Meropenem is a broad-spectrum anti-microbial drug used to treat intra-abdominal infections in young infants. Intra-abdominal infections are common in premature infants younger than three months of age and are often fatal. Meropenem, which effectively treats many types of bacterial infections, is approved for use in adults and older children and has long been prescribed for infants younger than three months despite a lack of data about the effects of the drug on these patients.
Brian Smith, MD, MPH, MHS, of the Duke Clinical Research Institute, presents the NICHD/BPCA meropenem study.
The purpose of the meropenem study, which ran from 2008 to 2011, was to determine the optimal dosing regimen for meropenem in infants younger than 90 days old. Researchers were also interested in determining how safe the drug is for very young infants, especially when compared with imipenem, another broad-spectrum anti-microbial drug closely related to meropenem.
“Seizures are a known side effect [of imipenem], so we were particularly interested in looking to see if seizures were an adverse event we would see in this trial,” Smith said.
Testing young children presented certain challenges to researchers. Infants cannot provide biological specimens in the quantities that adults can. Only recently, Smith said, has medical technology allowed researchers to conduct studies using minute amounts of blood and other specimens.
“The blood samples that we used to measure the meropenem were very small,” he said. “They were 200 microliters, which is one-twenty-fifth of a teaspoon. We now have techniques that can measure concentrations of drugs in very small samples that weren’t available 20 or 30 years ago.”
The trial comprised 200 infants at 24 neonatal intensive care units across the United States. Each patient was given a dose of meropenem based on his or her gestational age at the time of birth and postnatal age at the time of the study. Researchers acquired blood samples from each infant when blood was being sampled as part of the children’s regular care.
Their findings suggested that meropenem as dosed in the study is a safe alternative for young infants with intra-abdominal infections. With this information in hand, researchers suggested new labeling guidelines to the Food and Drug Administration, which were implemented in March 2015.
- Adverse events associated with meropenem versus imipenem/cilastatin therapy in a large retrospective cohort of hospitalized infants The Pediatric Infectious Disease Journal • July 2013. Hornik CP, Herring AH, Benjamin DK Jr, Capparelli EV, Kearns GL, van den Anker J, Cohen-Wolkowiez M, Clark RH, Smith PB; Best Pharmaceuticals for Children Act-Pediatric Trials Network. Carbapenems are commonly used in hospitalized infants despite a lack of complete safety data and associations with seizures in older children. We ...
- Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections Clinical Infectious Disease • December 2012. Cohen-Wolkowiez M, Poindexter B, Bidegain M, Weitkamp JH, Schelonka RL, Randolph DA, Ward RM, Wade K, Valencia G, Burchfield D, Arrieta A, Mehta V, Walsh M, Kantak A, Rasmussen M, Sullivan JE, Finer N, Rich W, Brozanski BS, van den Anker J, Blumer J, Laughon M, Watt KM, Kearns GL, Capparelli ...
- Population pharmacokinetics of meropenem in plasma and cerebrospinal fluid of infants with suspected or complicated intra-abdominal infections The Pediatric Infectious Disease Journal • October 2011. Smith PB, Cohen-Wolkowiez M, Castro LM, Poindexter B, Bidegain M, Weitkamp JH, Schelonka RL, Ward RM, Wade K, Valencia G, Burchfield D, Arrieta A, Bhatt-Mehta V, Walsh M, Kantak A, Rasmussen M, Sullivan JE, Finer N, Brozanski BS, Sanchez P, van den Anker J, Blumer J, Kearns GL, Capparelli ...
Principal Investigators: P. Brian Smith, MD, MPH, MHS and Daniel K. Benjamin, MD, PhD, MPH
Duke Health, Durham, NC
- PTN meropenem study published in the Federal Register The PTN marks another milestone as the Food and Drug Administration (FDA) has published a summary report of its pediatric study of meropenem in the Federal Register. Meropenem is a broad-spectrum anti-microbial drug often used to treat intra-abdominal infections in infants. The purpose of the PTN study, which began in the summer of 2008, was to ...
- Meropenem label changed to reflect PTN findings The FDA recently changed the label for the drug meropenem to reflect findings from a study conducted by PTN investigators. Results from the study were published in the Pediatric Infectious Disease Journal.
- PTN shares meropenem study data To help improve the knowledge base for pediatric medicine, the PTN is pleased to share data from its meropenem study with interested investigators. Information about the study and how to obtain the data is available on the website.
- The Institute of Medicine releases report on pediatric studies conducted under BPCA and PREA The Institute of Medicine (IOM) released a report today that finds that federal laws motivating or requiring drugmakers to conduct pediatric studies have yielded important information to guide the use of medications in children. Titled “Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity ...
- The PTN provides insights and updates at the 2012 BPCA annual meeting On December 4, 2012, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) staged the 2012 Best Pharmaceuticals for Children Act (BPCA) Annual Meeting in Rockville, MD. This yearly event serves as part of the NICHD mandate to oversee a priority list of needs in pediatric therapeutics under the BPCA. The BPCA ...
- 2011 BPCA Priority List of Pediatric Therapeutic Needs released The 2011 BPCA Priority List of Pediatric Therapeutic Needs and the 2011 BPCA Priority List of Pediatric Therapeutic Needs under Consideration was released on April 1, 2011. Please refer to the Federal Register Notice for additional details.