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 Cadazolid vs Vancomycin for the Treatment of Clostridioides difficile Infection: Systematic Review with Meta-analysis

2020 ◽  
Vol 15 (1) ◽  
pp. 4-10
Author(s):  
Aziz Muhammad ◽  
Weissman Simcha ◽  
Fatima Rawish ◽  
Rajani Sabih ◽  
Eid Albert ◽  
...  
Keyword(s):  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Meta Analysis ◽  
Cure Rate ◽  
Promising Alternative ◽  
Clostridioides Difficile ◽  
Experimental Drug ◽  
Clostridioides Difficile Infection ◽  
Diverse Patient Population

Background:: Current guidelines recommend the use of vancomycin for the initial treatment of Clostridioides difficile Infection (CDI). Cadazolid, an experimental drug, has been utilized and compared in several studies with varying results. Methods:: A systematic literature search was performed using electronic databases [Medline, Google Scholar and Cochrane] for eligible studies. Randomized Controlled Trials (RCTs) comparing cadazolid with vancomycin for CDI treatment were included. Demographic variables and outcomes (CDI resolution, CDI recurrence, and adverse events) were collected. The primary outcome was clinical cure rate defined as the resolution of CDI at the end of a 10-day course. Results:: Two studies with three RCTs met the inclusion criteria with a total of 1283 patients with CDI who received either cadazolid 250 mg twice daily (624 patients) or vancomycin 125 mg four times daily (659 patients). Clinical cure rate at the end of the treatment was not statistically significant (pooled OR= 0.82; 95% CI = 0.61 to 1.11; p=0.20; I2= 0%). Sustained clinical response at clinical follow-up was also not significantly different (pooled OR = 1.14; 95% CI = 0.91 to 1.43; p=0.27; I2 = 0 %). Cadazolid had a lower recurrence rate than vancomycin (pooled OR = 0.71; 95% CI = 0.52 to 0.98; p=0.04; I2 = 13 %). Conclusion:: Cadazolid is non-inferior to vancomycin and offers a promising alternative for the treatment of CDI. More studies including RCTs and longitudinal studies with large and diverse patient population are needed to further confirm this. Furthermore, cadazolid should also be compared with fidaxomicin in a head-to-head trial to evaluate their efficacy for CDI.

scholarly journals A prospective, observational study of fidaxomicin use for Clostridioides difficile infection in France

2021 ◽  
Vol 49 (6) ◽  
pp. 030006052110212
Author(s):  
Benoit Guery ◽  
Pierre Berger ◽  
Remy Gauzit ◽  
Magali Gourdon ◽  
Frédéric Barbut ◽  
...  
Keyword(s):  
Observational Study ◽  
Clinical Cure ◽  
Prospective Observational Study ◽  
Adverse Outcomes ◽  
High Rate ◽  
Clostridioides Difficile ◽  
Real World Setting ◽  
Hospitalised Patients ◽  
Clostridioides Difficile Infection ◽  
Cure Rates

Objective To describe the characteristics, management and outcomes of hospitalised patients with Clostridioides difficile infection (CDI) treated with and without fidaxomicin. Methods This prospective, multicentre, observational study (DAFNE) enrolled hospitalised patients with CDI, including 294 patients treated with fidaxomicin (outcomes recorded over a 3-month period) and 150 patients treated with other CDI therapies during three 1-month periods. The primary endpoint was baseline and CDI characteristics of fidaxomicin-treated patients. Results At baseline, the fidaxomicin-treated population included immunocompromised patients (39.1%) and patients with severe (59.2%) and recurrent (36.4%) CDI. Fidaxomicin was associated with a high rate of clinical cure (92.2%) and low CDI recurrence (16.3% within 3 months). Clinical cure rates were ≥90% in patients aged ≥65 years, those receiving concomitant antibiotics and those with prior or severe CDI. There were 121/296 (40.9%) patients with adverse events (AEs), 5.4% with fidaxomicin-related AEs and 1.0% with serious fidaxomicin-related AEs. No fidaxomicin-related deaths were reported. Conclusions Fidaxomicin is an effective and well-tolerated CDI treatment in a real-world setting in France, which included patients at high risk of adverse outcomes. Trial registration: Description of the use of fidaxomicin in hospitalised patients with documented Clostridium difficile infection and the management of these patients (DAFNE), NCT02214771, www.ClinicalTrials.gov.

scholarly journals Clostridioides difficile Infection in Patients with Chronic Kidney Disease: A Systematic Review

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Adelina Mihaescu ◽  
Arlyn Maria Augustine ◽  
Hassan Tahir Khokhar ◽  
Mohammed Zafran ◽  
Syed Shah Mohammed Emmad Masood ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Antibiotic Use ◽  
Transplant Patients ◽  
Treatment And Prevention ◽  
Clostridioides Difficile ◽  
High Prevalence ◽  
Clostridioides Difficile Infection ◽  
Cure Rates

Clostridioides difficile infection (CDI) is a health issue of utmost significance in Europe and North America, due to its high prevalence, morbidity, and mortality rate. The clinical spectrum of CDI is broad, ranging from asymptomatic to deadly fulminant colitis. When associated with chronic kidney disease (CKD), CDI is more prevalent and more severe than in the general population, due to specific risk factors such as impaired immune system, intestinal dysmotility, high antibiotic use leading to disturbed microbiota, frequent hospitalization, and PPI use. We performed a systematic review on the issue of prevention and treatment of CDI in the CKD population, analysing the suitable randomized controlled cohort studies published between 2000 and 2021. The results show that the most important aspect of prevention is isolation and disinfection with chlorine-based solution and hydrogen peroxide vapour to stop the spread of bacteria. In terms of prevention, using Lactobacillus plantarum (LP299v) proved to be more efficient than disinfection measures in transplant patients, leading to higher cure rates and less recurrent episodes of CDI. Treatment with oral fidaxomycin is more effective than with oral vancomycin for the initial episode of CDI in CKD patients. Faecal microbiota transplantation (FMT) is more effective than vancomycin in recurrent CDI in CKD patients. More large-sample RCTs are necessary to conclude on the best treatment and prevention strategy of CDI in CKD patients.

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 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 Effectiveness of e-cigarettes in smoking cessation: a systematic review and meta-analysis

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
M Oberndorfer ◽  
I Grabovac ◽  
S Haider ◽  
T E Dorner
Keyword(s):  
Systematic Review ◽  
Smoking Cessation ◽  
Meta Analysis ◽  
Current Evidence ◽  
Promising Alternative ◽  
Quality Of Evidence ◽  
Different Populations ◽  
Meta Analyses

Abstract Background Reports of the effectiveness of e-cigarettes (ECs) for smoking cessation vary across different studies making implementation recommendations hard to attain. We performed a systematic review and meta-analysis to synthesise the current evidence regarding the effectiveness of ECs for smoking cessation. Methods PubMed, PsycInfo and Embase databases were searched for randomized controlled trials comparing nicotine ECs with non-nicotine ECs or with established smoking cessation interventions (nicotine replacement therapy (NRT) and or counselling) published between 01/01/2014 and 01/05/2019. Data from eligible studies were extracted and used for random-effects meta-analyses. Results Our literature review yielded 13190 publications with 10 studies being identified as eligible for systematic review, covering 8362 participants, and 8 for meta-analyses (n = 30 - 6006). Using the last follow-up of eligible studies, the proportion of smokers achieving abstinence was 1.67 [95CI:0.99 - 2.81] times higher in nicotine EC users compared to non-nicotine EC users. The proportion of abstinent smokers was 1.69 [95CI:1.25 - 2.27] times higher in EC users compared to participants receiving NRT. EC users showed a 2.70 [95CI:1.15 - 6.30] times higher proportion of abstinent smokers in comparison to participants solely receiving counselling. Conclusions Our analysis showed modest effects of nicotine-ECs compared to non-nicotine ECs. When compared to NRT or counselling, results suggest that nicotine EC may be more effective for smoking cessation. As ECs also help maintaining routinized behaviour and social aspects of smoking, we hypothesise that this may explain their advantage as a tool for smoking cessation. However, given the small number of included studies, different populations, heterogeneous designs, and the overall moderate to low quality of evidence, it is not possible to offer clear recommendations. More comparable data is needed to strengthen confidence in the quality of evidence. Key messages The number of previous studies assessing the effectiveness of ECs for smoking cessation is limited. Further, comparability of these studies is restricted, weakening the quality of evidence. Although current evidence on the effectiveness of ECs for smoking cessation is inconclusive, our meta-analyses suggest that ECs could be a promising alternative tool in attempts to achieve abstinence.

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)

Add-on interventions for the prevention of recurrent Clostridioides Difficile infection: A systematic review and network meta-analysis

Anaerobe ◽  
2021 ◽  
Vol 71 ◽  
pp. 102441
Author(s):  
Paschalis Paschos ◽  
Konstantinos Ioakim ◽  
Konstantinos Malandris ◽  
Argyro Koukoufiki ◽  
Tarek Nayfeh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection

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.

scholarly journals Fecal Microbiota Transplantation: Redefining Surgical Management of Refractory Clostridium difficile Infection

2020 ◽  
Vol 33 (02) ◽  
pp. 092-097 ◽  
Author(s):  
Yao-Wen Cheng ◽  
Monika Fischer
Keyword(s):  
Clostridium Difficile ◽  
Antibiotic Therapy ◽  
Surgical Management ◽  
Salvage Therapy ◽  
Healthy Donor ◽  
Fecal Microbiota Transplantation ◽  
Fecal Microbiota ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection ◽  
Cure Rates

AbstractFecal microbiota transplantation (FMT) is the process of transplanting stool from a healthy donor into the gut of a diseased individual for therapeutic purposes. It has a clearly defined role in the treatment of recurrent Clostridium difficile (reclassified as “Clostridioides difficile”) infection (CDI), with cure rates over 90% and decreased rates of subsequent recurrence compared with anti-CDI antibiotics. There is emerging evidence that FMT is also effective in the treatment of severe and fulminant CDI, with associated decreases in mortality and colectomy rates compared with standard antibiotic therapy. FMT shows promise as salvage therapy for critically-ill CDI patients refractory to maximum medical therapy and not deemed to be surgical candidates. FMT should be considered early in the course of severe CDI and should be delivered immediately in patients with signs of refractory CDI. Expansion of FMT's use along the spectrum of CDI severity has potential to decrease associated rates of mortality and colectomy.

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