Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections

Completed · Phase 1/Phase 2

Conditions studied: Necrotizing Enterocolitis, Intra-abdominal Infection

In brief

Meropenem is an antibiotic that is commonly used to treat serious infections. Although it is used in premature and young infants, the correct dose is not known. The purpose of this study is to determine the correct dose and the safety of meropenem for the treatment of complicated intra-abdominal infections in these young babies.

Key facts

Study ID

NCT00621192

Run by

The Emmes Company, LLC

People needed

200

Starts

2008-06-01

Expected to finish

2009-10-01

Last updated by the study team

2023-04-25

Who can join

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

You may qualify if…

• Written permission from parent or legal guardian
• Age younger than 91 days
• Likely to survive beyond the first 48 hours after enrollment
• Sufficient intravascular access (either peripheral or central) to receive study drug.
• AND ONE OF THE FOLLOWING
• 1) Physical, radiological, and/or bacteriological findings of a complicated intra-abdominal infection. These include peritonitis, NEC (Necrotizing Enterocolitis) Grade II or higher by Bell's criteria, Hirschsprung's disease with perforation, spontaneous perforation, meconium ileus with perforation, bowel obstruction with perforation, as evidenced by free peritoneal air on abdominal radiograph, intestinal pneumatosis or portal venous gas on abdominal radiographic examination.
• OR 2) Possible NEC OR 3) Otherwise receiving meropenem per local standard of care

You may not qualify if…

• Renal dysfunction evidenced by urine output <0.5 mL/hr/kg over the prior 24 hours
• Serum creatinine >1.7 mg/dL
• History of clinical seizures or EEG (Electroencephalogram) confirmed seizures
• Concomitant treatment with another carbapenem (ertapenem or imipenem) at the time of informed consent
• Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Children's Hospital of Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• University of California Medical Center — San Diego, California, United States
• Sharp-Mary Birch Hospital for Women — San Diego, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
• Evanston Northwestern Healthcare — Evanston, Illinois, United States
• Indiana University - Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Kansas City Children's Mercy Hospital — Kansas City, Missouri, United States
• Albany Medical Center — Albany, New York, United States
• Suny Downstate Medical Center — Brooklyn, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Case Western Reserve, RB&C, UHCMC — Cleveland, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Magee Women's Hospital — Pittsburgh, Pennsylvania, United States
• Vanderbilt Children's Hospital — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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