Overview

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

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators:
The Emmes Company, LLC
The EMMES Corporation
Treatments:
Meropenem
Thienamycins
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