A Study of Doripenem in CerebrospinalFluid After Doripenem Administration in Pediatric Patients Less Than 1 Year of Age

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to characterize the penetration of doripenem in the cerebral spinal fluid in pediatric patients <1 year of age who are hospitalized and have a documented or suspected infection and are planning to, or undergoing treatment with intravenous (IV) antibiotics.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Doripenem

Criteria

Inclusion Criteria:

• Patient is expected to require hospitalization for the entire open-label phase of the study.

• Patient must be scheduled to have cerebral spinal fluid obtained via a lumbar puncture (referred to as a "spinal tap") or ventriculoperitoneal (VP) shunt tap within 3 days of enrollment into this study.

• Patient must have documented or suspected infection and is planning to, or undergoing treatment with IV antibiotics.

• Parent or the patient's legally acceptable representative must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to allow the infant to participate in the study.

Exclusion Criteria:

• Clinically significant abnormal values for hematology or clinical chemistry at screening that, at the option of the investigator, are not consistent with the patient's underlying disease(s) or therapies.

• Any condition at screening that, in the opinion of the investigator, may interfere with the assessments of this study.

• Patients with substantially compromised renal (kidney) function: e.g., urine output is <0.25cc/kg/hr within the 24 hours before screening.

• History of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other Beta-lactam antibiotics.

• Known allergy to heparin or history of heparin-induced thrombocytopenia, if an in-dwelling cannula (e.g., heparin lock) or central line is used.

• Patients concomitantly treated with or having received imipenem/cilastin within 48 hours before study drug administration.

• Patients concomitantly treated with probenecid or valproic acid (VPA).