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.