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Antibiotic Safety (SCAMP) (SCAMP)

Primary Purpose

Complicated Intra Abdominal Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ampicillin and metronidazole and gentamicin
ampicillin and gentamicin and clindamycin
gentamicin and Piperacillin- tazobactam
standard of care antibiotics and metronidazole
metronidazole, clindamycin, or piperacillin-tazobactam
Sponsored by
Michael Cohen-Wolkowiez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complicated Intra Abdominal Infections focused on measuring Antibiotics, ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, Safety, Infants, Intra abdominal infections

Eligibility Criteria

undefined - 120 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Arkansas Children's Hospital/Univ of Arkansas for Medical Sciences
  • Loma Linda University Medical Center
  • Stanford University School of Medicine
  • Rady Children's Hospital and Health Center
  • University of California San Diego Medical Center
  • Sharp Mary Birch
  • Connecticut Children's Medical Center
  • University of Florida Jacksonville Healthcare, Inc.
  • Wolfson Children's Hospital, Shands Medical Center
  • Georgia Regents University
  • Kapiolani Medical Center for Women and Children
  • Riley Hospital
  • Wesley Medical Center
  • University of Kentucky Hospital
  • Louisana State University Health Sciences Center
  • University of Maryland Hospital
  • Floating Hospital for Children at Tufts Medical Center
  • University of Minnesota Fairview University Medical Center
  • Hackensack University Medical Center
  • Kings County Hospital
  • Brookdale University Hospital
  • New York University School of Medicine
  • Columbia University Neonatology
  • Westchester Medical Center - New York Medical College
  • University of North Carolina Hospital
  • Levine Children's Hospital
  • Duke University Medical Center
  • East Carolina University
  • WakeMed Faculty Neonatology
  • New Hanover Reginal Medical Center
  • Wake Forest University School of Medicine
  • Cincinnati Children's Hospital
  • Rainbow Babies and Children's Hospital
  • University of Oklahoma Health Science Center
  • Penn State Hershey Children's Hospital
  • Womens and Infant Hospital of Rhode Island
  • Medical University of South Carolina
  • Vanderbilt University
  • Texas Children's Hospital
  • University of Texas Health Science Center at Houston
  • Intermountain Medical Center
  • University of Utah
  • University of Virginia Health System
  • Carilion Roanoke Memorial Hospital
  • University of Alberta - Royal Alexandra Hospital
  • University of British Columbia - British Columbia Women's Hospital
  • Manitoba Institute of Child Health
  • Children's Hospital of Eastern Ontario
  • Hospital Sainte-Justine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1 (ampicillin +gentamycin +metronidazole)

Group 2 (ampicillin +gentamicin+clindamycin)

Group 3 (piperacillin-tazobactam and gentamicin)

Group 4 (metronidazole)

Group 5 (metronidazole/clindamycin/piperacillin-tazobactam)

Arm Description

Ampicillin and gentamycin and metronidazole

ampicillin and gentamicin and clindamycin

piperacillin-tazobactam and gentamicin

Per standard of care antibiotics, and Metronidazole

metronidazole, clindamycin, or piperacillin-tazobactam

Outcomes

Primary Outcome Measures

Death
Number of Participants who experienced Death

Secondary Outcome Measures

Number of Participants With Therapeutic Success at Day 30
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

Full Information

First Posted
November 18, 2013
Last Updated
May 28, 2019
Sponsor
Michael Cohen-Wolkowiez
Collaborators
The Emmes Company, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01994993
Brief Title
Antibiotic Safety (SCAMP)
Acronym
SCAMP
Official Title
Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 15, 2017 (Actual)
Study Completion Date
April 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Cohen-Wolkowiez
Collaborators
The Emmes Company, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Intra Abdominal Infections
Keywords
Antibiotics, ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, Safety, Infants, Intra abdominal infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (ampicillin +gentamycin +metronidazole)
Arm Type
Active Comparator
Arm Description
Ampicillin and gentamycin and metronidazole
Arm Title
Group 2 (ampicillin +gentamicin+clindamycin)
Arm Type
Active Comparator
Arm Description
ampicillin and gentamicin and clindamycin
Arm Title
Group 3 (piperacillin-tazobactam and gentamicin)
Arm Type
Active Comparator
Arm Description
piperacillin-tazobactam and gentamicin
Arm Title
Group 4 (metronidazole)
Arm Type
Active Comparator
Arm Description
Per standard of care antibiotics, and Metronidazole
Arm Title
Group 5 (metronidazole/clindamycin/piperacillin-tazobactam)
Arm Type
Active Comparator
Arm Description
metronidazole, clindamycin, or piperacillin-tazobactam
Intervention Type
Drug
Intervention Name(s)
ampicillin and metronidazole and gentamicin
Intervention Description
IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Intervention Type
Drug
Intervention Name(s)
ampicillin and gentamicin and clindamycin
Intervention Description
IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Intervention Type
Drug
Intervention Name(s)
gentamicin and Piperacillin- tazobactam
Intervention Description
IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Intervention Type
Drug
Intervention Name(s)
standard of care antibiotics and metronidazole
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
metronidazole, clindamycin, or piperacillin-tazobactam
Intervention Description
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)
Primary Outcome Measure Information:
Title
Death
Description
Number of Participants who experienced Death
Time Frame
Within 30 days after last dose of study drug, up to 40 days
Secondary Outcome Measure Information:
Title
Number of Participants With Therapeutic Success at Day 30
Description
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
Time Frame
30 days after last dose of study drug
Other Pre-specified Outcome Measures:
Title
Number of Participants With Feeding Intolerance
Description
Feeding intolerance confirmed by documentation of any feedings held for >24 consecutive hours in infants being fed
Time Frame
90 days after last dose of study drug
Title
Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH)
Description
Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement Grade 4 IVH: Intraparenchymal hemorrhage
Time Frame
90 days after last dose of study drug
Title
Number of Participants With Short Bowel Syndrome
Description
Short bowel syndrome: Operative reports documenting resection of bowel, estimated bowel length, and absence/presence of the ileocecal valve. Total parenteral nutrition for >42 consecutive days after bowel resection, or a residual small bowel length of less than 25% expected for gestational age
Time Frame
90 days after last dose of study drug
Title
Number of Participants With Intestinal Perforation
Description
Intestinal perforation: Radiological reports leading to the diagnosis of intestinal perforation. These include plain chest x-rays, plain abdominal x-rays, ultra-sonograms of the abdomen, contrast studies, and computed tomography scans of the abdomen and pelvis. Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal perforation. These include placement of a surgical drain, laparotomy, intestinal resection, and ostomy placement
Time Frame
90 days after last dose of study drug
Title
Number of Participants With Intestinal Stricture
Description
Intestinal stricture: Radiology reports leading to the diagnosis of intestinal stricture. These include plain abdominal x-rays, upper gastrointestinal series with small bowel follow-through, contrast enema studies, and computed tomography scans of the abdomen and pelvis. Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal stricture. These procedures include endoscopy, laparotomy, stricture dilatation, intestinal resection, and ostomy placement
Time Frame
90 days after last dose of study drug
Title
Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection
Description
Progression is determined by the clinical NEC scoring
Time Frame
90 days after last dose of study drug
Title
Number of Participants With Gastrointestinal Surgeries
Description
Determined by medical history and confirmed with hospital records. (Laparotomy)
Time Frame
90 days after last dose of study drug
Title
Number of Participants With Seizure
Description
documented seizure(s) in hospital records
Time Frame
90 days after last dose of study drug
Title
Number of Participants With Positive Blood Cultures
Description
Positive blood culture (bacterial or fungal)
Time Frame
90 days after last dose of study drug

10. Eligibility

Sex
All
Maximum Age & Unit of Time
120 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Micheal Cohen-Wolkowiez, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Arkansas Children's Hospital/Univ of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Rady Children's Hospital and Health Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Mary Birch
City
San Diego
State/Province
California
ZIP/Postal Code
92131
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
University of Florida Jacksonville Healthcare, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Wolfson Children's Hospital, Shands Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Riley Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
University of Kentucky Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Louisana State University Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
University of Maryland Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Floating Hospital for Children at Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Minnesota Fairview University Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Kings County Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Brookdale University Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Neonatology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Westchester Medical Center - New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
University of North Carolina Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Levine Children's Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
WakeMed Faculty Neonatology
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
New Hanover Reginal Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Penn State Hershey Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Womens and Infant Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Carilion Roanoke Memorial Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
University of Alberta - Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
University of British Columbia - British Columbia Women's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
Manitoba Institute of Child Health
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3P 2C1
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Hospital Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
T3T 1C5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33902072
Citation
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.
Results Reference
derived

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Antibiotic Safety (SCAMP)

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