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

2012 Dec

Journal Article

Cohen-Wolkowiez, M.; Poindexter, B.; Bidegain, M.; Weitkamp, J.H.; Schelonka, R.L.; Randolph, D.A.; Ward, R.M.; Wade, K.; Valencia, G.; Burchfield, D.; Arrieta, A.; Mehta, V.; Walsh, M.; Kantak, A.; Rasmussen, M.; Sullivan, J.E.; Finer, N.; Rich, W.; Brozanski, B.S.; van den Anker, J.; Blumer, J.; Laughon, M.; Watt, K.M.; Kearns, G.L.; Capparelli, E.V.; Martz, K.; Berezny, K.; Benjamin, D.K.; Smith, B.

Clin Infect Dis






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.CLINICAL TRIALS REGISTRATION: NCT00621192.

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