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

Completed · Phase 1

Conditions studied: Bacterial Infections

In brief

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.

Key facts

Study ID

NCT01381848

Run by

Janssen Research & Development, LLC

People needed

52

Starts

2009-10-01

Expected to finish

2012-04-01

Last updated by the study team

2013-01-10

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Orange, California, United States
• Study site — Royal Oak, Michigan, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Toledo, Ohio, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Leuven, Belgium
• Study site — Chertsey, United Kingdom
• Study site — Exeter, United Kingdom
• Study site — Liverpool, United Kingdom
• Study site — Manchester, United Kingdom
• Study site — Norwich, United Kingdom

Full record on ClinicalTrials.gov

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