Antibiotic Safety (SCAMP)



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:7/27/2018
Start Date:December 2013
End Date:April 20, 2017

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Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)

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

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.

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.
We found this trial at
46
sites
282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Principal Investigator: Naveed Hussain, MD
Phone: 860-679-4331
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: George El-Ferzli, MD
Phone: 205-934-4680
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Principal Investigator: Andrea Trembath, MD
Phone: 216-844-3387
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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Cleveland, OH
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Gloria Heresi, MD
Phone: 713-500-5522
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Erin Zinkhan, MD
Phone: 801-213-3360
University of Utah Research is a major component in the life of the U benefiting...
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Phone: 706-721-2331
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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Baltimore, Maryland 21201
Principal Investigator: Susan Mendley, MD
Phone: 410-328-2438
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Boston, Massachusetts 02111
Principal Investigator: Christiane Dammann, MD
Phone: 617-636-8738
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Brooklyn, New York 11203
Principal Investigator: Gratias Mundakel, MD
Phone: 718-844-9839
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Brooklyn, New York 11212
Principal Investigator: Roger Kim, MD
Phone: 718-240-5668
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Chapel Hill, North Carolina 27599
Principal Investigator: Matthew Laughon, MD
Phone: 919-843-2373
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Andrew Atz, MD
Phone: 843-792-0080
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28204
Principal Investigator: Matthew Saxonhouse, MD
Phone: 704-347-4051
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: David Kaufman, MD
Phone: 434-924-5428
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Cincinnati, Ohio 45229
Principal Investigator: Stuart Goldstein, MD
Phone: 513-803-3294
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: C. Michael Cotten, MD
Phone: 919-681-4913
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Edmonton, Alberta
Phone: 1-780-735-4670
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: Scott MacGilvray, MD
Phone: 252-744-5368
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Greenville, NC
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Rakesh Chhabra, MD
Phone: 551-996-8126
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-8521
Principal Investigator: Jessica Ericson, MD
Phone: 717-531-3049
Penn State Hershey Children's Hospital Penn State Milton S. Hershey Medical Center, Penn State College...
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Principal Investigator: Venkataraman Balaraman, MD
Phone: 808-983-6427
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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Honolulu, HI
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Ganga Gokulakrishnan, MD
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Indianapolis, Indiana
Principal Investigator: Gregory Sokol, MD
Phone: 317-274-4768
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Jacksonville, Florida 32209
Principal Investigator: Mark Hudak, MD
Phone: 904-244-7760
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Jacksonville, Florida 32209
Principal Investigator: Mark Hudak, MD
Phone: 904-244-7760
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Lexington, Kentucky 40536
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Little Rock, Arkansas 72202
Principal Investigator: Sherry Courtney, MD
Phone: 501-364-6990
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Adrian Lavery, MD
Phone: 909-558-4800
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Minneapolis, Minnesota 55455
Principal Investigator: Catherine Bendel, MD
Phone: 1-612-624-0581
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Jorn-Hendrik Weitkamp, MD
Phone: 615-322-0299
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: William Borkowsky, MD
Phone: 212-263-5680
New York University School of Medicine NYU School of Medicine has a proud history that...
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New York, New York 10032
Principal Investigator: Marianne Garland, MBChB
Phone: 212-305-3677
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Oklahoma City, Oklahoma 73104
Principal Investigator: Hala Chaaban, MD
Phone: 405-271-5215
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Palo Alto, California 94304
Principal Investigator: Krisa Van Meurs, MD
Phone: 650-725-8342
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Providence, Rhode Island 02905
Principal Investigator: Joseph Bliss, MD
Phone: 401-274-1122
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Raleigh, North Carolina 27610
Principal Investigator: James Perciaccante, MD
Phone: 919-350-7026
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Roanoke, Virginia 24033
Principal Investigator: Shawn Safford, MD
Phone: 540-266-6012
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Salt Lake City, Utah 84157
Principal Investigator: Erin Zinkhan, MD
Phone: 801-581-7052
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San Diego, California 92123
Principal Investigator: Mark Speziale, MD
Phone: 858-966-7483
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San Diego, California 92103
Principal Investigator: Jae Kim, MD
Phone: 619-543-3812
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San Diego, California 92123
Principal Investigator: Anup Katheria, MD
Phone: 858-939-4299
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Valhalla, New York 10595
Phone: 914-493-8558
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550 N Hillside St
Wichita, Kansas 67214
(316) 962-2000
Principal Investigator: Barry Bloom, MD
Phone: 316-962-8555
Wesley Medical Center Welcome to one of the most experienced and comprehensive medical centers in...
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Wilmington, North Carolina 28403
Phone: 910-667-2724
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Winston-Salem, North Carolina 26157
Principal Investigator: Laura Downey, MD
Phone: 336-713-0628
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