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:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT01994993
Eligibility Criteria:
Inclusion Criteria:
1. Informed consent obtained from parent(s) or legal guardian(s) (Groups 1-5)
2. ≤33 weeks gestation at birth (Groups 1-3, 5)
3. ≥34 weeks gestation at birth (Groups 4 and 5)
4. PNA \<121 days (Groups 1-5)
5. Sufficient venous access to permit administration of study drug (intravenous \[IV\]) (Groups 1-5)
6. Presenting physical, radiological, and/or bacteriological findings of a complicated intra-abdominal infection within 48 hours prior to randomization/first study drug dose (Groups 1-4)\*\*. Complicated intra-abdominal infections include secondary peritonitis, NEC grade II or higher by Bell's criteria, Hirschsprung's disease with perforation, spontaneous intestinal perforation, meconium ileus with perforation, bowel obstruction with perforation, gastroschisis with necrosis and/or perforation, omphalocele with necrosis and/or perforation, neonatal appendicitis, intestinal pneumatosis or portal venous gas, free peritoneal air on abdominal radiographic examination, or abdominal abscess.
7. Suspected or confirmed infection for which the study drug may provide therapeutic benefit and planned CSF collection per standard of care (Group 5).
Exclusion Criteria\*
1. History of anaphylaxis in response to study drugs (Groups 1-5)
2. Serum creatinine \>2 mg/dL within 48 hours on measurement prior to and closest to randomization /first study drug dose (Groups 1- 5)\*\*
3. Known ALT \>250 U/L or AST \>500 U/L on measurement closest to the time of randomization or first study drug dose (Groups 1-5)\*\*
4. Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety (Groups 1-5)
* Do not apply for Group 5 participants receiving drug per standard of care
* Criteria must be satisfied by randomization (randomized Groups 1-3) or first study drug dose (non-randomized Groups 1-3, Group 4 and Group 5), whichever comes first.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
120 Days
Study:
NCT01994993
Study Brief:
Protocol Section:
NCT01994993