Pharmacokinetic and Safety Study of Meropenem in Young Infants With Intra-Abdominal Infections - Full Text View

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00621192

Purpose

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.

Condition	Intervention	Phase
Necrotizing Enterocolitis Intra-Abdominal Infection	Drug: meropenem	Phase I Phase II

Drug Information available for: Meropenem

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 Days) With Suspected or Complicated Intra-Abdominal Infections

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Pharmacokinetics [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

seizure frequency [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	May 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Low dose meropenem	Drug: meropenem Infants <32 weeks: < 2 week PNA: 10mg/kg q 12hr 2-4 weeks PNA: 20mg/kg q 12hr >4 weeks PNA: 20mg/kg q 8hr Infants ≥32 weeks: < 2 weeks PNA: 20mg/kg q 12hr 2-4 weeks PNA: 20mg/kg q 8hr >4 weeks PNA: 30mg/kg q 8hr
2: Active Comparator Medium dose meropenem	Drug: meropenem If the Low Dose arm is tolerated: MEDIUM DOSE Infants <32 weeks: < 2 week PNA: 20mg/kg q 12hr 2-4 weeks PNA: 20mg/kg q 8hr >4 weeks PNA: 30mg/kg q 8hr Infants ≥32 weeks: < 2 weeks PNA: 20mg/kg q 8hr 2-4 weeks PNA: 30mg/kg q 8hr >4 weeks PNA: 40mg/kg q 8hr
3: Active Comparator High dose meropenem	Drug: meropenem If the Medium dose arm is tolerated: HIGH DOSE Infants <32 weeks: < 2 week PNA: 20mg/kg q 8hr 2-4 weeks PNA: 30mg/kg q 8hr >4 weeks PNA: 40mg/kg q 8hr Infants ≥32 weeks: < 2 weeks PNA: 30mg/kg q 8hr 2-4 weeks PNA: 40mg/kg q 8hr >4 weeks PNA: 50mg/kg q 8hr

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:

To characterize meropenem single-dose and multiple-dose PK in subjects with suspected and complicated intra-abdominal infections.
To characterize the safety profile of meropenem in the treatment of suspected and complicated intra-abdominal infections.
To assess collected efficacy data for meropenem for the treatment of suspected and complicated intra-abdominal infections.

Eligibility

Ages Eligible for Study:	up to 90 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621192

Contacts

Contact: Danny Benjamin, MD, PhD, MPH	(919)-668-8295	danny.benjamin@duke.edu
Contact: Katherine Berezny	(919) -668-8453	katherine.berezny@duke.edu

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Danny Benjamin, MD, PhD, MPH

Duke University

More Information

No publications provided

Responsible Party:	NICHD ( Perdita Taylor-Zapata, NICHD/Project Officer )
Study ID Numbers:	HHSN267200700051C, HHSN267200700051C
Study First Received:	February 20, 2008
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00621192 History of Changes
Health Authority:	United States: Food and Drug Administration

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

meropenem
infants
intra-abdominal infection
pharmacokinetics
safety

Study placed in the following topic categories:

Anti-Bacterial Agents
Digestive System Diseases
Gastrointestinal Diseases
Meropenem
Necrotizing Enterocolitis

Intestinal Diseases
Gastroenteritis
Enterocolitis, Necrotizing
Enterocolitis

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Gastrointestinal Diseases
Infection
Intestinal Diseases
Enterocolitis
Pharmacologic Actions

Anti-Bacterial Agents
Digestive System Diseases
Meropenem
Therapeutic Uses
Enterocolitis, Necrotizing
Gastroenteritis

ClinicalTrials.gov processed this record on May 06, 2009