A Study of Doripenem in Infants Less Than 12 Weeks of Age

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to measure drug levels of doripenem in blood samples collected before and after administration of doripenem to infants less than 12 weeks of age who are hospitalized and documented, presumed to have, or are at risk for bacterial infection (s) and are undergoing treatment with intravenous (i.v.) antibiotics. Safety and tolerability will also be assessed.

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

Details

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

Criteria

Inclusion Criteria:

• Must be hospitalized, medically stable, without acute decline in physical condition in the inestigator's judgement

• Documented, presumed to have, or are at risk for bacterial infection(s) and are undergoing treatment with i.v. antibiotics

• Patient's weight (kg) must be within the 5th and the 95th percentile inclusive for his or her age

• 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 as deemed appropriate by the investigator

• Clinically significant abnormal physical examination or vital signs at screening, as deemed appropriate by the investigator

• Patients who, in the investigator's judgment, have compromised renal (kidney) function including renal failure

• 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 indwelling 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