Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections.
2012 Dec
Journal Article
Authors:
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.
Secondary:
Clin Infect Dis
Volume:
55
Pagination:
1495-502
Issue:
11
PMID:
22955430
Keywords:
Anti-Bacterial Agents; Cohort Studies; Critical Illness; Female; Humans; Infant; Infant, Newborn; Intraabdominal Infections; Male; Meropenem; Thienamycins
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.
