Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections.

Publication Type
Journal Article
Year of Publication
Cohen-Wolkowiez, Michael; Poindexter, Brenda; Bidegain, Margarita; Weitkamp, Joern-Hendrik; Schelonka, Robert L; Randolph, David A; Ward, Robert M; Wade, Kelly; Valencia, Gloria; Burchfield, David; Arrieta, Antonio; Mehta, Varsha; Walsh, Michele; Kantak, Anand; Rasmussen, Maynard; Sullivan, Janice E; Finer, Neil; Rich, Wade; Brozanski, Beverly S; van den Anker, John; Blumer, Jeffrey; Laughon, Matthew; Watt, Kevin M; Kearns, Gregory L; Capparelli, Edmund V; Martz, Karen; Berezny, Katherine; Benjamin, Daniel K; Smith, P Brian; Meropenem Study Team
Clin Infect Dis
Date Published
2012 Dec
Anti-Bacterial Agents; Cohort Studies; Critical Illness; Female; Humans; Infant; Infant, Newborn; Intraabdominal Infections; Male; Meropenem; Thienamycins

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.