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

The EMMES Corporation

Status and phase: Completed; Phase 2; Phase 1

Conditions: Intra-abdominal Infection; Necrotizing Enterocolitis

Treatments: Drug: meropenem

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621192

HHSN267200700051C (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: Under 90 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Meropenem

Experimental group

Description:

These Participants were subdivided into the following four groups based on Gestational Age (GA) and Postnatal Age (PNA): Group 1: GA at birth below 32 weeks - PNA \<2 weeks; Group 2: GA at birth below 32 weeks - PNA ≥2 weeks and \<91 days; Group 3: GA at birth 32 weeks or older - PNA \<2 weeks; Group 4: GA at birth 32 weeks or older - PNA ≥2 weeks and \<91 days.

Treatment:

Drug: meropenem