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

Assessing the safety, efficacy, and pharmacokinetics of a multidrug antibiotic regimen (clindamycin, ampicillin, metronidazole, and piperacillin-tazobactam) for infants with complicated intra-abdominal infections.

Summary

Complicated intra-abdominal infections are common and often fatal in premature infants. These infections often occur as a result of necrotizing enterocolitis (NEC), the pathogenesis of which involves intestinal mucosal injury, usually associated with intestinal ischemia and bacterial overgrowth. NEC has a high overall mortality (15%) and, in extremely-low-birth-weight infants (≤1000 grams), mortality for surgical NEC is nearly 50%. Survivors often suffer from complications, including stricture formation, and life-long morbidities such as short bowel syndrome. Infants who have had NEC are also at increased risk of poor neurodevelopmental outcomes.

Recommended antibiotics for complicated intra-abdominal infections in infants include combinations of ampicillin, piperacillin-tazobactam, meropenem, metronidazole, clindamycin, or gentamicin. In spite of their frequent use, however, the safety and efficacy of these antibiotics in infants with complicated intra-abdominal infections have not been established.

The PTN is seeking to fill this information gap with SCAMP, a partially-randomized, multicenter, open-label Safety study of Clindamycin, Ampicillin, Metronidazole, and Piperacillin-tazobactam in infants with complicated intra-abdominal infections. The primary objective of this study is to determine the safety of these drug regimens in this specialized context; secondary objectives include determining the drugs’ effectiveness, their pharmacokinetics in this unique population, biomarker association with disease severity and antibiotic exposure, and diversity or shift of intestinal microbiota. Approximately 284 infants, <3 months of age will be enrolled at approximately 50 sites. Total length of study participation is 100 days, including 10 days of treatment and up to 90 days of follow-up assessments.

Publications

  • Use of Population Pharmacokinetics and Electronic Health Records to Assess Piperacillin-Tazobactam Safety in Infants The Pediatric Infectious Disease Journal • September 2017. Salerno S, Hornik CP, Cohen-Wolkowiez M, Smith PB, Ku LC, Kelly MS, Clark R, Gonzalez D; Best Pharmaceuticals for Children Act–Pediatric Trials Network Steering Committee. Piperacillin, in combination with tazobactam, is frequently used in infants for treating nosocomial infections, although safety data in this population are limited. Electronic health ...
  • Intestinal Fatty-Acid Binding Protein and Metronidazole Response in Premature Infants Journal of Neonatal and Perinatal Medicine • November 2014. Sampson MR, Bloom BT, Arrieta A, Capparelli E, Benjamin DK Jr, Smith PB, Kearns GL, van den Anker J, Cohen-Wolkowiez M. In premature infants with suspected intra-abdominal infection, biomarkers for treatment response to antimicrobial therapy are lacking. Intestinal fatty acid-binding protein (I-FABP) is specific to the enterocyte and is ...

OVERVIEW

Status:
Ongoing

ClinicalTrials.gov identifier:
NCT01994993

Principal Investigator:
Michael Cohen-Wolkowiez, MD, PhD
Duke Health, Durham, NC

NEWS

  • Database locked for SCAMP study The Pediatric Trials Network (PTN) has locked the database for the Antibiotic Safety in Infants with Complicated Intra-abdominal Infections (SCAMP) study. The study, which enrolled its first patient in 2014, is designed to assess the safety, efficacy, and pharmacokinetics of three commonly prescribed antibiotic regimens for infants with intra-abdominal infections. Complicated intra-abdominal infections (cIAIs) are common ...
  • SCAMP Enrollment is Wrapping Up Two years ago, the study site at the University of Florida–Jacksonville Shands Medical Centerwe enrolled SCAMP’s first patient. With remarkable effort from more than 50 study sites, including 5 in Canada, SCAMP will close enrollment by the end of 2016. Once the enrollment period ends, the study team will analyze the data and submit the clinical study report.
  • SCAMP enrolls its first patient SCAMP—a randomized, multicenter, open-label Safety study of Clindamycin, Ampicillin, Metronidazole, and Piperacillin-tazobactam in infants with complicated intra-abdominal infections—enrolled its first patient over the weekend. The research team at the University of Florida–Jacksonville Shands Medical Center did the honors, led by site principal investigator Mark Hudak and study coordinator Renee Prince. SCAMP is seeking to determine the ...
  • SCAMP takes off SCAMP is taking off. A randomized, multicenter, open-label safety study of clindamycin, ampicillin, metronidazole, and piperacillin-tazobactam in infants with complicated intra-abdominal infections, SCAMP held its first investigator meeting on 2/28/2014. Twenty-five sites have been selected to date, with an additional 25 sites in the U.S. still to be recruited. To learn more about SCAMP, visit clinicaltrials.gov. ...