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Suspected Intra-abdominal sepsis

The patient presents with suspected sepsis.

Discussion

Upon admission, the patient was initially given a broad-spectrum antibiotics linezolid, aztreonam, and metronidazole for the treatment of suspected intra-abdominal sepsis. Due to the patient’s recent healthcare exposure, she was at risk for organisms such as MRSA (methicillin-resistant Staphylococcus aureus) and Pseudomonas aeruginosa in addition to the more common causes of intra-abdominal infection such as enterobacteriaceae and anaerobic organisms. 

At the time of admission, she had blood cultures obtained, and T2Bacteria ordered. At Lee Health patient selection for T2Bacteria testing was based on the NEWS (National Early Warning Score) scoring system. The NEWS score was developed to standardize the approach to detection of clinical deterioration in acutely ill patients in the United Kingdom, and a score of 7 or higher puts the patient in the high-risk category. This patient also was positive for 3 of 4 SIRS criteria and had a qSOFA score of 2, indicating a high risk of mortality.

Due to the negative blood culture (T2Bacteria results were not reported as this case was part of an observational study), the patient remained on empiric therapy for 5 days and then was changed to oral therapy and discharged 2 days later. Had the T2Bacteria result been reported, the patient could have been changed to meropenem to cover the E. coli and P. aeruginosa, allowing discontinuation of aztreonam. Given the S. aureus was negative, linezolid could have been discontinued as well. Discontinuation of these two antibiotics within the first 24 hours of admission would have led to ~$6,000 savings in antibiotic charges, and potentially led to earlier discharge on effective oral therapy.

Presentation

53-year-old immunocompromised, morbidly obese female with a recent history of surgery to drain an intra-abdominal abscess. The patient presented at the emergency department 8 days post-op with fever, chills, and abdominal pain. Sepsis was suspected, and the patient was admitted with orders for blood cultures, T2Bacteria®, and broad-spectrum antibiotics.

Patient Selection Criteria

SIRS criteria:

  • Temperature: 103.4
  • Heart Rate: 133 BP90/62
  • Respiratory Rate: 34
  • WBC: 6,800/mm3
  • NEWS Score: 9
  • QSOFA Score: 2

Evaluation and Treatment Decision

Diagnosis 

Suspected Intra-abdominal sepsis

Empiric Therapy

Linezolid, Aztreonam, Metronidazole

Linezolid was chosen for gram-positive coverage due to challenges with vancomycin dosing in obese patients. Aztreonam was chosen for gram-negative coverage due to the patient history of penicillin allergy. Metronidazole was chosen for anaerobic coverage.

T2Bacteria Result

Positive for E. coli and P. aeruginosa and negative for S. aureus, E. faecium, and K. pneumoniae. (SA -, PA + & EC +); T2Bacteria results were not reported as this case was part of an observational study.  

Blood Culture Result

Negative

Decision making based on T2Bacteria Result

The negative S. aureus result meant that the patient did not have MRSA and therefore, linezolid could have been discontinued after the first dose when the T2Bacteria result was available, a 4.5-day reduction in linezolid. The patient’s therapy could have been more targeted gram-negative coverage by switching to meropenem to cover E. coli and P. aeruginosa

Imagine species identification for some of the most common and deadly sepsis-causing pathogens— without having to wait 1 to 5 days or more for blood culture results. 

Patient Health

Early targeted therapy improves patient outcomes; every hour delay of effective antibiotic therapy increases mortality by almost 8% in patients with septic shock. A positive ESKAPE or Candida test result may enable rapid targeted treatment and prevent a serious bloodstream infection from progressing to sepsis. Faster identification of sepsis-causing pathogens means patients are on targeted therapy faster— saving costs for unnecessary antibiotics— and enabling clinicians to treat the source of infection faster. In clinical studies, the T2Bacteria Panel (RUO) identified opportunities to escalate and de-escalate with confidence in patients who were ineffectively treated. (T2-704-4/18 for reference 1) Read more on how Lee Health made a positive impact on patient health.

Laboratory

Sepsis is defined as a life-threatening medical emergency by the CDC. New direct-from-whole blood T2Direct Diagnostics™ are the only FDA-cleared tests proven to complement traditional blood culture methods by identifying the most common and deadly organisms in 3 to 5 hours. Studies demonstrate both the T2Bacteria® Panel and T2Candida® Panel are able to detect some of the most common and clinically relevant pathogens at a limit of detection (LoD) as low as 1 CFU/mL and with a high degree of sensitivity and specificity. The easy to use T2Dx® Instrument is powered by T2MR technology and is not only easy to use but also fits within the most space-constrained environment. The fully automated, walkaway instrument is a clinical multiplex benchtop diagnostic system capable of running tests directly from 3-4 mL of whole blood.

Improved Stewardship Goals

Antibiotic resistance is a growing concern worldwide and a major public health threat. Overuse and inappropriate antibiotic use in patients are a root cause, as patients are being treated for infections empirically without knowing if they are actually infected, often exposing them to incorrect or unnecessary antibiotic therapy. This greatly decreases their chances of survival and increases the problem of antimicrobial resistance. Stewardship Committees are chartered with optimizing the utilization of antimicrobials for the best patient care while minimizing unintended consequences associated with antimicrobial exposure. The inclusion of faster ID of sepsis-causing pathogens as part of a hospital’s stewardship initiatives can enable faster time to improved patient outcomes and de-escalation of antimicrobial drug use. Patient outcomes include reduced hospital and ICU length of stay and de-escalation of unnecessary therapies. More effective use and better cost management of antimicrobial drugs, with the ability to make rapid adjustments, can reduce resistance while improving antimicrobial stewardship and potentially reduce morbidity and mortality outcomes resulting in reducing the cost of sepsis management. Read more about how labs are improving stewardship at Riverside Hospital.

1. Kumar, A, et al. Critical Care Medicine, 2006.

In 2004, microbiologist Carl Nathan, M.D., wrote in a Nature commentary that:

Treating infections with pathogen-specific rather than broad-spectrum antibiotics (whenever possible) will require prior, rapid, accurate and specific diagnosis. It makes no sense to use 21st-century technology to develop drugs targeted at specific infections whose diagnosis is delayed by 19th-century methods.1

In the decade and a half since Dr. Nathan wrote these words, the standard of care has remained mired in “19th-century methods.” Despite important diagnostic improvements made to post-blood culture methods, the days-long culturing of blood remains the foundation for pathogen-specific identification. Since clinicians cannot wait days to act when confronted with a patient suspected of sepsis, the standard of care remains empiric therapy. In the 2018 book, Superbugs: An Arms Race Against Bacteria, Lord Jim O’Neill and his coauthors describe the limitations of empiric therapy:

Doctors usually treat patients using empirical diagnosis, which is little more than an educated guess based on a clinical assessment of the patient’s symptoms, history, and profile. This system is often not good enough to distinguish between bacterial and viral infections, or even to tell if the patient has an infection at all. If a bacterial infection is diagnosed, there is no way to determine if the bacteria are resistant or susceptible to standard treatments using empirical diagnosis since they produce identical symptoms, and our current diagnostic tests to distinguish between them take two days.”2

Empiric therapy works for many patients, it has been demonstrated that approximately 60% of patients are on initial effective therapy, but there remain significant opportunities for improvement.3 A recent 1,400 patient, 11-site clinical trial led by investigators at UPMC found similar gaps: 2 in 3 patients were not on effective therapy at hour zero, and 1 in 5 patients were still on ineffective therapy 24 hours later.4

An Easy “ESKAPE”

Frighteningly, many patients who are not initially on effective therapy are battling a prevalent and deadly “ESKAPE” pathogens that cause the most worry for clinicians. The opportunistic ESKAPE pathogens were dubbed the acronym due to the bacterial pathogens being known for their ability to “escape” response to broad-spectrum antibiotics. The ESKAPE pathogens have been primary beneficiaries of “19th-century methods” of diagnosis. Of the six ESKAPE pathogens, four of the most common, E. faecium, S. aureus, K. pneumoniae, and P. aeruginosa, make up approximately 90% of all ESKAPE bloodstream infections.5  The Infectious Diseases Society of America (IDSA) elevated the profile of these pathogens with a report called “Bad Bugs, No Drugs” providing the ESKAPE name and highlighting the potential health crisis.6  Most of these pathogens are multidrug resistant and increasingly resistant to common empiric therapy such as the combination Vancomycin/Piperacillin-Tazobactam.

The 21st-Century Diagnostic for Fighting ESKAPE Pathogens

Enter the T2Bacteria Panel. The first and only FDA-cleared technology to detect prevalent and deadly ESKAPE pathogens in 3 to 5 hours – directly in whole blood! This breakthrough test is shown to provide results 2.5 days faster than the current standard of care.

Direct from whole blood technology is ushering in a new era of diagnostics, one befitting of 21st-century technology advantages described by Dr. Nathan in 2004.

Don’t wait another decade – it’s time to use 21st-century technology! Find out what it can do for you here.

……………………………………….

1. Nathan, C. (2004). Antibiotics at the crossroads. Nature431(7011), 899.
2. Hall, W, et al. (2018) Superbugs: An Arms Race Against Bacteria. Cambridge, MA.; Harvard University Press
3. Buehler, SS, et al. Clinical microbiology reviews, (2016). 29(1), 59-103.
4. T2Bacteria Pivotal Clinical Study 2018. Manuscript under review.
5. Karlowsky, J. et al. Annals of Clinical Microbiology and Antimicrobials, (2004). 3:7.
6. Infectious Diseases Society of America. (2008, December 9). No ESKAPE! New Drugs Against MRSA, Other Superbugs Still Lacking. ScienceDaily.

The following is edited from a conversation with Sandy Estrada, Pharm.D., BCPS, Vice President, Medical Affairs, T2 Biosystems. Dr. Estrada was previously an Infectious Diseases Clinical Pharmacist for Lee Health in Ft. Myers, FL for 13 years where she served as the Co-Director of Antimicrobial Stewardship, Director of the ID Pharmacy Residency Program, and as a member of the sepsis committee.

Sepsis Committees Get It Right With Direct Patient Care Staff Involvement

Sepsis committees often make a priority of identifying or hiring a sepsis coordinator. This position is typically held by a nurse or emergency department clinician. This leadership role for frontline caregivers helps center the committee’s actions on a passion for patient care and a desire to seek breakthroughs that can reduce sepsis mortality and improve patient outcomes.

Integration with Existing Hospital Committees is Key

Every sepsis committee should be conscious of other ongoing committees and how to maximize its influence and expertise to drive improved patient care.  Many sepsis committees are relatively recent creations. At our hospital, the stewardship committee had been in existence for about a decade when the sepsis committee was first organized. The stewardship committee’s mission of fast and appropriate targeted antibiotic utilization is highly aligned with a core sepsis committee priority. In addition, many individuals were members of both the sepsis and the stewardship committees. Our sepsis committee was very successful when it leveraged and accelerated the work of existing committees, like stewardship.

You Must Get the Right Players at the Table

An effective sepsis committee must be collaborative and have a balanced representation by clinical and administrative leaders. A purely clinical group is at risk of not having support from administration for proposed changes, while a purely administrative group may not have buy-in from the clinicians necessary to implement any changes. In addition, it is important to have someone from the IT department represented; they are key in making sure protocols and order sets get electronically implemented in a timely fashion.

Learn more about our candida test panel:

A recent Pharmacy Practice News article ran with the jarring headline: “Killing the Kidneys to Save the Patient.”1 It drives at an issue facing many hospitals today: widespread use of antibiotics are at times negatively impacting kidney function – because hospitals have such limited data, they struggle to make timely appropriate antibiotic therapy choices.

For millions of patients at risk of sepsis each year, the standard of care is to turn immediately to broad empiric antimicrobial therapy when a patient is suspected of a sepsis-related infection: dose patients with vancomycin and piperacillin-tazobactam, or a similarly broad-spectrum coverage. This is a pre-emptive strike while they wait for a diagnostic result that can identify the causative pathogen of the bloodstream infection – or if there is an infection at all. In fact, over 50% of the time, there is no infection at all! “Vanc” and “pip/tazo,” for example, are relatively cheap and effective – and necessary for a patient’s survival if they have a gram-positive infection like MRSA or a gram-negative bacteria like Pseudomonas aeruginosa or E. coli. When the mortality rate for sepsis rises ~8% each hour the patient goes untreated, the results of undertreatment are devastating.2 So this practice is the right thing to do, but it has consequences.

Kidneys are often paying the price. Broad-spectrum empiric therapy can cause nephrotoxicity or acute kidney injury in patients. Acute kidney injury causes excess waste products in blood and makes it challenging for kidneys to maintain the right balance of fluid in the body, and may negatively affect other organs. Some patients may be required to go on dialysis to help replace kidney function. A recent study demonstrated that vancomycin plus piperacillin-tazobactam increases the odds of acute kidney injury by threefold, and acute kidney injury increases hospital length of stay by approximately 3.5 days and costs by $7,500.3

Enter the heroes!
Every day, antimicrobial stewardship teams face pressure to safely de-escalate or discontinue broad-spectrum antibiotics when they are not needed. How can you convince clinicians that it is safe to change therapy without any diagnostics to guide the decision… because conventional blood culture results take days?

In part to reduce harm to the kidneys, hospitals and stewardship teams are turning to new, faster diagnostics like the FDA-cleared T2Bacteria® Panel. This test provides direct-from-whole-blood infection identification in 3 to 5 hours, without the wait of blood culture.

As described in a new white paper from Lee Health, T2Bacteria is a useful tool to support five antimicrobial stewardship goals including optimizing empiric therapy within hours.4 T2Bacteria research results demonstrate the panel can help rule out of P. aeruginosa and/or S. aureus within hours.

Don’t miss the two detailed case studies where therapy could have been narrowed and optimized days sooner, saving money and reducing the risk of adverse side effects – including the potential to reduce acute kidney injury.

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1. Rosenthal, M. Pharmacy Practice News. July 2018.
2. Kumar, A, et al. Critical Care Medicine,(2006). 34(6), 1589-1596.
3. Luther, M, et al. Open Forum Infectious Diseases, Volume 3, Issue suppl_1, 1 December 2016, 1805, https://doi.org/10.1093/ofid/ofw172.1353
4. Weisz, EE, et al. Stewardship and the T2Bacteria® Panel: Early Research Experience at a Community Hospital. White Paper. September 2018.

Welcome to the first ever T2Blog, an initiative that we take excitedly and seriously. We are excited to create a space where readers can keep up with T2. We are privileged to play a part in fighting sepsis with game-changing diagnostic technology that detects bloodstream infections and may prevent the progression to sepsis. Sepsis is a serious condition and we are serious about having a stake in the sepsis community. Throughout these blogs, we will address inspiring patient stories, challenges in sepsis management, T2’s technology, initiatives, and advancements in the field. So here goes! 

Day-to-day, it’s easy to get bogged down in the essential, but sometimes seemingly disconnected details of diagnostic tests: from reagent primers and probes to sensitivity calculations to get the exact right amount of cells in spiked blood sample. World Sepsis Day is an important reminder to step back and connect with the larger cause that fuels all these activities at T2: to save lives of patients with sepsis and help them return home to their families instead of the tragic, and often avoidable, alternative. This year, our team was fortunate to meet and support many strong sepsis survivors who have dedicated their lives to raising awareness by telling their personal stories in order to help others avoid the same tragic consequences. Their passion, commitment, and firsthand experience have helped fuel T2 during one of the most exciting and pivotal years in our company’s history.

Meet some of the Sepsis survivors that inspire us

Audrey Leishman

In January, we met with Audrey Leishman via video and her husband, PGA Tour Professional Marc Leishman, to learn about Audrey’s battle with sepsis and her outstanding work with the Begin Again Foundation to support sepsis survivors get back on their feed.

Mary Millard

Over the summer, Mary Millard visited our team in Lexington, Massachusetts to share her story. Mary is an inspiration with her willingness to share her personal story with such passion to improve care for similar patients. What could have been a routine cardiac procedure became a lifelong health battle after a bacterial infection was misdiagnosed and incorrectly treated for too long. Her story brings much-needed attention to the devastating health effects of sepsis and hospital-acquired infections. Mary gave permission to share her experience with sepsis – and the impact she could have had with earlier identification and treatment of the increasingly resistant Pseudomonas aeruginosa that forever changed her life.

Emily Edwards

We were inspired by the passion of the family of Emily Edwards, whose life was tragically cut short by sepsis. Her family is part of the National Family Council on Sepsis and hosted a Stepping Out Sepsis 5K in May in Dracut, Massachusetts. We were proud that team orange was there to support their important work!

Join us in our fight against Sepsis

This month, our team at T2 is again “Spiking Out Sepsis” on the front lawn at Hartwell Avenue with a volleyball tournament where the proceeds go to the Sepsis Alliance, an organization doing such valuable work to raise awareness.

Thanks to all the individuals and organizations who are part of the fight against sepsis. Together, we can help eradicate preventable sepsis deaths!

According to the CDC, of the 154 million prescriptions for antibiotics written in doctors’ offices and emergency departments each year, 30% are unnecessary.12

PUBLICATIONS

Over 200 studies published in peer-reviewed journals have featured T2MR in a breadth of applications.