Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT00621192
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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
90 Days
Study:
NCT00621192
Study Brief:
Protocol Section:
NCT00621192