Antibiotic Safety (SCAMP)
SCAMP
Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)
2 other identifiers
interventional
260
2 countries
50
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2013
Typical duration for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
November 26, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2017
CompletedResults Posted
Study results publicly available
February 27, 2018
CompletedMay 30, 2019
May 1, 2019
3.1 years
November 18, 2013
January 15, 2018
May 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death
Number of Participants who experienced Death
Within 30 days after last dose of study drug, up to 40 days
Secondary Outcomes (1)
Number of Participants With Therapeutic Success at Day 30
30 days after last dose of study drug
Other Outcomes (9)
Number of Participants With Feeding Intolerance
90 days after last dose of study drug
Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH)
90 days after last dose of study drug
Number of Participants With Short Bowel Syndrome
90 days after last dose of study drug
- +6 more other outcomes
Study Arms (5)
Group 1 (ampicillin +gentamycin +metronidazole)
ACTIVE COMPARATORAmpicillin and gentamycin and metronidazole
Group 2 (ampicillin +gentamicin+clindamycin)
ACTIVE COMPARATORampicillin and gentamicin and clindamycin
Group 3 (piperacillin-tazobactam and gentamicin)
ACTIVE COMPARATORpiperacillin-tazobactam and gentamicin
Group 4 (metronidazole)
ACTIVE COMPARATORPer standard of care antibiotics, and Metronidazole
Group 5 (metronidazole/clindamycin/piperacillin-tazobactam)
ACTIVE COMPARATORmetronidazole, clindamycin, or piperacillin-tazobactam
Interventions
IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Eligibility Criteria
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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michael Cohen-Wolkowiezlead
- The Emmes Company, LLCcollaborator
Study Sites (50)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Arkansas Children's Hospital/Univ of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Stanford University School of Medicine
Palo Alto, California, 94304, United States
Rady Children's Hospital and Health Center
San Diego, California, 92123, United States
University of California San Diego Medical Center
San Diego, California, 92123, United States
Sharp Mary Birch
San Diego, California, 92131, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
University of Florida Jacksonville Healthcare, Inc.
Jacksonville, Florida, 32209, United States
Wolfson Children's Hospital, Shands Medical Center
Jacksonville, Florida, 32209, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Riley Hospital
Indianapolis, Indiana, 46202, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
University of Kentucky Hospital
Lexington, Kentucky, 40536, United States
Louisana State University Health Sciences Center
Shreveport, Louisiana, 71103, United States
University of Maryland Hospital
Baltimore, Maryland, 21201, United States
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of Minnesota Fairview University Medical Center
Minneapolis, Minnesota, 55455, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Kings County Hospital
Brooklyn, New York, 11203, United States
Brookdale University Hospital
Brooklyn, New York, 11212, United States
New York University School of Medicine
New York, New York, 10016, United States
Columbia University Neonatology
New York, New York, 10032, United States
Westchester Medical Center - New York Medical College
Valhalla, New York, 10595, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, 27514, United States
Levine Children's Hospital
Charlotte, North Carolina, 28232, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27834, United States
WakeMed Faculty Neonatology
Raleigh, North Carolina, 27610, United States
New Hanover Reginal Medical Center
Wilmington, North Carolina, 28403, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17033, United States
Womens and Infant Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Intermountain Medical Center
Salt Lake City, Utah, 84108, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
University of Alberta - Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
University of British Columbia - British Columbia Women's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
Manitoba Institute of Child Health
Winnipeg, Manitoba, R3P 2C1, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Hospital Sainte-Justine
Montreal, Quebec, T3T 1C5, Canada
Related Publications (1)
Smith MJ, Boutzoukas A, Autmizguine J, Hudak ML, Zinkhan E, Bloom BT, Heresi G, Lavery AP, Courtney SE, Sokol GM, Cotten CM, Bliss JM, Mendley S, Bendel C, Dammann CEL, Weitkamp JH, Saxonhouse MA, Mundakel GT, Debski J, Sharma G, Erinjeri J, Gao J, Benjamin DK Jr, Hornik CP, Smith PB, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Antibiotic Safety and Effectiveness in Premature Infants With Complicated Intraabdominal Infections. Pediatr Infect Dis J. 2021 Jun 1;40(6):550-555. doi: 10.1097/INF.0000000000003034.
PMID: 33902072DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael Cohen-Wolkowiez, M.D
- Organization
- Duke University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Micheal Cohen-Wolkowiez, MD, PhD
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 18, 2013
First Posted
November 26, 2013
Study Start
December 1, 2013
Primary Completion
January 15, 2017
Study Completion
April 20, 2017
Last Updated
May 30, 2019
Results First Posted
February 27, 2018
Record last verified: 2019-05