominal pathogen is acceptable);
3 - Have received more than 24 hours of systemic antibiotic therapy immediately preceding the start of the infusion of the first dose of IV study drug therapy
4 - Girls who are pregnant or are nursing a child or are menarchal, and if sexually active are not practicing a highly effective method of birth control (eg, prescription hormonal contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream or gel, male partner sterilization) as local regulations permit, before screening and do not agree to continue using a highly effective method of birth control (as previously described) for 30 days after administration of the last dose of study drug therapy. Note: for all menarchal girls, confirm a negative urine or serum pregnancy test (ß-human chorionic gonadotropin [ß-hCG]) at screening, before enrolling the subject into the study;
5 - Have a history of uncontrolled epilepsy defined as at least 1 seizure within the 6 months before randomization.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified