Education and Training

Antibiotic Safety (SCAMP)

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

Stanford is currently accepting patients for this trial.

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

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.

Ages Eligible for Study

N/A - 120 Days

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Bethany Ball
650-725-8342
Recruiting