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Antibiotic Safety (SCAMP) (SCAMP)

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ClinicalTrials.gov Identifier: NCT01994993
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : February 27, 2018
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
The Emmes Company, LLC
Information provided by (Responsible Party):
Michael Cohen-Wolkowiez, Duke University

Tracking Information
First Submitted Date  ICMJE November 18, 2013
First Posted Date  ICMJE November 26, 2013
Results First Submitted Date  ICMJE January 15, 2018
Results First Posted Date  ICMJE February 27, 2018
Last Update Posted Date May 30, 2019
Study Start Date  ICMJE December 2013
Actual Primary Completion Date January 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2018)
Death [ Time Frame: Within 30 days after last dose of study drug, up to 40 days ]
Number of Participants who experienced Death
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
Death [ Time Frame: Within 30 days after last dose of study drug ]
Change History Complete list of historical versions of study NCT01994993 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
Number of Participants With Therapeutic Success at Day 30 [ Time Frame: 30 days after last dose of study drug ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
Number of Participants With Therapeutic Success at Day 30 and Day 90 [ Time Frame: 30 days and 90 days after last dose of study drug ]
Confirmed by 1).Alive and 2).Negative bacterial blood cultures
Current Other Pre-specified Outcome Measures
 (submitted: April 17, 2018)
  • Number of Participants With Feeding Intolerance [ Time Frame: 90 days after last dose of study drug ]
    Feeding intolerance confirmed by documentation of any feedings held for >24 consecutive hours in infants being fed
  • Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH) [ Time Frame: 90 days after last dose of study drug ]
    Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement Grade 4 IVH: Intraparenchymal hemorrhage
  • Number of Participants With Short Bowel Syndrome [ Time Frame: 90 days after last dose of study drug ]
    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
  • Number of Participants With Intestinal Perforation [ Time Frame: 90 days after last dose of study drug ]
    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
  • Number of Participants With Intestinal Stricture [ Time Frame: 90 days after last dose of study drug ]
    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
  • Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection [ Time Frame: 90 days after last dose of study drug ]
    Progression is determined by the clinical NEC scoring
  • Number of Participants With Gastrointestinal Surgeries [ Time Frame: 90 days after last dose of study drug ]
    Determined by medical history and confirmed with hospital records. (Laparotomy)
  • Number of Participants With Seizure [ Time Frame: 90 days after last dose of study drug ]
    documented seizure(s) in hospital records
  • Number of Participants With Positive Blood Cultures [ Time Frame: 90 days after last dose of study drug ]
    Positive blood culture (bacterial or fungal)
Original Other Pre-specified Outcome Measures
 (submitted: November 25, 2013)
  • Number of Participants With Feeding Intolerance [ Time Frame: 90 days after last dose of study drug ]
    Feeding intolerance confirmed by documentation of any feedings held for >24 consecutive hours in infants being fed
  • Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH) [ Time Frame: 90 days after last dose of study drug ]
    Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement Grade 4 IVH: Intraparenchymal hemorrhage
  • Number of Participants With Short Bowel Syndrome [ Time Frame: 90 days after last dose of study drug ]
    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
  • Number of Participants With Intestinal Perforation [ Time Frame: 90 days after last dose of study drug ]
    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
  • Number of Participants With Intestinal Stricture [ Time Frame: 90 days after last dose of study drug ]
    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
  • Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC) [ Time Frame: 90 days after last dose of study drug ]
    Progression is determined by the clinical NEC scoring
  • Number of Participants With Gastrointestinal Surgeries [ Time Frame: 90 days after last dose of study drug ]
    Determined by medical history and confirmed with hospital records.
 
Descriptive Information
Brief Title  ICMJE Antibiotic Safety (SCAMP)
Official Title  ICMJE Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Complicated Intra Abdominal Infections
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Active Comparator: Group 1 (ampicillin +gentamycin +metronidazole)
    Ampicillin and gentamycin and metronidazole
    Intervention: Drug: ampicillin and metronidazole and gentamicin
  • Active Comparator: Group 2 (ampicillin +gentamicin+clindamycin)
    ampicillin and gentamicin and clindamycin
    Intervention: Drug: ampicillin and gentamicin and clindamycin
  • Active Comparator: Group 3 (piperacillin-tazobactam and gentamicin)
    piperacillin-tazobactam and gentamicin
    Intervention: Drug: gentamicin and Piperacillin- tazobactam
  • Active Comparator: Group 4 (metronidazole)
    Per standard of care antibiotics, and Metronidazole
    Intervention: Drug: standard of care antibiotics and metronidazole
  • Active Comparator: Group 5 (metronidazole/clindamycin/piperacillin-tazobactam)
    metronidazole, clindamycin, or piperacillin-tazobactam
    Intervention: Drug: metronidazole, clindamycin, or piperacillin-tazobactam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2018)
260
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2013)
350
Actual Study Completion Date  ICMJE April 20, 2017
Actual Primary Completion Date January 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 120 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994993
Other Study ID Numbers  ICMJE Pro00048773
HHSN275201000003I ( Other Grant/Funding Number: NICHD )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Cohen-Wolkowiez, Duke University
Study Sponsor  ICMJE Michael Cohen-Wolkowiez
Collaborators  ICMJE The Emmes Company, LLC
Investigators  ICMJE
Principal Investigator: Micheal Cohen-Wolkowiez, MD, PhD Duke University
PRS Account Duke University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP