Clinical trial NCT01994993: Antibiotic Safety (SCAMP)
Official title: Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Complicated Intra Abdominal Infections
Keywords: Antibiotics
ampicillin
metronidazole
clindamycin
piperacillin-tazobactam
Safety
Infants
Intra abdominal infections
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The Emmes Company, LLC
First posted: 2013-11-26
Enrollment: 260
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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/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.

Primary outcomes:
measure: Death
timeFrame: Within 30 days after last dose of study drug, up to 40 days
Secondary outcomes:
measure: Number of Participants With Therapeutic Success at Day 30
timeFrame: 30 days after last dose of study drug
Other outcomes:
measure: Number of Participants With Feeding Intolerance
timeFrame: 90 days after last dose of study drug
measure: Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH)
timeFrame: 90 days after last dose of study drug
measure: Number of Participants With Short Bowel Syndrome
timeFrame: 90 days after last dose of study drug
measure: Number of Participants With Intestinal Perforation
timeFrame: 90 days after last dose of study drug
measure: Number of Participants With Intestinal Stricture
timeFrame: 90 days after last dose of study drug
measure: Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection
timeFrame: 90 days after last dose of study drug
measure: Number of Participants With Gastrointestinal Surgeries
timeFrame: 90 days after last dose of study drug
measure: Number of Participants With Seizure
timeFrame: 90 days after last dose of study drug
measure: Number of Participants With Positive Blood Cultures
timeFrame: 90 days after last dose of study drug
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Children's Hospital/Univ of Arkansas for Medical Sciences
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital and Health Center
state: California
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Mary Birch
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Jacksonville
country: United States
facility: University of Florida Jacksonville Healthcare, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Wolfson Children's Hospital, Shands Medical Center
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Indianapolis
country: United States
facility: Riley Hospital
state: Indiana
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Hospital
state: Kentucky
city: Shreveport
country: United States
facility: Louisana State University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Hospital
state: Maryland
city: Boston
country: United States
facility: Floating Hospital for Children at Tufts Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Fairview University Medical Center
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Brooklyn
country: United States
facility: Kings County Hospital
state: New York
city: Brooklyn
country: United States
facility: Brookdale University Hospital
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Neonatology
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center - New York Medical College
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Levine Children's Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Faculty Neonatology
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Reginal Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Cleveland
country: United States
facility: Rainbow Babies and Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Hershey Children's Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Womens and Infant Hospital of Rhode Island
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Edmonton
country: Canada
facility: University of Alberta - Royal Alexandra Hospital
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia - British Columbia Women's Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Institute of Child Health
state: Manitoba
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Montreal
country: Canada
facility: Hospital Sainte-Justine
state: Quebec
Study officials:
affiliation: Duke University
name: Micheal Cohen-Wolkowiez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.