scholarly journals 697. Outcomes of Tigecycline Use for Clostridioides difficile Infection: A Case Series of 28 Patients

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S449-S449
Author(s):  
Emma C Phillips ◽  
Cirle A Warren ◽  
Gregory Madden

Abstract Background Clostridioides difficile infection remains a highly morbid or lethal condition in an unacceptably large proportion of patients. To date, there are limited and conflicting data to support the use of tigecycline for C. difficile infection and the optimal stratification approach, timing (i.e., initial vs. salvage therapy), and duration are unclear. Methods We describe in detail a retrospective cohort of 28 C. difficile inpatients treated with tigecycline at UVA Medical Center. We stratify each patient by the Infectious Diseases Society of America’s guidelines on severity of infection and detail the timing and duration of tigecycline therapy in each case. We further characterize the effect of tigecycline on 90-day mortality and recurrence. Results 9/28 (32.1%) patients were treated with tigecycline for fulminant (presence of hypotension, shock, ileus, or megacolon), and 12/28 (42.9%) for severe (white blood cell count over 15x109/L or creatinine over 1.5mg/dL) C. difficile infection. Tigecycline was used in all cases in combination with oral vancomycin +/- metronidazole. The average duration of therapy was 7.6 days, with tigecycline as initial therapy (use within the first 72 hours of the start of directed antimicrobial therapy) in 7/28 (25%) cases. 90-day mortality occurred in 10/26 (35.7%) patients (two did not reach 90-day follow-up), all 10 of which were in-hospital mortalities and 5/10 (50%) occurred in patients with fulminant infection. 7 of the 16 (43.8%) surviving patients that reached 90-day follow-up had recurrent C. difficile infection. Conclusion Patients selected for treatment with tigecycline for C. difficile infection suffered a high rate of in-hospital mortality, especially among the significant proportion with fulminant disease. The rate of recurrent infection was substantial, contrary to some reports of reduced recurrence with tigecycline from the literature. The outcomes of tigecycline (as adjunct or monotherapy) for treatment of severe/fulminant and refractory infection versus standard treatments warrant further retrospective analysis and the benefit of tigecycline in these settings remains to be proven in well-controlled clinical trials. Disclosures All Authors: No reported disclosures

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S66-S67
Author(s):  
Caitlin C Bettger ◽  
Stephanie Giancola ◽  
Robert Cybulski ◽  
Jason Okulicz ◽  
Alice Barsoumian

Abstract Background A 2-step testing strategy for diagnosis of Clostridioides difficile infection (CDI) is recommended to limit over-diagnosis when clinical criteria requirements for stool sample submission cannot be enforced. Real-world evaluations of this strategy are limited. Methods The Antimicrobial Stewardship Program at Brooke Army Medical Center, San Antonio, TX, implemented a 2-step CDI algorithm: polymerase chain reaction (PCR) testing followed by toxin enzyme immunoassay (EIA). The goal was to improve diagnosis of CDI and reduce unnecessary antibiotic use. Patients with PCR+ tests from August 2018 to September 2019 were included. Charts were reviewed for demographics, laboratory data, treatment, and outcomes. Cases were grouped based on concordant (PCR+/EIA+) or discordant (PCR+/EIA-) results. To determine factors contributing to treatment decisions, an analysis of discordant cases were compared by treatment status. Groups were compared by Chi-squared, Fisher’s exact, or Mann-Whitney U tests. Results A total of 216 PCR+ tests from 215 patients were recorded. Of these, 155 (71.8%) were discordant. Demographics, laboratory data, and risk factors for CDI were similar between groups (Table 1; p >0.05 for all). Compared to discordant cases, concordant cases were more frequently hospitalized (59% vs 43.9%; p=0.05), had a higher median daily stool count (5 [4–7] vs 4 [2–6], p=0.03), met criteria for severe CDI (33.3% vs 18.7%; p=0.05), received treatment (95.1% vs 66.5%; p< 0.01) and were readmitted in 30 days with CDI (8.3% vs 1.3%; p=0.02). Among discordant cases, median daily stool count was higher in treated vs untreated cases (4 [3–7] vs 3 [1–5], p=0.02). Otherwise, there was no difference in variables according to treatment status (Table 2; p >0.05 for all). Discordant cases with infectious disease (ID) or gastroenterology (GI) consultation had a high rate of treatment (73.9% and 61.1%, respectively). Table 1. Characteristics and outcomes of patients with concordant and discordant tests. Table 2. Characteristics and outcomes of treated and untreated patients with discordant tests. Conclusion Implementation of 2-step strategy reduced antibiotic treatment by nearly 30%. However, the majority of discordant cases were deemed clinically significant and received treatment by providers, including ID or GI specialists. Further studies are needed to determine the unmeasured factors that guide treatment decisions in discordant cases. Disclosures All Authors: No reported disclosures


2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S480-S480
Author(s):  
Emily N Drwiega ◽  
Larry H Danziger ◽  
Stuart Johnson ◽  
Andrew M Skinner

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)


Author(s):  
Tadas Urbonas ◽  
Gianluca Ianiro ◽  
Rolandas Gedgaudas ◽  
Povilas Sabanas ◽  
Mindaugas Urba ◽  
...  

Background and Aims: Many studies have shown a high effectiveness of fecal microbiota transplantation (FMT) in treatment of recurrent or refractory Clostridioides difficile infection (CDI). Nevertheless, data on long term outcomes and complications after FMT are still lacking. We aimed to evaluate the efficacy, the peri- procedural safety profile and the long-term efficacy and safety of FMT for recurrent CDI during a median follow up period of 24 months. Methods: Our study included 60 consecutive patients that were treated from 2015 to 2019 for recurrent CDI. In all patients FMT was performed through the nasoenteric tube placed during gastroscopy. Fresh donor feces were used for FMT from unrelated donors. Pre-FMT preparation included CDI treatment with oral vancomycin 500 mg q.i.d. for at least five days and proton pump inhibitor (PPI) administration before FMT. Follow up data included information about recurrent CDI episodes, early and late complications, health status at 3, 12 and 24 months after FMT. Results: FMT was performed for 60 patients (median age 72.5 years) with recurrent CDI. Clinical improvement after the first FMT procedure was observed in 48 patients (80%). Ten of 12 initially non-responding patients had a clinical resolution after a second FMT leading to an increased overall cure rate of 96.7 %. The remaining two patients needed a third FMT with a final overall cure rate of 100%. Nine of 60 patients were under immunosuppressive therapy. Six immunosuppressed patients were in the group of initial responders and the remaining three in the initially non-responder group. We observed a very low rate of adverse events in the short and long-term after FMT. During the first eight weeks after the FMT procedure, the death of three patients occurred, but they were not related to the FMT procedure. Patients were followed up for a median of 20 months, with the range from 12 to 55 months. During the follow-up period no long-term serious adverse events (SAE) were documented. Conclusions: Our study confirms excellent efficacy rates of FMT in the treatment of recurrent CDI. In addition, this study shows that it is possible to avoid short term SAE when FMT is administered via a nasoenteric tube by following a very stringent peri-procedural patient follow-up protocol. Our study also demonstrates good safety with a low rate of long-term adverse events after FMT.


2020 ◽  
Vol 10 (1) ◽  
pp. 2
Author(s):  
Rosa Escudero-Sánchez ◽  
María Ruíz-Ruizgómez ◽  
Jorge Fernández-Fradejas ◽  
Sergio García Fernández ◽  
María Olmedo Samperio ◽  
...  

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.


2021 ◽  
Vol 9 ◽  
pp. 205031212098673
Author(s):  
Paul Feuerstadt ◽  
Mena Boules ◽  
Laura Stong ◽  
David N Dahdal ◽  
Naomi C Sacks ◽  
...  

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.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S438-S439
Author(s):  
Tanner M Johnson ◽  
Amanda Howard ◽  
Kerry Schwarz ◽  
Lorna Allen ◽  
Misha Huang ◽  
...  

Abstract Background Recurrent Clostridioides difficile infection (rCDI) within 180 days of the index episode is associated with a 33% increase in mortality and, to-date, few treatment options exist to prevent recurrent infection. Bezlotoxumab (BEZ) is a novel therapeutic option for the prevention of rCDI, yet limited data exist regarding its effectiveness in patients at high-risk for recurrence outside of controlled trials. This study aimed to compare BEZ to a historical standard of care (SoC) cohort for the prevention of rCDI in patients at high risk for recurrence. Methods A multi-center retrospective cohort study of patients within an academic health-system with one or more risk factors for rCDI. Patients received SoC with oral vancomycin (VAN) or fidaxomicin (FDX) from January 2015 to December 2017 or BEZ, in addition to oral SoC, from September 2017 to September 2019. The primary outcome was rCDI within 90 days of completion of oral VAN or FDX. Secondary outcomes included all-cause readmission, all-cause mortality, and safety events at 90 days. Results One-hundred twenty patients received BEZ in addition to SoC (n=47) or SoC alone (n=73). Mean (SD) age was 55 (16) years, mean (SD) number of lifetime CDI was 3 (2) episodes, and 30.8% of patients had severe CDI. Six (12.8%) patients in the BEZ cohort and thirty-one (42.5%) in the SoC cohort experienced rCDI at 90 days [OR (95% CI) = 0.20 (0.07-0.53), p=< 0.01]. Incidence of all-cause mortality (2.1% vs 5.5%, p=0.67) and all-cause readmission (42.6% vs 56.2%, p=0.20) within 90 days were not statistically different between groups. Patient body weight, timing of BEZ administration, CDI severity, nor prior receipt of fecal microbiota transplantation significantly affected BEZ effectiveness. BEZ was well tolerated with one infusion-related reaction. There were no heart failure exacerbations among BEZ recipients and two exacerbations identified from control group. Conclusion In patients with at least one risk factor for rCDI, BEZ in addition to SoC was associated with lower rates of recurrent infection than SoC alone and may be a reasonable adjunct therapy in high risk patient populations. Disclosures matthew miller, PharmD, Allergan (Speaker’s Bureau)Tetraphase (Speaker’s Bureau)


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S441-S442
Author(s):  
Xing Tan ◽  
Andrew M Skinner ◽  
Benjamin Sirbu ◽  
Larry H Danziger ◽  
Dale N Gerding ◽  
...  

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)


2021 ◽  
Vol 10 (13) ◽  
pp. 2957
Author(s):  
Shira Buchrits ◽  
Anat Gafter-Gvili ◽  
Jihad Bishara ◽  
Alaa Atamna ◽  
Gida Ayada ◽  
...  

Background: Clostridium difficile infection (CDI) causes morbidity and mortality. Platelets have been increasingly recognized as an important component of innate and adaptive immunity. We aimed to assess the incidence of thrombocytopenia and thrombocytosis in CDI and the effect of an abnormal platelet count on clinical outcomes. Methods: This single-center, retrospective cohort study consisted of all adult patients hospitalized in Rabin Medical Center between 1 January 2013 and 31 December 2018 with laboratory confirmed CDI. The primary outcome was 30-day all-cause mortality. Risk factors for 30-day all-cause mortality were identified by univariable and multivariable analyses, using logistic regression. Results: A total of 527 patients with CDI were included. Among them 179 (34%) had an abnormal platelet count: 118 (22%) had thrombocytopenia and 61 (11.5%) had thrombocytosis. Patients with thrombocytosis were similar to control patients other than having a significantly higher white blood cell count at admission. Patients with thrombocytopenia were younger than control patients and were more likely to suffer from malignancies, immunosuppression, and hematological conditions. In a multivariable analysis, both thrombocytosis (OR 1.89, 95% CI 1.01–3.52) and thrombocytopenia (OR 1.70, 95% CI 1.01–2.89) were associated with 30-days mortality, as well as age, hypoalbuminemia, acute kidney injury, and dependency on activities of daily living. A sensitivity analysis restricted for patients without hematological malignancy or receiving chemotherapy revealed increased mortality with thrombocytosis but not with thrombocytopenia. Conclusions: In this retrospective study of hospitalized patients with CDI, we observed an association between thrombocytosis on admission and all-cause mortality, which might represent a marker for disease severity. Patients with CDI and thrombocytopenia also exhibited increased mortality, which might reflect their background conditions and not the severity of the CDI. Future studies should assess thrombocytosis as a severity marker with or without the inclusion of the WBC count.


Hand Surgery ◽  
2013 ◽  
Vol 18 (02) ◽  
pp. 175-178 ◽  
Author(s):  
A. S. C. Bidwai ◽  
F. Cashin ◽  
A. Richards ◽  
D. J. Brown

We present the clinical outcome of patients who underwent RE-MOTION Total Wrist Replacement (TWR) for the treatment of Rheumatoid arthritis involving the wrist. Ten patients were available for follow-up, ranging from one to five years after index surgery. Two patients required surgical intervention for wound breakdown, including one patient who required a radial forearm flap for skin coverage. No patients required revision surgery or conversion to fusion. Patients who did not have complications gained statistically significant pain relief and improvement in mean overall flexion. In this small case series with short to medium results patients reported an improvement in terms of flexion and pain. Despite this, the question of efficacy of TWR compared to fusion in the long term remains unanswered due to the high rate of complications.


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