Antibiotic Safety (SCAMP)

• Status: Completed
• Trial end date: 2017-04-20
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is evaluate whether it is safe or not to use various combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, gentamicin) in treating infants with complicated intra-abdominal infections

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Cohen-Wolkowiez
• Collaborators: The Emmes Company, LLC; The EMMES Corporation
• Treatments: Ampicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Gentamicins; Metronidazole; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

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.