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Cronobacter Position Statement Working Group 2023

This workspace is for the working group drafting a CSTE position statement to recommend a standardized surveillance case definition and/or recommend national notifiability for invasive Cronobacter sakazakii infections in infants.
Joe CoyleMary-Margaret Fill, TNMeredith Lichtenstein, CSTEShannon McBeeMegin NicholsStephanie Black, ChicagoKirsten LarsonKirk SmithJohn DunnAnnastasia GrossSarah Lyon-CalloJennifer ReadCarl WilliamsAnn ThomasLaura Tourdot +29 others
Posted by Shannon McBee ·

Position Statement Input

The writing subgroup is looking for the larger group input on some some key points. Please feel free to submit your recommendation and rationale on the following questions:
  1.  Who should be the target population for Cronobacter surveillance? 
  2.   What Cronobacter cases do you think should be reportable, invasive or all?
  3.   Should Cronobacter be a nationally notifiable condition?

Comments & Events

Josh Rounds, Minnesota Department of Health Josh Rounds
1)    Infants under 1 year of age, particularly if the main purpose of this surveillance is to be able identify contaminated powdered infant formula.

2)    I’d lean towards invasive only. 
  • Should we be more specific to just blood and CSF? Are there other invasive specimen sources that Cronobacter is isolated from? Maybe CDC SMEs can weight in?
  • We include non-invasive in our reporting rules in MN and we do infrequently get non-invasive cases reported to us. They’ve been difficult to investigate as they are often asymptomatic (so possibly just colonized with Cronobacter which makes identifying the correct exposure time period challenging) or test positive for other pathogens at the same time. We’ve also had 3 cases where the specimen source was a tracheal aspirate. We’ve treated these differently than the other non-invasive sources as they are usual from an intubated child whose exposure we often suspect occurred in the hospital (often a PICU) so wanted to at least have our healthcare-associated infections staff talk to the hospital care team.
  • The benefit of including non-invasive cases would be to get additional isolates to sequence.
3)    Yes
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Shari Shea, APHL Shari Shea
I've been in meetings in various settings over the past 6 months where calls were strong for making these infections nationally notifiable, from state regulatory and laboratory staff to FDA leadership. While the details of such a position need to be worked out by this group of SMEs and with CSTE, are there arguments against making the condition (in some defined instances) notifiable?
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Delaney Moore, Utah Department of Health and Human Services Delaney Moore
  1. Infants under age 1, especially if our main goal is detecting formula driven outbreaks.
  2. Invasive only
  3. Yes
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Hillary Spencer Hillary Spencer
1. Infants under 1 year (in addition to formula associated outbreaks, breastmilk can be contaminated and theoretically there could be a common environmental source in a congregate setting such as a NICU though I think breastmilk-associated cases reported to date have been sporadic.  I was intrigued by the 2014 Patrick paper which described infection/colonization in particularly in older adults but I'm not aware of a public health action that would stem from surveillance in older adults)
2. Invasive disease - isolates from sterile sites, or clinical disease with isolate from non-sterile site and no alternative etiology, or clinical disease with epi link (e.g. consumed formula from contaminated lot, in a NICU with a known outbreak) an no alternative etiology
3. yes - without wide adoption, it will remain difficult to detect trends and outbreaks in this rare disease
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Julia Haston, CDC Julia Haston
These are great thoughts from the group! Responding to Joshua Rounds's comment, 
  • Should we be more specific to just blood and CSF? Are there other invasive specimen sources that Cronobacter is isolated from? Maybe CDC SMEs can weight in?
During the 2022 Cronobacter investigation, we limited our case definition to blood and CSF only among infants <12 months of age. There are some reports of Cronobacter causing necrotizing enterocolitis in neonates/young infants, though this relationship has not been definitively established. Depending on how "invasive" is defined, NEC cases could meet those criteria. Also, we have received some reports of UTIs in neonates/young infants that have been attributed to Cronobacter. I'm still unclear on the pathophysiology (e.g., how is the Cronobacter getting in the urinary tract? Is it translocating from the gut? Colonizing the stool, then contaminating the urethra due to stool in the diaper? Is it colonizing NICUs?). While not usually considered "invasive", UTIs can be quite severe in neonates. However, if the patient did have a severe UTI and developed urosepsis, this would presumably be captured in the blood culture criteria. The Patrick 2014 paper describes 13.6% of infant specimens coming from urine. Regarding stool and respiratory specimens, Cronobacter is thought to have been a colonizer in most situations I'm aware of. There is no clear consensus of Cronobacter causing respiratory or GI illness (besides NEC) in infants. 
All that to say, we chose to include only blood and CSF. We could not find enough definitive evidence associating disease with organism detection to support the inclusion of other specimen sites. 
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Lavin Joseph, CDC Lavin Joseph
Thank you all for providing such great feedback on these questions. I really like the answers/discussion provided this far.
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Joe Coyle Joe Coyle
I was late to getting access to basecamp, so apologies for my tardiness. 

 Who should be the target population for Cronobacter surveillance? 
  • Like others had suggested, I would recommend less than 12 months of age.  I'm kind of thinking a bit about what would be captured in a case report form from an epidemiological perspective. To me, we're really evaluating whether or not powdered infant formula was consumed and whether or not samples of opened or unopened product are available. Beyond that, I feel like we'd be counting cases for the sake of counting cases, without much public health rationale. 
What Cronobacter cases do you think should be reportable, invasive or all?
  • I would stick with invasive here.  Given the environmental nature of the pathogen and the age cohort we'd be targeting for surveillance, CSF/blood, an/or other sterile sites would be my thinking.
  Should Cronobacter be a nationally notifiable condition?
  • Here is maybe where I would buck the trend.  I would say no here.  I think a standard case definition and surveillance framework does have importance independent of making something nationally notifiable.  We have limited evidence, but from what our colleagues in MN have shared, despite having the pathogen reportable in their state for two decades there have not been instances of a patient isolate from an invasive infection in those less than 1 year of age that has matched to unopened infant formula.  I think I remember hearing 2 Cronobacter detections from opened formula and 1 from unopened formula (though none matched a patient isolate).  
  • I think any of us would say that we would alert CDC and FDA of formula that has Cronobacter present, whether it matches a patient isolate or not. I don't know if we need to make it nationally notifiable to do that.
    • Heck, even if there was only evidence of consuming formula and no product was left, wouldn't folks notify FDA if they knew the lot# or brand/product?
  • I do think that we could face some pushback from CSTE membership on making Cronobacter nationally notifiable, so we will want to have our case really tight if we go that route. 
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