AN OPEN-LABEL STUDY TO EVALUATE THE SINGLE-DOSE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF DORIPENEM IN INFANTS (TERM AND PRETERM), LESS THAN 12 WEEKS CHRONOLOGICAL AGE

AN OPEN-LABEL STUDY TO EVALUATE THE SINGLE-DOSE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF DORIPENEM IN INFANTS (TERM AND PRETERM), LESS THAN 12 WEEKS CHRONOLOGICAL AGE

Approval Date: 12/31/1969

Principal Investigator: Graham Krasan, M.D.

The goal of this study is to evaluate the effects of the investigational drug, Doripenem on the blood and urine levels of infants who already require IV antibiotics. This study is also being done to determine the safety of the drug. This drug is investigational in children though it is approved in the United States by the Food and Drug Administration for treatment of some infections in adults.

Eligibility:

"Each study has its own guidelines for who can participate, called 'eligibility criteria.' Below is a partial list of criteria for acceptance into the research study. Only the study doctor can make the determination that you meet all eligibility criteria."

• Infant less than 12 weeks of CA
• Medically stable without acute decline in physical condition in the investigator's judgment.
• Signed informed consent
• Documented, presumed to have or are at risk for bacterial infections(s) and are on IV antibiotics treatment.
• Patient's weight (kg) must be within the 5^th and 95^th percentile inclusive for his or her age

Contact Person:
Jeni DeRidder, RN, BSN
248-898-4578

Beth Kring, RN, BSN
248-898-4578

Status of Clinical Trial:
open and enrolling