Pharmacokinetic 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)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Necrotizing Enterocolitis; Intra-Abdominal Infection
Intervention: meropenem (Drug); meropenem (Drug); meropenem (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
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
Overall contact:
Danny Benjamin, MD, PhD, MPH, Phone: (919)-668-8295, Email: danny.benjamin@duke.edu
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: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Pharmacokinetics
Secondary outcome: seizure frequency
Detailed description:
This study will evaluate the safety, tolerability and 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:
- 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 complete study procedures Physical, radiological,
and/or bacteriological findings of a complicated intra-abdominal infection. These
include peritonitis, NEC 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 confirmed seizures
Concomitant treatment with another carbapenem 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
Locations and Contacts
Danny Benjamin, MD, PhD, MPH, Phone: (919)-668-8295, Email: danny.benjamin@duke.edu
Duke University, Durham, North Carolina 27715, United States; Recruiting
Danny Benjamin, MD, PhD, Phone: 919-668-8295, Email: danny.benjamin@duke.edu
Katherine Berezny, MPH, Phone: (919)-668-8453, Email: katherine.berezny@duke.edu
Danny Benjamin, MD, PhD, Principal Investigator
Additional Information
Starting date: June 2008
Ending date: June 2010
Last updated: May 26, 2009
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