CompletedPhase 1/2

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

United States200 participantsStarted 2008-06

Plain-language 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.

Who can participate

Age range90 Days

SexALL

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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 receive study drug.
✓. 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.

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 (Electroencephalogram) confirmed seizures
✕. Concomitant treatment with another carbapenem (ertapenem or imipenem) 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

What they're measuring

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)

Timeframe: Average of 12 days (3 to 21 days)

Deaths

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

Meropenem Clearance

Timeframe: Up to 7-8hrs post drug administration

Key Safety Endpoints

Timeframe: 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)

Trial details

NCT IDNCT00621192

SponsorThe Emmes Company, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-10

Results submitted2011-10-20

View on ClinicalTrials.gov More Necrotizing Enterocolitis trials