Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections
Michael Cohen-Wolkowiez, Brenda Poindexter, Margarita Bidegain, Joern-Hendrik Weitkamp, Robert L Schelonka, David A Randolph, Robert M Ward, Kelly Wade, Gloria Valencia, David Burchfield, Antonio Arrieta, Varsha Mehta, Michele Walsh, Anand Kantak, Maynard Rasmussen, Janice E Sullivan, Neil Finer, Wade Rich, Beverly S Brozanski, John van den Anker, Jeffrey Blumer, Matthew Laughon, Kevin M Watt, Gregory L Kearns, Edmund V Capparelli, Karen Martz, Katherine Berezny, Daniel K Benjamin Jr, P Brian Smith, Meropenem Study Team, Michael Cohen-Wolkowiez, Brenda Poindexter, Margarita Bidegain, Joern-Hendrik Weitkamp, Robert L Schelonka, David A Randolph, Robert M Ward, Kelly Wade, Gloria Valencia, David Burchfield, Antonio Arrieta, Varsha Mehta, Michele Walsh, Anand Kantak, Maynard Rasmussen, Janice E Sullivan, Neil Finer, Wade Rich, Beverly S Brozanski, John van den Anker, Jeffrey Blumer, Matthew Laughon, Kevin M Watt, Gregory L Kearns, Edmund V Capparelli, Karen Martz, Katherine Berezny, Daniel K Benjamin Jr, P Brian Smith, Meropenem Study Team
Abstract
Background: Intra-abdominal infections are common in young infants and lead to significant morbidity and mortality. Meropenem is a broad-spectrum antimicrobial with excellent activity against pathogens associated with intra-abdominal infections. The purpose of this study was to determine the safety and effectiveness of meropenem in young infants with suspected or complicated intra-abdominal infections.
Methods: Preterm and term infants <91 days of age with suspected or confirmed intra-abdominal infections hospitalized in 24 neonatal intensive care units were studied in an open-label, multiple-dose study. Adverse events and serious adverse events were collected through 3 and 30 days following the last meropenem dose, respectively. Effectiveness was assessed by 3 criteria: death, bacterial cultures, and presumptive clinical cure score.
Results: Of 200 subjects enrolled in the study, 99 (50%) experienced an adverse event, and 34 (17%) had serious adverse events; no adverse events were probably or definitely related to meropenem. The most commonly reported adverse events were sepsis (6%), seizures (5%), elevated conjugated bilirubin (5%), and hypokalemia (5%). Only 2 of the serious adverse events were determined to be possibly related to meropenem (isolated ileal perforation and an episode of fungal sepsis). Effectiveness was evaluable in 192 (96%) subjects, and overall treatment success was 84%.
Conclusions: Meropenem was well tolerated in this cohort of critically ill infants, and the majority of infants treated with meropenem met the definition of therapeutic success.
Clinical trials registration: NCT00621192.
Source: PubMed