scholarly journals Clinical complications in patients with primary and recurrent Clostridioides difficile infection: A real-world data analysis

2021 ◽  
Vol 9 ◽  
pp. 205031212098673
Author(s):  
Paul Feuerstadt ◽  
Mena Boules ◽  
Laura Stong ◽  
David N Dahdal ◽  
Naomi C Sacks ◽  
...  
Keyword(s):  
Loop Ileostomy ◽  
Charlson Comorbidity Index Score ◽  
Real World Data ◽  
Infection Group ◽  
Bowel Surgery ◽  
Clinical Complications ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection ◽  
Infection Episode

Objective: Clostridioides difficile infection and recurrent C. difficile infection result in substantial economic burden and healthcare resource use. Sepsis and bowel surgery are known to be serious complications of C. difficile infection. This study evaluated clinical complications in patients with C. difficile infection and recurrent C. difficile infection during a 12-month period following the primary C. difficile infection. Methods: A retrospective analysis of commercial claims data from the IQVIA PharMetrics Plus™ database was conducted for patients aged 18–64 years with an index C. difficile infection episode requiring inpatient stay or an outpatient visit for C. difficile infection followed by a C. difficile infection treatment. Each C. difficile infection episode ended after a 14-day C. difficile infection-claim-free period was observed. Recurrent C. difficile infection was defined as a further C. difficile infection episode within an 8-week window following the claim-free period. Clinical complications were documented over 12 months of follow-up and stratified by the number of recurrent C. difficile infection episodes (0 rCDI, 1 rCDI, 2 rCDI, and 3+ rCDI). Results: In total, 46,571 patients with index C. difficile infection episode were included. During the 6-month pre-index, the mean (standard deviation) baseline Charlson comorbidity index score, by increasing the recurrent C. difficile infection group, was 1.2 (1.9), 1.5 (2.2), 1.8 (2.3), and 2.3 (2.5). During the 12-month follow-up, sepsis occurred in 16.5%, 27.3%, 33.1%, and 43.3% of patients, and subtotal colectomy or diverting loop ileostomy was performed in 4.6%, 7.3%, 8.9%, and 10.5% of patients, respectively, by increasing the recurrent C. difficile infection group. Conclusions: Reduction in recurrent C. difficile infection is an important step to reduce the burden of serious clinical complications, and new treatments are needed to reduce C. difficile infection recurrence.

scholarly journals Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection

2020 ◽  
Vol 10 (1) ◽  
pp. 2
Author(s):  
Rosa Escudero-Sánchez ◽  
María Ruíz-Ruizgómez ◽  
Jorge Fernández-Fradejas ◽  
Sergio García Fernández ◽  
María Olmedo Samperio ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Real World ◽  
Recurrence Rates ◽  
Factors Associated ◽  
Clostridioides Difficile ◽  
Multicentre Cohort Study ◽  
Clostridioides Difficile Infection ◽  
Prevention Of Recurrence ◽  
Multicentre Cohort

Bezlotoxumab is marketed for the prevention of recurrent Clostridioides difficile infection (rCDI). Its high cost could be determining its prescription to a different population than that represented in clinical trials. The objective of the study was to verify the effectiveness and safety of bezlotoxumab in preventing rCDI and to investigate factors related to bezlotoxumab failure in the real world. A retrospective, multicentre cohort study of patients treated with bezlotoxumab in Spain was conducted. We compared the characteristics of cohort patients with those of patients treated with bezlotoxumab in the pivotal MODIFY trials. We assessed recurrence rates 12 weeks after completion of treatment against C. difficile, and we analysed the factors associated with bezlotoxumab failure. Ninety-one patients were included in the study. The cohort presented with more risk factors for rCDI than the patients included in the MODIFY trials. Thirteen (14.2%) developed rCDI at 12 weeks of follow-up, and rCDI rates were numerically higher in patients with two or more previous episodes (25%) than in those who had fewer than two previous episodes of C. difficile infection (CDI) (10.4%); p = 0.09. There were no adverse effects attributable to bezlotoxumab. Despite being used in a more compromised population than that represented in clinical trials, we confirm the effectiveness of bezlotoxumab for the prevention of rCDI.

scholarly journals 797. Management of Patients with Multiple Clostridioides difficile Infection Recurrences using a Tapered-Pulsed Fidaxomicin Strategy

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S441-S442
Author(s):  
Xing Tan ◽  
Andrew M Skinner ◽  
Benjamin Sirbu ◽  
Larry H Danziger ◽  
Dale N Gerding ◽  
...  
Keyword(s):  
First Episode ◽  
Initial Symptom ◽  
Once Daily ◽  
The Past ◽  
Clostridioides Difficile ◽  
Time To Recurrence ◽  
Clostridioides Difficile Infection ◽  
The Mean ◽  
Systemic Antibiotics

Abstract Background There is a paucity of data assessing outcomes of alternate fidaxomicin strategies in patients with recurrent Clostridioides difficile infection (rCDI). The objective of our study is to evaluate a tapered-pulsed (T-P) fidaxomicin regimen that was administered immediately following a course of CDI treatment with initial symptom resolution in patients with multiple rCDI. Methods We reviewed the characteristics and outcomes of 46 consecutive patients who received T-P fidaxomicin between January 1, 2014-June 30, 2019 in a specialty CDI clinic. The first episode in which fidaxomicin T-P was administered was analyzed. Failure was defined as the persistence of diarrhea and/or the need for additional CDI treatment at any time on T-P fidaxomicin. Sustained clinical cure (SCC) was defined as resolution of diarrhea without recurrence. Recurrence was defined as the return of diarrhea requiring retreatment with CDI therapy after completion of T-P fidaxomicin. Both SCC and recurrence were evaluated at 30 and 90 days after completion of T-P fidaxomicin. Results The mean±SD age of the 46 patients was 63.2±19.9 years, 71.7% were female, and the mean±SD CDI episodes within the past year was 3±1.4 . Most patients (73.9%) had previously failed a vancomycin tapered and/or pulsed regimen. Prior to administering T-P fidaxomicin, a treatment regimen was given to ensure resolution of symptoms. The CDI treatment most commonly used (58.7%) was vancomycin. The T-P fidaxomicin regimen used consisted of 200 mg given once daily for 7 days followed by 200 mg every other day for a median (min-max) duration of 33 (6-120) days. Two patients (4%) failed to respond to T-P fidaxomicin; 34 (74%) and 28 (61%) achieved SCC at 30 and 90 days, respectively. Among the 44 patients that successfully completed the T-P fidaxomicin regimen, recurrence developed in 10 (22.7%) and 16 (36.4%) of patients at 30 and 90 days, respectively, with a median (min-max) time to recurrence of 20 (3-87) days (Figure 1). Four patients with recurrence had received subsequent systemic antibiotics. Figure 1. Course of CDI therapy and follow-up Conclusion A tapered-pulsed fidaxomicin strategy may be effective in patients with multiply rCDI who are refractory to other treatments, including a vancomycin tapered and pulsed regimen. Disclosures Larry H. Danziger, PharmD, Merck (Speaker’s Bureau)

scholarly journals 2374. Healthcare Resource Use, Costs, and Recurrences in Patients with Clostridioides difficile Infection: A Real-world Data Analysis

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S819-S819
Author(s):  
Winnie Nelson ◽  
Laura Stong ◽  
Naomi Sacks ◽  
Alexandria Portelli ◽  
Bridget Healey ◽  
...  
Keyword(s):  
Resource Utilization ◽  
Resource Use ◽  
Healthcare Resource ◽  
Healthcare Resource Utilization ◽  
Healthcare Resource Use ◽  
Diagnosis Code ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection ◽  
Ed Visits

Abstract Background Clostridioides difficile infection (CDI), especially recurrent CDI (rCDI), is associated with high morbidity and resource use and imposes a significant burden on the US healthcare system. The objective of this study was to evaluate the burden of rCDI on healthcare resource utilization. Methods A retrospective study analyzed commercial claims data from patients aged 18–64 years old in the IQVIA PharMetrics Plus™ database. CDI episodes required an inpatient stay with CDI diagnosis code (ICD-9-CM 008.45; ICD-10-CM A04.7, A04.71, A04.72), or an outpatient medical claim with CDI diagnosis code plus a CDI treatment, and index episodes occurred from January 1, 2010 to June 30, 2017. Only patients who were observable 6 months before and 12 months after the index CDI episode were included. Each CDI episode was followed by a 14-day claim-free period after the end of treatment. rCDI was defined as another CDI episode within an 8-week window immediately after the claim-free period. Number of CDI and rCDI episodes, healthcare resource use, and costs were calculated over 12-month follow-up and stratified by number of rCDI episodes. Costs were adjusted to 2018 dollars. Results 46,571 patients with an index CDI episode were included, with 3,129 (6.7%) who had 1 rCDI, 472 (1.0%) who had 2 rCDI, and 134 (0.3%) who had 3+ rCDI episodes. Mean age was 47.4 years, and 62.4% were female. In the 12-month follow-up, the mean (SD) numbers of inpatient visits were 1.4 (2.1) for those with no rCDI, 2.7 (3.4) for those with 1 rCDI, 3.7 (3.9) for those with 2 rCDI, and 5.8 (6.0) for those with 3+ rCDI episodes. Emergency department (ED) visits had a similar trend, with mean (SD) number of visits of 1.5 (3.5), 2.5 (6.0), 3.7 (7.0), and 4.6 (13), respectively for the four study groups. All-cause costs after the index CDI were $71,980 for those with no rCDI, $131,953 for those with 1 rCDI, $180,574 for those with 2 rCDI, and $207,733 for those with 3+ rCDI. Conclusion CDI and rCDI are associated with substantial healthcare resource utilization and direct medical costs. During the 12 months after an index CDI episode, the number of inpatient admissions and ED visits increased substantially for patients with an rCDI episode. Direct medical costs for patients with rCDI also increased with number of recurrences. Disclosures All authors: No reported disclosures.

Colocutaneous fistula following Clostridioides difficile infection managed as an ‘autocolostomy’: a novel approach to a recognised complication

2021 ◽  
Vol 14 (4) ◽  
pp. e238720
Author(s):  
Marriam Ahmed ◽  
Kiran Randhawa ◽  
Anthony Kawesha ◽  
Akinfemi Ayobami Akingboye
Keyword(s):  
Colorectal Disease ◽  
Laparoscopic Anterior Resection ◽  
Clostridioides Difficile ◽  
Novel Approach ◽  
Colocutaneous Fistula ◽  
Clostridioides Difficile Infection ◽  
Definitive Repair ◽  
Physiological Impact

Colocutaneous fistula is a rare entity in colorectal disease. We present a case of colocutaneous fistula in a patient whose postoperative course following a laparoscopic anterior resection for sigmoid cancer was complicated by Clostridioides difficile colitis. During the follow-up period, it was found that his bowel contents were preferentially discharging through this fistula which had taken up the role of an ‘autocolostomy’. Given the physiological impact of an additional surgical procedure, a definitive repair of the fistula was deferred and instead the patient was taught to manage it in keeping with general principles of stoma care. Over the subsequent follow-up period, he has now developed a large parastomal hernia and is being considered for definitive repair.

Surotomycin (A Novel Cyclic Lipopeptide) vs. Vancomycin for the Treatment of Clostridioides difficile Infection: A Systematic Review and Meta-analysis

2019 ◽  
Vol 14 (3) ◽  
pp. 166-174 ◽  
Author(s):  
Aziz Muhammad ◽  
Desai Madhav ◽  
Fatima Rawish ◽  
Thoguluva C. Viveksandeep ◽  
Eid Albert ◽  
...  
Keyword(s):  
Clinical Cure ◽  
Meta Analysis ◽  
Promising Alternative ◽  
Cyclic Lipopeptide ◽  
Treatment And Prevention ◽  
Clostridioides Difficile ◽  
Specific Strain ◽  
Clostridioides Difficile Infection ◽  
Cure Rates

Background: Current guidelines recommend the use of vancomycin for the initial treatment of moderate to severe Clostridioides difficile Infection (CDI). Surotomycin, a novel antibiotic, has been utilized for the management of CDI with variable results. Methods: A systematic literature search was performed using the following electronic databases [Medline, Embase, google scholar and Cochrane] for eligible studies. Randomized controlled trials comparing Surotomycin with Vancomycin for the CDI treatment were included. Demographic variables and outcomes (CDI resolution, CDI recurrence, B1/NAP1/027-specific strain treatment, B1/NAP1/027-strain recurrence, death not related to treatment) were analyzed. The primary outcome was clinical cure rate defined as the resolution of CDI at the end of the 10-day drug course. Results: Three RCTs met the inclusion criteria with a total of 1280 patients with CDI who received either surotomycin 250 mg twice daily (642 patients) or vancomycin 125 mg four times daily (638 patients). Clinical cure rates after 10 days of treatment with either surotomycin or vancomycin were not significantly different (pooled OR: 0.89, 95% CI 0.66-1.18, p=0.41). Sustained clinical response at clinical follow-up and the overall recurrence of CDI were also not significantly different between the two groups – pooled OR 1.15 (95% CI 0.89-1.50, p=0.29) and pooled OR 0.74 (95%CI 0.52- 1.04, p=0.08), respectively. With regards to the NAP1/BI/027 strain, patients in the surotomycin group had significantly lower rates of recurrence compared to vancomycin (pooled OR 0.35, 95% CI 0.19-0.63, p<0.01). Conclusion: Surotomycin is non-inferior to vancomycin and offers a promising alternative for the treatment and prevention of C. diff infection.

scholarly journals 766. Readmissions of Hospitalized Patients with Clostridioides difficile Infection (CDI) for Recurrent CDI Is Common

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S480-S480
Author(s):  
Emily N Drwiega ◽  
Larry H Danziger ◽  
Stuart Johnson ◽  
Andrew M Skinner
Keyword(s):  
Medical Center ◽  
Hospital Readmissions ◽  
Panel Member ◽  
Hospitalized Patients ◽  
Recurrent Episode ◽  
Review Panel ◽  
Infectious Disease Physician ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection

Abstract Background Hospital acquired infections (HAI) and hospital readmissions are of particular focus by Centers for Medicare and Medicaid Services. Clostridioides difficile infection (CDI) is an HAI notorious for causing recurrent illness and potentially resulting in re-hospitalizations. The purpose of our study was to identify the frequency of follow-up appointments in patients with CDI and determine the rate of re-hospitalization for recurrent CDI (rCDI). Methods This was a single-center, retrospective, chart review at a tertiary medical center. Through the electronic medical record, we queried all hospitalized patients with a positive stool test for C. difficile (GI panel PCR, FilmArray, Biofire, or C. difficile PCR, Xpert CD assay, Cepheid) with or without an ICD-10 code Enterocolitis due to C. difficile (A04.7, A04.71, A04.72) from January 2018 through April 2018. Demographic and clinical data at the time of diagnosis and up to 90 days after were collected from patient records. Results One-hundred and eighty-five patient episodes were evaluated. Of these, 147 (79.5%) were primary CDI, 13 (7.0%) were rCDI, and 25 (13.5%) were determined to be colonization. Twenty-two (11.9%) patients from the total cohort attended a follow-up appointment for CDI within 30 days, most often with a primary care provider or infectious disease physician. Twenty-three (12.4%) patients, 18 of whom were hospitalized for primary CDI episodes, developed a recurrent episode within 90 days of their initial CDI episode. Of these 23 patients with rCDI, 10 (43.5%) patients were re-hospitalized for their rCDI. Only 4 (17.4%) patients with rCDI had a follow-up appointment after their primary episode and among the 10 patients re-hospitalized for rCDI, only 2 (20.0%) patient had been seen for follow up for their previous CDI episode. Conclusion In our study, few patients had a follow-up appointment for CDI. Also, more than one third of the patients who had rCDI had to be re-hospitalized for the recurrent episode. Our study highlights a concern that the majority of patients re-hospitalized with rCDI did not have a follow-up appointment within 30 days of their initial diagnosis. Further study is necessary to determine if a dedicated follow-up appointment for CDI would result in decreased re-hospitalizations associated with rCDI. Disclosures Stuart Johnson, MD, Acurx Pharmaceuticals (Advisor or Review Panel member)Bio-K+ (Advisor or Review Panel member)Ferring Pharmaceutical (Advisor or Review Panel member)

scholarly journals 2385. Evaluating the Antibiotic Risk for Clostridioides difficile Infection (CDI): Comparing Piperacillin/Tazobactam to Cefepime and Ceftazidime

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S823-S824
Author(s):  
Shardul Rathod ◽  
Dayna McManus ◽  
Jose Rivera-Vinas ◽  
Jeffrey E Topal ◽  
Richard A Martinello
Keyword(s):  
Logistic Regression ◽  
Hospital Admission ◽  
Multivariate Logistic Regression Model ◽  
Charlson Comorbidity Index Score ◽  
Multivariate Logistic Regression ◽  
Clostridioides Difficile ◽  
Days Of Therapy ◽  
Acid Suppression Therapy ◽  
Clostridioides Difficile Infection ◽  
Healthcare Associated

Abstract Background Clostridioides difficile infection (CDI) is a common healthcare-associated infection (HAI). Past studies have revealed that anti-pseudomonal cephalosporins such as cefepime (FEP) and ceftazidime (CTZ) are associated with a higher CDI risk than β-lactam/β-lactamase inhibitors (BLBLI) such as piperacillin/tazobactam (PTZ). However, there is limited data evaluating the comparative healthcare-associated CDI (HA-CDI) risk associated with BLBLI and anti-pseudomonal cephalosporin therapy. Methods An observational cohort study was performed with patients who received PTZ, FEP, or CTZ at Yale New Haven Hospital and Bridgeport Hospital from February 1, 2013 to June 1, 2018. Patients who received ≥ 3 days of PTZ, FEP, or CTZ therapy were included. Patients under the age of 18, those admitted to oncology, transplant, or pediatric units, and those with < 2 or ≥ 120 days of hospital admission were excluded. Multivariate logistic regression models were constructed to control and to adjust for underlying comorbidities. Results A total of 11,909 patient encounters met the study criteria. The median patient-days of therapy for both the PTZ and FEP/CTZ groups was 4 days (Table 1). FEP/CTZ exposure was associated with a higher CDI risk than PTZ exposure (P = 0.03) (Figure 1) even with higher C. difficile testing frequency in the PTZ group (P < 0.001) (Table 1). Using a multivariate logistic regression model controlling for high-risk antibiotic therapy (ciprofloxacin, clindamycin, ertapenem, meropenem, moxifloxacin), acid suppression therapy (famotidine, lansoprazole, pantoprazole), sex, Charlson comorbidity index score, age, and duration of hospital admission, FEP/CTZ exposure was independently associated with a higher CDI risk than PTZ exposure (Table 2) (Table 3). Conclusion FEP/CTZ exposure was associated with a higher CDI risk than PTZ exposure. PTZ may be associated with a higher risk for non-CDI antibiotic-associated diarrhea which may lead to an increased frequency of testing for CDI. The findings from this study may justify additional antibiotic stewardship efforts to limit the use of empiric FEP/CTZ therapy. Disclosures All authors: No reported disclosures.

scholarly journals Incidence of Clostridioides difficile infections among young and middle-aged adults: Veterans Health Administration

2019 ◽  
Vol 40 (9) ◽  
pp. 997-1005 ◽  
Author(s):  
Ellyn M. Russo ◽  
Jennifer Kuntz ◽  
Holly Yu ◽  
Jeremy Smith ◽  
Ronald George Hauser ◽  
...  
Keyword(s):  
Veterans Health Administration ◽  
Health Concern ◽  
Charlson Comorbidity Index Score ◽  
Veterans Health ◽  
Health Administration ◽  
Middle Aged ◽  
Clostridioides Difficile ◽  
Using Data ◽  
Middle Aged Adult

AbstractObjective:Clostridioides difficile infection (CDI) remains a significant public health concern, resulting in excess morbidity, mortality, and costs. Additional insight into the burden of CDI in adults aged <65 years is needed.Design/Setting:A 6-year retrospective cohort study was conducted using data extracted from United States Veterans Health Administration electronic medical records.Patients/Methods:Patients aged 18–64 years on January 1, 2011, were followed until incident CDI, death, loss-to-follow-up, or December 31, 2016. CDI was identified by a diagnosis code accompanied by metronidazole, vancomycin, or fidaxomicin therapy, or positive laboratory test. The clinical setting of CDI onset was defined according to 2017 SHEA-IDSA guidelines.Results:Of 1,073,900 patients, 10,534 had a CDI during follow-up. The overall incidence rate was 177 CDIs per 100,000 person years, rising steadily from 164 per 100,000 person years in 2011 to 189 per 100,000 person years in 2016. Those with a CDI were slightly older (55 vs 51 years) and sicker, with a higher baseline Charlson comorbidity index score (1.4 vs 0.5) than those without an infection. Nearly half (48%) of all incident CDIs were community associated, and this proportion rose from 41% in 2011 to 56% in 2016.Conclusions:The findings from this large retrospective study indicate that CDI incidence, driven primarily by increasing community-associated infection, is rising among young and middle-aged adult Veterans with high service-related disability. The increasing burden of community associated CDI in this vulnerable population warrants attention. Future studies quantifying the economic and societal burden of CDI will inform decisions surrounding prevention strategies.

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