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

Information source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Necrotizing Enterocolitis; Intra-abdominal Infection

Intervention: meropenem (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Official(s) and/or principal investigator(s):
Danny Benjamin, MD, PhD, MPH, Principal Investigator, Affiliation: Duke University

Summary

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.

Clinical Details

Official title: Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 Days) With Suspected or Complicated Intra-abdominal Infections

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Efficacy Success (Alive at Efficacy Visit,Last Culture (if Obtained) From Sterile Body Fluid is Negative for Bacteria (Except Staphylococcus Species) From Start of Study Drug Until Efficacy Visit,Presumptive Clinical Cure Score(PCCS) >7 at Efficacy Visit)

Deaths

Meropenem Clearance

Key Safety Endpoints

Detailed description:

This study will evaluate the safety, tolerability and Pharmacokinetics - Pharmacodynamics

(PK-PD) of meropenem in infants <91 days of age with suspected and complicated intra-abdominal infections. The specific aims of this trial are: 1. To characterize meropenem single-dose and multiple-dose PK in subjects with suspected and complicated intra-abdominal infections. 2. To characterize the safety profile of meropenem in the treatment of suspected and complicated intra-abdominal infections. 3. To assess collected efficacy data for meropenem for the treatment of suspected and complicated intra-abdominal infections.

Eligibility

Minimum age: N/A. Maximum age: 90 Days. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Written permission from parent or legal guardian 2. Age younger than 91 days 3. Likely to survive beyond the first 48 hours after enrollment 4. Sufficient intravascular access (either peripheral or central) to receive study drug. AND ONE OF THE FOLLOWING 5. 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 Exclusion criteria: 1. Renal dysfunction evidenced by urine output <0. 5 mL/hr/kg over the prior 24 hours 2. Serum creatinine >1. 7 mg/dL 3. History of clinical seizures or EEG (Electroencephalogram) confirmed seizures 4. Concomitant treatment with another carbapenem (ertapenem or imipenem) at the time of informed consent 5. Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study

Locations and Contacts

University of Alabama, Birmingham, Alabama 35233, United States

Children's Hospital of Oakland, Oakland, California 94609, United States

Children's Hospital of Orange County, Orange, California 92868, United States

Sharp-Mary Birch Hospital for Women, San Diego, California 92123, United States

University of California Medical Center, San Diego, California 92117, United States

Yale New Haven Hospital, New Haven, Connecticut, United States

Children's National Medical Center, Washington DC, District of Columbia 20010, United States

University of Florida, Gainesville, Florida 32610, United States

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii 96826, United States

Evanston Northwestern Healthcare, Evanston, Illinois 60056, United States

Indiana University - Riley Hospital for Children, Indianapolis, Indiana 46202, United States

University of Louisville, Louisville, Kentucky 40202, United States

University of Michigan, Ann Arbor, Michigan 48109, United States

Kansas City Children's Mercy Hospital, Kansas City, Missouri 64108, United States

Albany Medical Center, Albany, New York 12208, United States

Suny Downstate Medical Center, Brooklyn, New York 11203, United States

Duke University, Durham, North Carolina 27715, United States

Duke University Medical Center, Durham, North Carolina 27708, United States

Akron Children's Hospital, Akron, Ohio 44308, United States

Case Western Reserve, RB&C, UHCMC, Cleveland, Ohio 44106, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Magee Women's Hospital, Pittsburg, Pennsylvania 15213, United States

Vanderbilt Children's Hospital, Nashville, Tennessee 37232, United States

University of Texas Southwestern Medical Center, Dallas, Texas, United States

Baylor College of Medicine, Houston, Texas 77030, United States

University of Utah medical Center, Salt lake City, Utah 84108, United States

Additional Information

Starting date: June 2008
Last updated: March 30, 2015

Page last updated: August 23, 2015

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