Antibiotic Safety (SCAMP)

The most commonly used antibiotics in infants with complicated intra-abdominal infections are
not labeled for use in this population because safety and efficacy data are lacking. This
study will provide the safety information required for labeling. In addition, the
pharmacokinetics(PK) and effectiveness data will also be collected during this study.

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.