title: Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections.
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.
  
  
  BACKGROUND
  NCT00621192.
authors.affiliation: Department of Pediatrics, Duke University, Durham, North Carolina 27715, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Cohen-Wolkowiez
authors.forename: Brenda
authors.initials: B
authors.lastname: Poindexter
authors.forename: Margarita
authors.initials: M
authors.lastname: Bidegain
authors.forename: Joern-Hendrik
authors.initials: JH
authors.lastname: Weitkamp
authors.forename: Robert L
authors.initials: RL
authors.lastname: Schelonka
authors.forename: David A
authors.initials: DA
authors.lastname: Randolph
authors.forename: Robert M
authors.initials: RM
authors.lastname: Ward
authors.forename: Kelly
authors.initials: K
authors.lastname: Wade
authors.forename: Gloria
authors.initials: G
authors.lastname: Valencia
authors.forename: David
authors.initials: D
authors.lastname: Burchfield
authors.forename: Antonio
authors.initials: A
authors.lastname: Arrieta
authors.forename: Varsha
authors.initials: V
authors.lastname: Mehta
authors.forename: Michele
authors.initials: M
authors.lastname: Walsh
authors.forename: Anand
authors.initials: A
authors.lastname: Kantak
authors.forename: Maynard
authors.initials: M
authors.lastname: Rasmussen
authors.forename: Janice E
authors.initials: JE
authors.lastname: Sullivan
authors.forename: Neil
authors.initials: N
authors.lastname: Finer
authors.forename: Wade
authors.initials: W
authors.lastname: Rich
authors.forename: Beverly S
authors.initials: BS
authors.lastname: Brozanski
authors.forename: John
authors.initials: J
authors.lastname: van den Anker
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Blumer
authors.forename: Matthew
authors.initials: M
authors.lastname: Laughon
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Watt
authors.forename: Gregory L
authors.initials: GL
authors.lastname: Kearns
authors.forename: Edmund V
authors.initials: EV
authors.lastname: Capparelli
authors.forename: Karen
authors.initials: K
authors.lastname: Martz
authors.forename: Katherine
authors.initials: K
authors.lastname: Berezny
authors.forename: Daniel K
authors.initials: DK
authors.lastname: Benjamin
authors.forename: P Brian
authors.initials: PB
authors.lastname: Smith
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D015331:Cohort Studies; D016638:Critical Illness; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D059413:Intraabdominal Infections / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D000077731:Meropenem; D013845:Thienamycins / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D013845:Thienamycins; D000077731:Meropenem