Document Detail


Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections.
MedLine Citation:
PMID:  22955430     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Michael Cohen-Wolkowiez; Brenda Poindexter; Margarita Bidegain; Joern-Hendrik Weitkamp; Robert L Schelonka; David A Randolph; Robert M Ward; Kelly Wade; Gloria Valencia; David Burchfield; Antonio Arrieta; Varsha Mehta; Michele Walsh; Anand Kantak; Maynard Rasmussen; Janice E Sullivan; Neil Finer; Wade Rich; Beverly S Brozanski; John van den Anker; Jeffrey Blumer; Matthew Laughon; Kevin M Watt; Gregory L Kearns; Edmund V Capparelli; Karen Martz; Katherine Berezny; Daniel K Benjamin; P Brian Smith;
Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2012-09-05
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  55     ISSN:  1537-6591     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-08     Completed Date:  2013-04-16     Revised Date:  2014-07-31    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1495-502     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00621192
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MeSH Terms
Descriptor/Qualifier:
Anti-Bacterial Agents / administration & dosage,  adverse effects,  pharmacokinetics,  therapeutic use*
Cohort Studies
Critical Illness
Female
Humans
Infant
Infant, Newborn
Intraabdominal Infections / drug therapy*,  pathology
Male
Thienamycins / administration & dosage,  adverse effects,  pharmacokinetics,  therapeutic use*
Grant Support
ID/Acronym/Agency:
1K23HD060040-01/HD/NICHD NIH HHS; 1K23HD064814-01/HD/NICHD NIH HHS; 1K23HL092225-01/HL/NHLBI NIH HHS; 1K24HD058735-01/HD/NICHD NIH HHS; 1R01FD003519-01/FD/FDA HHS; 1R01HD057956-02/HD/NICHD NIH HHS; 1U10-HD45962-06/HD/NICHD NIH HHS; 1U10HD31313-16S1/HD/NICHD NIH HHS; 3UL1RR025764-02S3/RR/NCRR NIH HHS; 5 R01 HD060559-02/HD/NICHD NIH HHS; 5K24DA027992/DA/NIDA NIH HHS; 5R01HD048689/HD/NICHD NIH HHS; 5R01HD060543/HD/NICHD NIH HHS; 5T32HD043029-09/HD/NICHD NIH HHS; 5U10045993//PHS HHS; HD060559-01/HD/NICHD NIH HHS; K08 HD061607/HD/NICHD NIH HHS; K08HD061607/HD/NICHD NIH HHS; K23 HD068497/HD/NICHD NIH HHS; K24 HD058735/HD/NICHD NIH HHS; R00HD056222/HD/NICHD NIH HHS; U10 HD045934 05/HD/NICHD NIH HHS; UL1 TR000064/TR/NCATS NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/Thienamycins; 96036-03-2/meropenem
Comments/Corrections
Comment In:
Clin Infect Dis. 2012 Dec;55(11):1503-4   [PMID:  22955433 ]

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