Antibiotic Safety (SCAMP)

Complicated Intra Abdominal Infections Clinical Trial

— SCAMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994993
• Other study ID #: Pro00048773
• Secondary ID: HHSN275201000003
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2013
• Est. completion date: April 20, 2017

Study information

• Verified date: May 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: April 20, 2017
• Est. primary completion date: January 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Days

Eligibility

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.

Related Conditions & MeSH terms

• Complicated Intra Abdominal Infections
• Infection
• Intraabdominal Infections

Intervention

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)
• 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)
• 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)
• 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)
• 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)

Locations

Country	Name	City	State
Canada	University of Alberta - Royal Alexandra Hospital	Edmonton	Alberta
Canada	Hospital Sainte-Justine	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	University of British Columbia - British Columbia Women's Hospital	Vancouver	British Columbia
Canada	Manitoba Institute of Child Health	Winnipeg	Manitoba
United States	Georgia Regents University	Augusta	Georgia
United States	University of Maryland Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Floating Hospital for Children at Tufts Medical Center	Boston	Massachusetts
United States	Brookdale University Hospital	Brooklyn	New York
United States	Kings County Hospital	Brooklyn	New York
United States	University of North Carolina Hospital	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Levine Children's Hospital	Charlotte	North Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	East Carolina University	Greenville	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Penn State Hershey Children's Hospital	Hershey	Pennsylvania
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Texas Children's Hospital	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Riley Hospital	Indianapolis	Indiana
United States	University of Florida Jacksonville Healthcare, Inc.	Jacksonville	Florida
United States	Wolfson Children's Hospital, Shands Medical Center	Jacksonville	Florida
United States	University of Kentucky Hospital	Lexington	Kentucky
United States	Arkansas Children's Hospital/Univ of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Loma Linda University Medical Center	Loma Linda	California
United States	University of Minnesota Fairview University Medical Center	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Columbia University Neonatology	New York	New York
United States	New York University School of Medicine	New York	New York
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	Stanford University School of Medicine	Palo Alto	California
United States	Womens and Infant Hospital of Rhode Island	Providence	Rhode Island
United States	WakeMed Faculty Neonatology	Raleigh	North Carolina
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	Intermountain Medical Center	Salt Lake City	Utah
United States	University of Utah	Salt Lake City	Utah
United States	Rady Children's Hospital and Health Center	San Diego	California
United States	Sharp Mary Birch	San Diego	California
United States	University of California San Diego Medical Center	San Diego	California
United States	Louisana State University Health Sciences Center	Shreveport	Louisiana
United States	Westchester Medical Center - New York Medical College	Valhalla	New York
United States	Wesley Medical Center	Wichita	Kansas
United States	New Hanover Reginal Medical Center	Wilmington	North Carolina
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Michael Cohen-Wolkowiez	The Emmes Company, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Feeding Intolerance	Feeding intolerance confirmed by documentation of any feedings held for >24 consecutive hours in infants being fed	90 days after last dose of study drug
Other	Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH)	Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement; Grade 4 IVH: Intraparenchymal hemorrhage	90 days after last dose of study drug
Other	Number of Participants With Short Bowel Syndrome	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	90 days after last dose of study drug
Other	Number of Participants With Intestinal Perforation	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	90 days after last dose of study drug
Other	Number of Participants With Intestinal Stricture	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	90 days after last dose of study drug
Other	Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection	Progression is determined by the clinical NEC scoring	90 days after last dose of study drug
Other	Number of Participants With Gastrointestinal Surgeries	Determined by medical history and confirmed with hospital records. (Laparotomy)	90 days after last dose of study drug
Other	Number of Participants With Seizure	documented seizure(s) in hospital records	90 days after last dose of study drug
Other	Number of Participants With Positive Blood Cultures	Positive blood culture (bacterial or fungal)	90 days after last dose of study drug
Primary	Death	Number of Participants who experienced Death	Within 30 days after last dose of study drug, up to 40 days
Secondary	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	30 days after last dose of study drug