Evidence map›Paper›PMID 22955430›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012

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

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 and 20 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00621192 (Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants), which is not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
4.4field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00621192 phase1 / phase2completednot on this map

Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 Days) With Suspected or Complicated Intra-abdominal Infections

TypeinterventionalSponsorThe Emmes Company, LLCRan2008 to 2009Enrolled200ConditionsNecrotizing Enterocolitis, Intra-abdominal InfectionArmsmeropenem
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 66 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Creativity in Pediatric Clinical Pharmacology: Study Design and Oral Dosage Forms.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024
    Article
  6. Article
  7. Article
  8. The association of hypokalemia with meropenem administration: A case report and literature review.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2024
    Article
  9. Article
  10. Article
  11. Article
  12. Use of Antibiotics in Preterm Newborns.Antibiotics (Basel, Switzerland) · 2022
    Review
  13. Article
  14. Article
  15. Association between neonatal intensive care unit medication safety practices, adverse events, and death.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Article
  16. Article
  17. Article
  18. Cross-sectional study of drug utilisation in a Chinese neonatal unit.The Journal of international medical research · 2020
    Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

30 authors at 20 institutions in 1 country.

Michael Cohen-WolkowiezDepartment of Pediatrics, Duke University, Durham, North Carolina 27715, USA.
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
Meropenem Study Team
Clinical Research Institute · USUniversity of California, San Diego · USAkron Children's Hospital · USChildren's Hospital of Orange County · USChildren's Hospital of Philadelphia · USDoernbecher Children's Hospital · USDuke Medical Center · USDuke University · USDuke University Hospital · USEmmes (United States) · USGeorge Washington University · USPrimary Children's Hospital · USRiley Hospital for Children · USSharp Mary Birch Hospital for Women & Newborns · USState University of New York · USUniversity Hospitals of Cleveland · USUniversity of Alabama at Birmingham · USUniversity of Florida · USUniversity of Louisville · USUniversity of Michigan–Ann Arbor · US

Funding

UNIVERSITY OF UTAH CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCE-UL1: BPCAUL1RR025764 · NCRR · UNIVERSITY OF UTAH · PI MCCLAIN, DONALD A. · 2008 to 2011
$19.4M
UF Clinical and Translational Science AwardUL1TR000064 · NCATS · UNIVERSITY OF FLORIDA · PI NELSON, DAVID R · 2012 to 2014
$12.2M
Duke Research Training Program for PediatriciansT32HD043029 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2002 to 2017
$3.7M
Children's Center for Clinical Pharmacology StudiesU10HD031313 · NICHD · CHILDREN'S MERCY HOSP (KANSAS CITY, MO) · PI KEARNS, GREGORY LEE · 2004 to 2010
$3.0M
Prevention of Invasive Candidiasis: PK, Safety, and Neurodevelopmental OutcomesR01HD057956 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2008 to 2012
$2.8M
P450 Metabolism of Glucocorticoids in Lungs of Pediatric AsthmaticsR01HD060559 · NICHD · UNIVERSITY OF UTAH · PI REILLY, CHRISTOPHER A · 2010 to 2014
$2.3M
North Carolina Collaborative PPRU NetworkU10HD045962 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2004 to 2009
$2.1M
Center for Pediatric Clinical Pharmacology ResearchU10HD045934 · NICHD · UNIVERSITY OF LOUISVILLE · PI SULLIVAN, JANICE E · 2004 to 2009
$2.0M
Prevention of Invasive Candidiasis: PK, Safety, and Neurodevelopmental OutcomesR01FD003519 · FDA · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2008 to 2011
$1.6M
Metabolism and Toxicity of Acetaminophen in Preterm InfantsR01HD060543 · NICHD · CHILDREN'S RESEARCH INSTITUTE · PI VAN DEN ANKER, JOHANNES NICOLAAS · 2010 to 2014
$1.5M
Optimizing the Use of Morphine in Preterm InfantsR01HD048689 · NICHD · CHILDREN'S NATIONAL MEDICAL CENTER · PI VAN DEN ANKER, JOHANNES NICOLAAS · 2005 to 2009
$1.5M
Mentorship of early-career pediatricians in quantitiative methods and therapeuticK24HD058735 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2009 to 2018
$1.5M
FDA HHS 1R01FD003519-01FDA HHS R01 FD003519NCATS NIH HHS UL1 TR000064NCRR NIH HHS 3UL1RR025764-02S3NCRR NIH HHS UL1 RR025764NHLBI NIH HHS 1K23HL092225-01NICHD NIH HHS 1K23HD060040-01NICHD NIH HHS 1K23HD064814-01NICHD NIH HHS 1K24HD058735-01NICHD NIH HHS 1R01HD057956-02NICHD NIH HHS 1U10HD31313-16S1NICHD NIH HHS 1U10-HD45962-06NICHD NIH HHS 5R01HD048689NICHD NIH HHS 5R01HD060543NICHD NIH HHS 5 R01 HD060559-02NICHD NIH HHS 5T32HD043029-09NICHD NIH HHS HD060559-01NICHD NIH HHS HHSN267200700051CNICHD NIH HHS HHSN275200900012CNICHD NIH HHS K08 HD061607NICHD NIH HHS K08HD061607NICHD NIH HHS K23 HD060040NICHD NIH HHS K23 HD064814NICHD NIH HHS K23 HD068497NICHD NIH HHS K24 HD058735NICHD NIH HHS R00 HD056222NICHD NIH HHS R00HD056222NICHD NIH HHS R01 HD048689NICHD NIH HHS R01 HD057956NICHD NIH HHS R01 HD060543NICHD NIH HHS R01 HD060559NICHD NIH HHS T32 HD043029NICHD NIH HHS U10 HD031313NICHD NIH HHS U10 HD045934NICHD NIH HHS U10 HD045934 05NICHD NIH HHS U10 HD045962NIDA NIH HHS 5K24DA027992NIDA NIH HHS K24 DA027992PHS HHS 5U10045993
6 · The paper itself

Abstract

backgroundIntra-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.

methodsPreterm 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.

resultsOf 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%.

conclusionsMeropenem 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.

Indexed as

Anti-Bacterial AgentsCohort StudiesCritical IllnessFemaleHumansInfantInfant, NewbornIntraabdominal InfectionsMaleMeropenemThienamycinsAnti-Bacterial AgentsMeropenemThienamycins

Identifiers

PMID22955430
PMCPMC3491861
OpenAlexW2144210039

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.