Phase 2
N=200
Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections
Necrotizing Enterocolitis · Intra-abdominal Infection
Bottom Line
View on ClinicalTrials.gov: NCT00621192 ↗Enrolled (actual)
200
Serious AEs
17.0%
Results posted
Nov 2011
Primary outcome: Primary: 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) — 29; 82; 26; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- meropenem (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- The Emmes Company, LLC
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
29; 82; 26; 25 | — |
| PRIMARY Deaths |
3; 8; 0; 0 | — |
| PRIMARY Meropenem Clearance |
0.089; 0.122; 0.135; 0.202 | — |
| PRIMARY Key Safety Endpoints |
3; 8; 0; 0; 4; 3 | — |
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.
Eligibility 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 receive study drug.
AND ONE OF THE FOLLOWING
- 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
- Renal dysfunction evidenced by urine output 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
Data sourced from ClinicalTrials.gov (NCT00621192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.