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 and often fatal in premature infants. The most common cIAI in neonates is necrotizing enterocolitis (NEC), a devastating disease that causes inflammation and can eventually destroy the wall of the bowel.

“In extremely low-birth-weight infants, the death rate for NEC can be as high as 50 percent,” said Dr. Michael Smith, investigator for the SCAMP study and associate professor of pediatrics at the Duke University School of Medicine. “Even survivors can suffer from lifelong complications such as short bowel-syndrome and poor neurodevelopmental outcomes.”

The most commonly used antibiotics in infants with cIAI include ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, and gentamicin. However, since safety and efficacy data are lacking, these drugs are not labeled for use in infants with cIAI.

The PTN is filling this information gap with SCAMP, a partially randomized, multicenter, open-label study to determine the safety of these drug regimens in this specific and highly vulnerable population. Nearly 300 infants participated in the study at 58 sites in the U.S. and Canada. The infants were enrolled for 100 days, including 10 days of treatment and up to 90 days of follow-up assessments.

As a next step, the results of the SCAMP study will be submitted to the FDA for potential drug label changes.

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 safety and efficacy of antibiotics routinely used in infants with these life-threatening infections. Approximately 350 infants 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. To learn more about this study, visit clinicaltrials.gov.

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. If your site is interested in participating in the study, please contact Benjamin Lee at benjamin.lee@dm.duke.edu.