Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections.
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.
Cohen-Wolkowiez, M; Poindexter, B; Bidegain, M; Weitkamp, J-H; 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, EV; Martz, K; Berezny, K; Benjamin, DK; Smith, PB; Meropenem Study Team,
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