Clinical trial

Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 Days) With Suspected or Complicated Intra-abdominal Infections

Name

HHSN267200700051C

Description

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.

Trial arms

Trial start

2008-06-01

Estimated PCD

2009-10-01

Trial end

2009-10-01

Status

Completed

Phase

Early phase I

Treatment

meropenem

Meropenem was administered concomitantly with compatible medications. Because an in-line filter is not appropriate due to drug binding, the 30 minute infusion was rate controlled by using appropriate infusion (syringe) pumps. Dosing and administration of other antimicrobial therapy (e.g., an aminoglycoside) was administered per local standard of care at the discretion of the infant's neonatologist. If there was a delay in the study drug shipment, sites were to use open-label meropenem to protect the safety of the participant. 20 mg/kg every 12 hours in infants \<32 weeks GA and PNA \< 2 weeks 20 mg/kg every 8 hours in infants \<32 weeks GA and PNA ≥ 2 weeks 20 mg/kg every 8 hours in infants ≥32 weeks GA and PNA \< 2 weeks 30 mg/kg every 8 hours in infants ≥32 weeks GA and PNA ≥ 2 weeks

Arms:

Meropenem

Other names:

Merrem

Size

200

Primary endpoint

Efficacy Success (Alive at Efficacy Visit,Last Culture (if Obtained) From Sterile Body Fluid is Negative for Bacteria (Except Staphylococcus Species) From Start of Study Drug Until Efficacy Visit,Presumptive Clinical Cure Score(PCCS) >7 at Efficacy Visit)

Average of 12 days (3 to 21 days)

Deaths

Up to 51 days (Recorded from the time of informed consent until 72 hours following the last dose of study drug)

Meropenem Clearance

Up to 7-8hrs post drug administration

Key Safety Endpoints

Up to 51 days (Adverse Events (AEs) were recorded from the time of informed consent until 72 hours following the last dose of study drug)

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}

Updated at

2023-04-25

1 organization

Organization

The Emmes Company