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A CLEAR ROLE IN THE TREATMENT OF CHALLENGING cIAI CASES

Long-term care resident

Resident of long-term care facility known to have high rates of ESBL-producing pathogens

RECENT TRAVELER

Recently traveled to an ESBL-endemic area

PENICILLIN ALLERGY PATIENT

Suspected penicillin allergy, which may compromise treatment options

Resident of long-term care facility known to have high rates of ESBL-producing pathogens

Recently traveled to an ESBL-endemic area

Suspected penicillin allergy, which may compromise treatment options

Long-term
Care Resident

  • 79-year-old man
  • Small-bowel obstruction with perforation revealed on CT scan
  • History of C difficile-associated diarrhea
  • Renal insufficiency

In patients with cIAI...

LONG-TERM CARE IS AN IMPORTANT RISK FACTOR FOR ANTIBIOTIC RESISTANCE1

Prevalence data and clinical guidelines highlight the risk for MDR bacteria

is colonized with Gram-negative MDR bacteria, as reported in a recent systematic review and meta-analysis1

E coli was the most commonly isolated resistant pathogen, and the rectum was the most common site of colonization1

SIS and IDSA guidelines consider IAI in nursing home patients to be an infection at risk for involvement of MDR bacteria2,3

Additional risk factors associated with increased MDR Gram-negative bacteria colonization1

  • Advanced age
  • Comorbid chronic diseases
  • Recurrent hospitalization
  • Extensive antimicrobial exposure
  • Frequent interaction with health care workers
  • Reduced functional status
  • Advanced dementia
  • Fecal incontinence
  • Severe sepsis on hospital admission
  • Nonambulatory status
  • Medical device in place

Long-term care residency can pose challenges to current treatment options, including

Increased resistance to piperacillin/tazobactam, cefepime, and meropenem4

Reduced activity of piperacillin/tazobactam in the presence of ESBLs5

Required dosage adjustment for piperacillin/tazobactam, meropenem, and ertapenem in patients with renal impairment6-8

Increased presence of C difficile infection, limiting the utility of fluoroquinolones and many beta-lactam antibiotics9,10

Recent
Traveler

  • 53-year-old woman
  • Diagnosed with perforated diverticulitis (Hinchey stage IV)
  • Received extended-duration oral antibiotics for 2 episodes of diverticulitis in the past 3 years, treated in the outpatient setting

In patients with cIAI...

IDENTIFYING TRAVEL TO HIGH-RESISTANCE REGIONS CAN BE KEY TO AVOIDING DELAYED APPROPRIATE ANTIBIOTIC THERAPY1

Areas of high ESBL-E prevalence put travelers at risk for colonization by resistant pathogens2,3,a

K pneumoniae
E coli

Resistance Rates to Third-Generation Cephalosporins

Data include aggregated resistance rates for isolates (includes intermediate resistance) from blood and cerebrospinal fluid (ie, invasive) from inpatients of all ages. Because of differences in scope of collections and testing methods, caution should be exercised in comparing across countries. Country boundaries/designations do not represent CDDEP opinion concerning the legal status of any country, territory, city, or area of its authorities, or concerning the delimitation of its frontiers or boundaries. Areas in light gray represent countries with data on fewer than 30 isolates, data not related to third-generation cephalosporins, or no data available.3

Source: Center for Disease Dynamics, Economics & Policy. ResistanceMap: antibiotic resistance. 2019.

Consider these risk factors for colonization with ESBL-producing Enterobacteriaceae among travelers4,5

Destination

Traveler’s diarrhea

Preexisting chronic
bowel disease

Antibiotic use
during travel

Coadministration of loperamide and antimicrobial drugs for traveler’s diarrhea greatly increased ESBL-E colonization risk.6

Persistence of Colonization

The rate of colonization persistence with resistant Enterobacteriaceae at 6 months post travel ranged from 6% to 24% in 5 studies of Dutch travelers7; 11.3% remained colonized at 12 months in 1 study5

Delayed appropriate therapy results in negative outcomes8

Failure of initial antibiotic therapy increased the risk of negative clinical and economic consequences in patients with cIAI

Increased duration of IV antibiotic therapy by 5.6 days

Increased cost by $6,368

Increased hospital stay by 4.6 days

Increased mortality risk by nearly 4 times

Penicillin
Allergy Patient

  • 66-year-old woman
  • CT scan revealed perforated appendix
  • 60 days post hospitalization and antibiotic treatment for community-acquired pneumonia

    Prior to initiating treatment, the options include

  • Attempting to obtain an accurate, in-depth history1
  • Delaying treatment to conduct a penicillin allergy skin test1,2

IN PENICILLIN-ALLERGIC PATIENTS WITH cIAI, CONSIDER YOUR OPTIONS

If penicillin allergy is suspected or confirmed, recognize the challenges presented by these current options:

Carbapenems
Carbapenems
  • Cross-reactivity is a risk for patients reporting a penicillin allergy3,4
    • Severe hypersensitivity reactions have been reported in patients treated with another beta-lactam
  • To preserve the effectiveness of carbapenems, institutions should consider carbapenem alternatives
    • For penicillin-allergic patients with suspected ESBLs, these options have been limited in the past5
Cephalosporins
Cephalosporins
  • Generally not active against ESBLs, so they may not provide appropriate coverage for patients with cIAI5,6
  • Cross-reactivity is a risk for patients reporting a penicillin allergy7,8
  • Additional therapy is required for appropriate coverage of anaerobes6
Fluoroquinolones
Fluoroquinolones
  • ESBL-positive pathogens are often resistant to fluoroquinolones9
    • SIS guidelines caution against use of fluoroquinolones for ESBLs6
  • Associations with serious safety concerns have led to boxed warnings10-13
Aztreonam
Aztreonam
  • Limited range of coverage as an empiric monotherapy option6
    • Recommended in combination with vancomycin and metronidazole due to inadequate Gram-positive and anaerobic coverage
  • Because of its low activity against ESBLs, aztreonam is not recommended for use in patients with cIAI at risk for harboring ESBLs14
  • Dosage adjustment required in patients with renal impairment15
  • Cross-reactivity is a risk for patients with a history of hypersensitivity to other beta-lactams15

See how XERAVA can benefit these patients

SEE THE DATA

C difficile, Clostridioides (Clostridium) difficile; cIAI, complicated intra-abdominal infection; CT, computed tomography; E coli, Escherichia coli; ESBL, extended-spectrum beta-lactamase; IAI, intra-abdominal infection; IDSA, Infectious Diseases Society of America; MDR, multidrug-resistant; SIS, Surgical Infection Society.

References: 1. Aliyu S, Smaldone A, Larson E. Prevalence of multidrug-resistant gram-negative bacteria among nursing home residents: a systematic review and meta-analysis. Am J Infect Control. 2017;45(5):512-518. 2. Solomkin JS, Mazuski JE, Bradley JS, et al. Diagnosis and management of complicated intra-abdominal infection in adults and children: guidelines by the Surgical Infection Society and the Infectious Diseases Society of America [published correction appears in Clin Infect Dis. 2010;50(12):1695]. Clin Infect Dis. 2010;50(2):133-164. 3. Mazuski JE, Tessier JM, May AK, et al. The Surgical Infection Society revised guidelines on the management of intra-abdominal infection. Surg Infect (Larchmt). 2017;18(1):1-76. 4. Vazquez-Guillamet MC, Vazquez R, Micek ST, Kollef MH. Predicting resistance to piperacillin-tazobactam, cefepime and meropenem in septic patients with bloodstream infection due to gram-negative bacteria. Clin Infect Dis. 2017;65(10):1607-1614. 5. Zalacain M, Biedenbach DJ, Badal RE, Young K, Motyl M, Sahm DF. Pathogen prevalence and antimicrobial susceptibility among Enterobacteriaceae causing hospital-associated intra-abdominal infections in adults in the United States (2012-2013). Clin Ther. 2016;38(6):1510-1521. 6. Zosyn [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals, Inc.; Rev. 2018. 7. Merrem IV [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; Rev. 2016. 8. Levofloxacin [prescribing information]. Lake Forest, IL: Hospira, Inc.; Rev. 2019. 9. Dingle KE, Didelot X, Quan TP, et al; Modernising Medical Microbiology Informatics Group. Effects of control interventions on Clostridium difficile infection in England: an observational study. Lancet Infect Dis. 2017;17(4):411-421. 10. Tariq R, Cho J, Kapoor S, et al. Low risk of primary Clostridium difficile infection with tetracyclines: a systematic review and metaanalysis. Clin Infect Dis. 2018;66(4):514-522.

CDDEP, Center for Disease Dynamics, Economics & Policy; cIAI, complicated intra-abdominal infection; ESBL, extended-spectrum beta-lactamase; E coli, Escherichia coli; ESBL-E, extended-spectrum beta-lactamase–producing Enterobacteriaceae; IV, intravenous; K pneumoniae, Klebsiella pneumoniae.

References: 1. Reuland EA, Sonder GJ, Stolte I, et al. Travel to Asia and traveller’s diarrhoea with antibiotic treatment are independent risk factors for acquiring ciprofloxacin-resistant and extended spectrum beta-lactamase-producing Enterobacteriaceae—a prospective cohort study. Clin Microbiol Infect. 2016;22(8):731.e1-e7. 2. Frost I, Van Boeckel TP, Pires J, Craig J, Laxminarayan R. Global geographic trends in antimicrobial resistance: the role of international travel [published online May 22, 2019]. J Travel Med. 2019:taz036. doi:10.1093/jtm/taz036. 3. Center for Disease Dynamics, Economics & Policy (CDDEP). Antibiotic resistance map. https://resistancemap.cddep.org/AntibioticResistance.php. Accessed August 22, 2019. 4. Woerther P-L, Andremont A, Kantele A. Travel-acquired ESBL-producing Enterobacteriaceae: impact of colonization at individual and community level. J Travel Med. 2017;24(suppl 1):S29-S34. 5. Arcilla MS, van Hattem JM, Haverkate MR, et al. Import and spread of extended-spectrum beta-lactamase-producing Enterobacteriaceae by international travellers (COMBAT study): a prospective, multicentre cohort study. Lancet Infect Dis. 2017;17(1):78-85. 6. Kantele A, Mero S, Kirveskari J, Lääveri T. Increased risk for ESBL-producing bacteria from co-administration of loperamide and antimicrobial drugs for travelers’ diarrhea. Emerg Infect Dis. 2016;22(1):117-120. 7. Hassing RJ, Alsma J, Arcilla MS, van Genderen PJ, Stricker BH, Verbon A. International travel and acquisition of multidrug-resistant Enterobacteriaceae: a systematic review. Euro Surveill. 2015;20(47). doi:/10.2807/1560-7917.ES.2015.20.47.30074. 8. Edelsberg J, Berger A, Schell S, Mallick R, Kuznik A, Oster G. Economic consequences of failure of initial antibiotic therapy in hospitalized adults with complicated intra-abdominal infections. Surg Infect (Larchmt). 2008;9(3):335-347.

cIAI, complicated intra-abdominal infection; CT, computed tomography; ESBL, extended-spectrum beta-lactamase; SIS, Surgical Infection Society.

References: 1. Sakoulas G, Geriak M, Nizet V. Is a reported penicillin allergy sufficient ground to forgo the multidimensional antimicrobial benefits of beta-lactam antibiotics? Clin Infect Dis. 2019;68(1):157-164. 2. Sacco KA, Bates A, Brigham TJ, Imam JS, Burton MC. Clinical outcomes following inpatient penicillin allergy testing: a systematic review and meta-analysis. Allergy. 2017;72(9):1288-1296. 3. Merrem IV [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals; Rev. 2016. 4. Primaxin [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; Rev. 2018. 5. Antibiotic resistance threats in the United States, 2013. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf. Accessed August 22, 2019. 6. Mazuski JE, Tessier JM, May AK, et al. The Surgical Infection Society revised guidelines on the management of intra-abdominal infection. Surg Infect (Larchmt). 2017;18(1):1-76. 7. Fortaz [prescribing information]. Buena, NJ: Teligent Pharma, Inc.; 2017. 8. Cefazolin [prescribing information]. Lake Forest, IL: Hospira, Inc.; Rev. 2018. 9. Zalacain M, Biedenbach DJ, Badal RE, Young K, Motyl M, Sahm DF. Pathogen prevalence and antimicrobial susceptibility among Enterobacteriaceae causing hospital-associated intra-abdominal infections in adults in the United States (2012-2013). Clin Ther. 2016;38(6):1510-1521. 10. Levofloxacin [prescribing information]. Lake Forest, IL: Hospira, Inc.; Rev. 2019. 11. Cipro [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; Rev. 2016. 12. Singh S, Nautiyal A. Aortic dissection and aortic aneurysms associated with fluoroquinolones: a systematic review and meta-analysis. Am J Med. 2017;130(12):1449-1457. 13. Pasternak B, Inghammar M, Svantröm H. Fluoroquinolone use and risk of aortic aneurysm and dissection: nationwide cohort study. BMJ. 2018;360:k678. 14. Doi Y, Park YS, Rivera JI, et al. Community-associated extended-spectrum beta-lactamase–producing Escherichia coli infection in the United States. Clin Infect Dis. 2013;56(5):641-648. 15. Azactam [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; Rev. 2018.

Indications and Usage; Important Safety Information

EXPAND COLLAPSE

Indications and Usage

XERAVA is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients 18 years or older.

Limitations of Use

XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI).

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Important Safety Information

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥3%) were infusion site reactions (7.7%), nausea (6.5%), and vomiting (3.7%).

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for XERAVA.

Indications and Usage

XERAVA is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients 18 years or older.

Limitations of Use

XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI).

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Important Safety Information

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥3%) were infusion site reactions (7.7%), nausea (6.5%), and vomiting (3.7%).

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for XERAVA.