Antibiotic Safety (SCAMP)
- Conditions
- Complicated Intra Abdominal Infections
- Interventions
- Registration Number
- NCT01994993
- Lead Sponsor
- Michael Cohen-Wolkowiez
- Brief 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- 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.
-
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 4 (metronidazole) standard of care antibiotics and metronidazole Per standard of care antibiotics, and Metronidazole Group 5 (metronidazole/clindamycin/piperacillin-tazobactam) metronidazole, clindamycin, or piperacillin-tazobactam metronidazole, clindamycin, or piperacillin-tazobactam Group 1 (ampicillin +gentamycin +metronidazole) ampicillin and metronidazole and gentamicin Ampicillin and gentamycin and metronidazole Group 2 (ampicillin +gentamicin+clindamycin) ampicillin and gentamicin and clindamycin ampicillin and gentamicin and clindamycin Group 3 (piperacillin-tazobactam and gentamicin) gentamicin and Piperacillin- tazobactam piperacillin-tazobactam and gentamicin
- Primary Outcome Measures
Name Time Method Death Within 30 days after last dose of study drug, up to 40 days Number of Participants who experienced Death
- Secondary Outcome Measures
Name Time Method Number of Participants With Therapeutic Success at Day 30 30 days after last dose of study drug Confirmed by 1).Alive, 2).Negative bacterial blood cultures, and 3). Clinical cure score \>4.
Clinical cure score =1 for each of the following elements:
FiO2 ≤ baseline FiO2; Urine output ≥1 mL/kg/h for 24-hour period prior to assessment; Absence of inotropic support at time of assessment; Absence of mechanical ventilation at time of assessment; No seizure in 24-hour period prior to assessment; pH ≥7.25 or not measured in 24 hours prior to assessment
Trial Locations
- Locations (50)
Floating Hospital for Children at Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Westchester Medical Center - New York Medical College
🇺🇸Valhalla, New York, 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
Rady Children's Hospital and Health Center
🇺🇸San Diego, California, United States
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
Riley Hospital
🇺🇸Indianapolis, Indiana, United States
University of Maryland Hospital
🇺🇸Baltimore, Maryland, United States
Louisana State University Health Sciences Center
🇺🇸Shreveport, Louisiana, 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
Levine Children's Hospital
🇺🇸Charlotte, North Carolina, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
New Hanover Reginal Medical Center
🇺🇸Wilmington, North Carolina, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Womens and Infant Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Carilion Roanoke Memorial Hospital
🇺🇸Roanoke, Virginia, United States
University of British Columbia - British Columbia Women's Hospital
🇨🇦Vancouver, British Columbia, Canada
Manitoba Institute of Child Health
🇨🇦Winnipeg, Manitoba, Canada
Hospital Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Penn State Hershey Children's Hospital
🇺🇸Hershey, Pennsylvania, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Intermountain Medical Center
🇺🇸Salt Lake City, Utah, United States
Sharp Mary Birch
🇺🇸San Diego, California, United States
WakeMed Faculty Neonatology
🇺🇸Raleigh, North Carolina, United States
University of Alberta - Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Minnesota Fairview University Medical Center
🇺🇸Minneapolis, Minnesota, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Oklahoma Health Science Center
🇺🇸Oklahoma City, Oklahoma, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
University of Kentucky Hospital
🇺🇸Lexington, Kentucky, United States
University of North Carolina Hospital
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Florida Jacksonville Healthcare, Inc.
🇺🇸Jacksonville, Florida, United States
Wolfson Children's Hospital, Shands Medical Center
🇺🇸Jacksonville, Florida, United States
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States