| Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections. | |
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MedLine Citation:
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PMID: 22955430 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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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:
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Type: Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't Date: 2012-09-05 |
Journal Detail:
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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:
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Created Date: 2012-11-08 Completed Date: 2013-04-16 Revised Date: 2013-05-13 |
Medline Journal Info:
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Nlm Unique ID: 9203213 Medline TA: Clin Infect Dis Country: United States |
Other Details:
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Languages: eng Pagination: 1495-502 Citation Subset: IM |
Affiliation:
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Department of Pediatrics, Duke University, Durham, North Carolina 27715, USA. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00621192 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Anti-Bacterial Agents
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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:
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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; 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:
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0/Anti-Bacterial Agents; 0/Thienamycins; 96036-03-2/meropenem |
| Comments/Corrections | |
Comment In:
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Clin Infect Dis. 2012 Dec;55(11):1503-4
[PMID:
22955433
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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