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Antibiotic Safety (SCAMP)
Recruiting
Trial ID: NCT01994993
Purpose
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
Official Title
Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)
Eligibility
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.
Intervention(s):
drug: ampicillin and gentamicin and clindamycin
drug: ampicillin and metronidazole and gentamicin
drug: gentamicin and Piperacillin- tazobactam
drug: standard of care antibiotics and metronidazole
drug: metronidazole, clindamycin, or piperacillin-tazobactam
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Bethany Ball
650-725-8342