Status:
COMPLETED
Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections
Lead Sponsor:
The Emmes Company, LLC
Conditions:
Necrotizing Enterocolitis
Intra-abdominal Infection
Eligibility:
All Genders
Up to 90 years
Phase:
PHASE1
PHASE2
Brief 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 determi...
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. T...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00621192
Start Date
June 1 2008
End Date
October 1 2009
Last Update
April 25 2023
Active Locations (26)
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1
University of Alabama
Birmingham, Alabama, United States, 35233
2
Children's Hospital of Oakland
Oakland, California, United States, 94609
3
Children's Hospital of Orange County
Orange, California, United States, 92868
4
University of California Medical Center
San Diego, California, United States, 92117