Antibiotic Safety (SCAMP)

Condition(s) targeted: Complicated Intra Abdominal Infections

Intervention: ampicillin and metronidazole and gentamicin (Drug); ampicillin and gentamicin and clindamycin (Drug); gentamicin and Piperacillin- tazobactam (Drug); standard of care antibiotics and metronidazole (Drug); metronidazole, clindamycin, or peracillin-tazobactam (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Michael Cohen-Wolkowiez

Official(s) and/or principal investigator(s):
Micheal Cohen-Wolkowiez, MD, PhD, Principal Investigator, Affiliation: Duke University

Overall contact:
Michael Cohen-Wolkowiez, M.D, PhD, Email: michael.cohenwolkowiez@dm.duke.edu

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Death

Secondary outcome: Number of participants with therapeutic success at Day 30 and Day 90

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.

Minimum age: N/A. Maximum age: 120 Days. Gender(s): Both.

Criteria:

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 (Groups 1-3) or prior to first study drug dose (Group 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 prior to randomization (Groups 1-3) or first study drug dose (Groups 4 and 5) 3. Known ALT >250 U/L or AST >500 U/L on measurement closest to the time of randomization (Groups 1-3) or first study drug dose (Groups 4 and 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.

Michael Cohen-Wolkowiez, M.D, PhD, Email: michael.cohenwolkowiez@dm.duke.edu

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States; Recruiting
Claire Roane, RN, Phone: 205-934-0095
Reed Dimmitt, MD, Principal Investigator

University of Alberta - Royal Alexandra Hospital, Edmonton, Alberta T5H 3V9, Canada; Not yet recruiting
Po-Yin Cheung, MD, Phone: 1-780-735-4670, Email: poyin@ualberta.ca

University of British Columbia - British Columbia Women's Hospital, Vancouver, British Columbia V6H 3V4, Canada; Not yet recruiting
Joseph Ting, MD, Phone: 1-604-875-2345, Email: jting2@cw.bc.ca

Loma Linda University Medical Center, Loma Linda, California 92354, United States; Recruiting
Adrian Lavery, MD, Phone: 909-558-4800, Email: alavery@llu.edu

Children's Hospital of Orange County Research Institute, Orange, California 92868, United States; Withdrawn

Stanford University School of Medicine, Palo Alto, California 94304, United States; Not yet recruiting
Bethany Ball, Phone: 650-725-8342
Krisa Van Meurs, MD, Principal Investigator

Rady Childrens Hospital and Health Center, San Diego, California 92123, United States; Not yet recruiting
Ellen Knodel, Phone: 858-966-7483
Mark Speziale, MD, Principal Investigator

Sharp Mary Birch, San Diego, California 92131, United States; Recruiting
Deborah Petruzzelli, RN, Phone: 858-939-4891
Anup Katheria, MD, Principal Investigator

University of California San Diego Medical Center, San Diego, California 92103, United States; Recruiting
Jae Kim, MD, Phone: 619-543-5526, Email: neojae@ucsd.edu

University of Florida Jacksonville Healthcare, Inc., Jacksonville, Florida 32209, United States; Recruiting
Renee Prince, RN, Phone: 904-244-3866
Mark Hudak, MD, Principal Investigator

Wolfson Children's Hospital, Shands Medical Center, Jacksonville, Florida 32209, United States; Recruiting
Renee Prince, RN, Phone: 904-244-3866
Mark Hudak, MD, Principal Investigator

University of Miami, Miami, Florida 33136, United States; Withdrawn

Emory University Children's Center, Atlanta, Georgia 30322, United States; Recruiting
Paul Spearman, MD, Phone: 404-785-1999
Paul Spearman, MD, Principal Investigator

Georgia Regents University, Augusta, Georgia 30912, United States; Not yet recruiting
Jatinder Bhatia, MD, Phone: 706-721-2331, Email: jatindeb@gru.edu

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii 96826, United States; Recruiting
Micah Tong, Phone: 808-983-6427
Venkataraman Balaraman, MD, Principal Investigator

Riley Hospital, Indianapolis, Indiana 46202, United States; Recruiting
Lucy Smiley, RN, Phone: 317-278-7364
Brenda Poindexter, MD, Principal Investigator

Wesley Medical Center, Wichita, Kansas 67214, United States; Recruiting
Paula Delmore, RN, Phone: 316-962-8555
Barry Bloom, MD, Principal Investigator

University of Kentucky Hospital, Lexington, Kentucky 40536, United States; Not yet recruiting
Hubert Ballard, MD, Phone: 859-323-1850, Email: hoball2@uky.edu

Louisana State University Health Sciences Center, Shreveport, Louisiana 71103, United States; Withdrawn

Manitoba Institute of Child Health, Winnipeg, Manitoba R3P 2C1, Canada; Not yet recruiting
Michael Narvey, MD, Phone: 1-204-787-2720, Email: mnarvey@hsc.mb.ca
Michael Narvey, MD, Principal Investigator

University of Maryland Hospital, Baltimore, Maryland 21201, United States; Recruiting
Donna Cannonier, RN, Phone: 410-328-2438
Susan Mendley, MD, Principal Investigator

Floating Hospital for Children at Tufts Medical Center, Boston, Massachusetts 02111, United States; Recruiting
Christiane Dammann, MD, Phone: 617-636-8738, Email: cdammann@tuftsmedicalcenter.org

Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota 55404, United States; Recruiting
Ellen Bendel-Stenzel, MD, Phone: 612-813-6475, Email: ellen.bendel-stenzel@childrensmn.org

University of Minnesota Fairview University Medical Center, Minneapolis, Minnesota 55455, United States; Recruiting
Mary Pat Osborne, RN, Phone: 1-612-624-0581
Catherine Bendel, MD, Principal Investigator

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Ritu Banerjee, MD, Phone: 507-255-8464, Email: banerjee.ritu@mayo.edu

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States; Recruiting
Mary Ellen Riordan, Phone: 551-996-8126
Rakesh Chhabra, MD, Principal Investigator

University of New Mexico Hospital, Albuquerque, New Mexico 87131, United States; Withdrawn

Brookdale University Hospital, Brooklyn, New York 11212, United States; Recruiting
Chika Iwuchukwu, Phone: 718-240-5668
Roger Kim, MD, Principal Investigator

Kings County Hospital, Brooklyn, New York 11203, United States; Recruiting
Gratias Mundakel, MD, Phone: 718-844-9839
Gratias Mundakel, MD, Principal Investigator

SUNY Downstate Medical Center, Brooklyn, New York 11203, United States; Recruiting
Rudolph Parris, Phone: 718-270-4657
Gloria Valencia, MD, Principal Investigator

Columbia University Neonatology, New York, New York 10032, United States; Recruiting
Marilyn Weindler, Phone: 212-305-3677
Marianne Garland, MBChB, Principal Investigator

New York University School of Medicine, New York, New York 10016, United States; Recruiting
Nagamah Deygoo, Phone: 212-263-5680
William Borkowsky, MD, Principal Investigator

Westchester Medical Center - New York Medical College, Valhalla, New York 10595, United States; Not yet recruiting
Lance Parton, MD, Phone: 914-493-8558, Email: lance_parton@cwpw.org

University of North Carolina Hospital, Chapel Hill, North Carolina 27514, United States; Recruiting
Janice Bernhardt, RN, Phone: 919-843-2373
Matthew Laughon, MD, Principal Investigator

Levine Children's Hospital, Charlotte, North Carolina 28232, United States; Recruiting
Jennifer Reeves, Phone: 704-347-4051
Matthew Saxonhouse, MD, Principal Investigator

Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Kimberley Fisher, Pharm.D, Phone: 919-681-4913
C. Michael Cotten, MD, Principal Investigator

East Carolina University, Greenville, North Carolina 27834, United States; Recruiting
Sherry Moseley, Phone: 252-744-5368
Scott MacGilvray, MD, Principal Investigator

WakeMed Faculty Neonatology, Raleigh, North Carolina 27610, United States; Recruiting
Ginger Rhodes-Ryan, Phone: 919-350-7026
James Perciaccante, MD, Principal Investigator

New Hanover Reginal Medical Center, Wilmington, North Carolina 28403, United States; Recruiting
Fernando Moya, MD, Phone: 910-667-2724, Email: fernando.moya@ccneo.net

Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157, United States; Recruiting
Kelly Warden, Phone: 336-718-3091
Laura Downey, MD, Principal Investigator

Akron Children's Hospital, Akron, Ohio 48109, United States; Recruiting
Judy Ohlinger, RN, Phone: 330-543-3193
Michael Reed, Pharm.D, Principal Investigator

Cincinnati Children's Hospital, Cincinnati, Ohio 45229, United States; Recruiting
Stuart Goldstein, MD, Phone: 513-803-3294
Stuart Goldstein, MD, Principal Investigator

Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio 45229, United States; Recruiting
Stuart Goldstein, MD, Phone: 513-803-3295, Email: stuart.goldstein@cchmc.org

Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106, United States; Recruiting
Sue Bergant, Phone: 216-844-5112
Andrea Trembath, MD, Principal Investigator

University of Oklahoma Health Science Center, Oklahoma City, Oklahoma 73104, United States; Recruiting
Hala Chaaban, MD, Phone: 405-271-5215, Email: hala-chaaban@ouhsc.edu

Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H 8L1, Canada; Not yet recruiting
Thierry Lacaze, MD, Phone: 1-613-737-7600, Email: tlacaze@cheo.on.ca

Hospital Sainte-Justine, Montreal, Quebec T3T 1C5, Canada; Not yet recruiting
Julie Autmizguine, MD, Phone: 1-514-345-4391, Email: julie.autmizguine.hsj@ssss.gouv.qc.ca
Julie Autmizguine, MD, Principal Investigator

Womens and Infant Hospital of Rhode Island, Providence, Rhode Island 02905, United States; Recruiting
Jane Chandley, Phone: 401-274-1122
Joseph Bliss, MD, Principal Investigator

Medical University of South Carolina, Charleston, South Carolina 29425, United States; Recruiting
Andrew Atz, MD, Phone: 843-792-0080
Andrew Atz, MD, Principal Investigator

Vanderbilt University, Nashville, Tennessee 37232, United States; Recruiting
Steven Steele, Phone: 615-322-0299
Jorn-Hendrik Weitkamp, MD, Principal Investigator

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States; Recruiting
Angelia Riley, Phone: 214-456-8072
James Moore, MD, Principal Investigator

University of Texas Medical Branch/Inside Delivery, Galveston, Texas 77555, United States; Withdrawn

University of Texas Health Science Center at Houston, Houston, Texas 77030, United States; Recruiting
Elizabeth Aguilera, Phone: 713-500-5522
Gloria Heresi, MD, Principal Investigator

Intermountain Medical Center, Salt Lake City, Utah 84108, United States; Not yet recruiting
Erin Zinkhan, MD, Phone: 801-581-7052, Email: erin.zinkhan@hsc.utah.edu

University of Utah, Salt Lake City, Utah 84132, United States; Recruiting
Cindy Spencer, Phone: 801-662-4123
Erin Zinkhan, MD, Principal Investigator

University of Virginia Health System, Charlottesville, Virginia 22908, United States; Recruiting
Amy Blackman, RN, Phone: 434-982-0263
David Kaufman, MD, Principal Investigator

Carilion Roanoke Memorial Hospital, Roanoke, Virginia 24014, United States; Not yet recruiting
Pradeep Siwach, Phone: 540-266-6012
Shawn Safford, MD, Principal Investigator

Starting date: December 2013
Last updated: April 6, 2015