Antibiotic Safety (SCAMP)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

January 15, 2017

Study Completion Date

April 20, 2017

Conditions
Complicated Intra Abdominal Infections
Interventions
DRUG

ampicillin and metronidazole and gentamicin

IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

DRUG

ampicillin and gentamicin and clindamycin

IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

DRUG

gentamicin and Piperacillin- tazobactam

IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

DRUG

standard of care antibiotics and metronidazole

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)

DRUG

metronidazole, clindamycin, or piperacillin-tazobactam

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)

Trial Locations (50)

10016

New York University School of Medicine, New York

10032

Columbia University Neonatology, New York

10595

Westchester Medical Center - New York Medical College, Valhalla

11203

Kings County Hospital, Brooklyn

11212

Brookdale University Hospital, Brooklyn

17033

Penn State Hershey Children's Hospital, Hershey

21201

University of Maryland Hospital, Baltimore

22908

University of Virginia Health System, Charlottesville

24014

Carilion Roanoke Memorial Hospital, Roanoke

27157

Wake Forest University School of Medicine, Winston-Salem

27514

University of North Carolina Hospital, Chapel Hill

27610

WakeMed Faculty Neonatology, Raleigh

27710

Duke University Medical Center, Durham

27834

East Carolina University, Greenville

28232

Levine Children's Hospital, Charlotte

28403

New Hanover Reginal Medical Center, Wilmington

29425

Medical University of South Carolina, Charleston

30912

Georgia Regents University, Augusta

32209

University of Florida Jacksonville Healthcare, Inc., Jacksonville

Wolfson Children's Hospital, Shands Medical Center, Jacksonville

35233

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University, Nashville

40536

University of Kentucky Hospital, Lexington

44106

Rainbow Babies and Children's Hospital, Cleveland

45229

Cincinnati Children's Hospital, Cincinnati

46202

Riley Hospital, Indianapolis

55455

University of Minnesota Fairview University Medical Center, Minneapolis

67214

Wesley Medical Center, Wichita

71103

Louisana State University Health Sciences Center, Shreveport

72202

Arkansas Children's Hospital/Univ of Arkansas for Medical Sciences, Little Rock

73104

University of Oklahoma Health Science Center, Oklahoma City

77030

Texas Children's Hospital, Houston

University of Texas Health Science Center at Houston, Houston

84108

Intermountain Medical Center, Salt Lake City

84132

University of Utah, Salt Lake City

92123

Rady Children's Hospital and Health Center, San Diego

University of California San Diego Medical Center, San Diego

92131

Sharp Mary Birch, San Diego

92354

Loma Linda University Medical Center, Loma Linda

94304

Stanford University School of Medicine, Palo Alto

96826

Kapiolani Medical Center for Women and Children, Honolulu

06106

Connecticut Children's Medical Center, Hartford

02111

Floating Hospital for Children at Tufts Medical Center, Boston

07601

Hackensack University Medical Center, Hackensack

02905

Womens and Infant Hospital of Rhode Island, Providence

T5H 3V9

University of Alberta - Royal Alexandra Hospital, Edmonton

V6H 3V4

University of British Columbia - British Columbia Women's Hospital, Vancouver

R3P 2C1

Manitoba Institute of Child Health, Winnipeg

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

T3T 1C5

Hospital Sainte-Justine, Montreal

All Listed Sponsors
collaborator

The Emmes Company, LLC

INDUSTRY

lead

Michael Cohen-Wolkowiez

OTHER

NCT01994993 - Antibiotic Safety (SCAMP) | Biotech Hunter | Biotech Hunter