Antibiotic Safety (SCAMP)

Completed · Phase 2/Phase 3

Conditions studied: Complicated Intra Abdominal Infections

In brief

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

Key facts

Study ID

NCT01994993

Run by

Michael Cohen-Wolkowiez

People needed

260

Starts

2013-12-01

Expected to finish

2017-04-20

Last updated by the study team

2019-05-30

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent obtained from parent(s) or legal guardian(s) (Groups 1-5)
• ≤33 weeks gestation at birth (Groups 1-3, 5)
• ≥34 weeks gestation at birth (Groups 4 and 5)
• PNA <121 days (Groups 1-5)
• Sufficient venous access to permit administration of study drug (intravenous [IV]) (Groups 1-5)
• 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.
• 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*
• History of anaphylaxis in response to study drugs (Groups 1-5)
• Serum creatinine >2 mg/dL within 48 hours on measurement prior to and closest to randomization /first study drug dose (Groups 1- 5)**
• 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)**
• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Arkansas Children's Hospital/Univ of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• Rady Children's Hospital and Health Center — San Diego, California, United States
• University of California San Diego Medical Center — San Diego, California, United States
• Sharp Mary Birch — San Diego, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• University of Florida Jacksonville Healthcare, Inc. — Jacksonville, Florida, United States
• Wolfson Children's Hospital, Shands Medical Center — Jacksonville, Florida, United States
• Georgia Regents University — Augusta, Georgia, United States
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
• Riley Hospital — Indianapolis, Indiana, United States
• Wesley Medical Center — Wichita, Kansas, United States
• University of Kentucky Hospital — Lexington, Kentucky, United States
• Louisana State University Health Sciences Center — Shreveport, Louisiana, United States
• University of Maryland Hospital — Baltimore, Maryland, United States
• Floating Hospital for Children at Tufts Medical Center — Boston, Massachusetts, United States
• University of Minnesota Fairview University Medical Center — Minneapolis, Minnesota, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Kings County Hospital — Brooklyn, New York, United States
• Brookdale University Hospital — Brooklyn, New York, United States
• New York University School of Medicine — New York, New York, United States
• Columbia University Neonatology — New York, New York, United States
• Westchester Medical Center - New York Medical College — Valhalla, New York, United States

Full record on ClinicalTrials.gov

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