Carbapenem-resistant Klebsiella pneumoniae colonization in pediatric and neonatal intensive care units: risk factors for progression to infection

Aktürk, Hacer; Sütçü, Murat; Somer, Ayper; Aydın, Derya; Cihan, Rukiye; Özdemir, Aslı; Çoban, Asuman; İnce, Zeynep; Çıtak, Agop; Salman, Nuran

doi:10.1016/j.bjid.2015.12.004

Cited by 76 publications

(63 citation statements)

References 25 publications

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“…In contrast to previous studies, we did not find an association between carbapenem use and CRGNO colonization [25-27]. Of note, our study was an RCT with strict inclusion criteria, in contrast to previous retrospective and/or observational studies which included all patients without restriction [25, 27, 28].…”

Section: Resultscontrasting

confidence: 84%

Meropenem vs standard of care for treatment of neonatal late onset sepsis (NeoMero1): a randomised controlled trial

Lutsar

Chazallon

Trafojer

et al. 2018

Preprint

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BackgroundThe early use of broad-spectrum antibiotics remains the cornerstone for the treatment of neonatal late onset sepsis (LOS). However, which antibiotics should be used is still debatable, as relevant studies were conducted more than 20 years ago, were single centre or country, insufficiently powered, evaluated antibiotics not in clinical use anymore and had variable inclusion/exclusion criteria and outcome measures. Moreover, antibiotic-resistant bacteria have become a major problem in many countries worldwide. We hypothesized that efficacy of meropenem as a broad spectrum antibiotic is superior to standard of care regimen (SOC) in empiric treatment of LOS and thus aimed to compare the efficacy and safety of meropenem to SOC in infants aged <90 days with LOS.Methods and findingsNeoMero-1 was a randomized, open-label, phase III superiority trial conducted in 18 neonatal units in 6 countries. Infants with post-menstrual age (PMA) of ≤44 weeks with positive blood culture and one, or those with negative culture and at least with two predefined clinical and laboratory signs suggestive of LOS, or those with PMA >44 weeks meeting the Goldstein criteria of sepsis, were randomized in a 1:1 ratio to receive meropenem or SOC (ampicillin+gentamicin or cefotaxime+gentamicin) for 8-14 days. The primary outcome was treatment success (survival, no modification of allocated therapy, resolution/improvement of clinical and laboratory markers, no need of additional antibiotics and presumed/confirmed eradication of pathogens) at test-of-cure visit (TOC) in full analysis set. Stool samples were tested at baseline and day 28 for meropenem-resistant Gram-negative organisms (CRGNO).The primary analysis was performed in all randomised patients (full analysis set) and in patients with culture confirmed LOS. Proportions of participants with successful outcome were compared by using a logistic regression model adjusted for the stratification factors.From September 3rd 2012 to November 30th 2014, in total 136 patients in each arm were randomized; 140 (52%) were culture positive. Success at TOC was achieved in 44/136 (32%) in the meropenem arm vs. 31/135 (23%) in the SOC arm (p=0.087); 17/63 (27%) vs. 10/77 (13%) in patients with positive cultures (p=0.022). The main reason of failure was modification of allocated therapy. Adverse events occurred in 72% and serious adverse events in 17% of patients, the mortality rate was 6% with no differences between study arms. Cumulative acquisition of CRGNO by day 28 occurred in 4% in the meropenem and 12% in the SOC arm (p=0.052).ConclusionsMeropenem was not superior to SOC in terms of success at TOC, short term hearing disturbances, safety or mortality and did not outselect colonization with CRGNOs. Meropenem as broad-spectrum antibiotic should be reserved for neonates who are more likely to have Gram-negative LOS, especially in NICUs where microorganisms producing ESBL and AmpC beta-lactamases are circulating.

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Section: Resultscontrasting

confidence: 84%

Meropenem vs standard of care for treatment of neonatal late onset sepsis (NeoMero1): a randomised controlled trial

Lutsar

Chazallon

Trafojer

et al. 2018

Preprint

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show abstract

“…In contrast to previous studies, we did not find an association between carbapenem use and CRGNO colonization [25][26][27]. Of note, our study was an RCT with strict inclusion criteria, in contrast to previous retrospective and/or observational studies, which included all patients without restriction [25,27,28].…”

Section: Plos Onecontrasting

confidence: 86%

Meropenem vs standard of care for treatment of neonatal late onset sepsis (NeoMero1): A randomised controlled trial

et al. 2020

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“…8 The prevalence of CRE carriage in a study in Turkey was 2.6% among NICU patients and 3.6% among PICU patients. 9 Subsequent infection with CRE organisms occurred in 18% of colonized NICU patients and 39% of pediatric intensive care units (PICU) patients, with a 16.5% mortality rate.…”

Section: Resultsmentioning

confidence: 99%

Perirectal Screening for Carbapenem-Resistant Enterobacteriaceae Obtained From 100 Consecutive Healthy Pregnant Women in Labor at a Brooklyn Hospital: Results and Risk Factors

Rawstron

Jackman

Serebro

et al. 2018

Infect. Control Hosp. Epidemiol.

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Carbapenem-resistant Klebsiella pneumoniae colonization in pediatric and neonatal intensive care units: risk factors for progression to infection

Cited by 76 publications

References 25 publications

Meropenem vs standard of care for treatment of neonatal late onset sepsis (NeoMero1): a randomised controlled trial

Meropenem vs standard of care for treatment of neonatal late onset sepsis (NeoMero1): a randomised controlled trial

Meropenem vs standard of care for treatment of neonatal late onset sepsis (NeoMero1): A randomised controlled trial

Perirectal Screening for Carbapenem-Resistant Enterobacteriaceae Obtained From 100 Consecutive Healthy Pregnant Women in Labor at a Brooklyn Hospital: Results and Risk Factors

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