scholarly journals Does Adjunctive Tigecycline Improve Outcomes in Severe-Complicated, Nonoperative Clostridium difficile Infection?

2017 ◽  
Vol 4 (1) ◽  
Author(s):  
Mary T. LaSalvia ◽  
Westyn Branch-Elliman ◽  
Graham M. Snyder ◽  
Monica V. Mahoney ◽  
Carolyn D. Alonso ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Surgical Intervention ◽  
Small Sample Size ◽  
Severity Of Illness ◽  
Small Sample ◽  
High Rate ◽  
Limited Power ◽  
Severe Clostridium Difficile Infection ◽  
To Receive

Abstract Severe Clostridium difficile infection is associated with a high rate of mortality; however, the optimal treatment for severe- complicated infection remains uncertain for patients who are not candidates for surgical intervention. Thus, we sought to evaluate the benefit of adjunctive tigecycline in this patient population using a retrospective cohort adjusted for propensity to receive tigecycline. We found that patients who received tigecycline had similar outcomes to those who did not, although the small sample size limited power to adjust for comorbidities and severity of illness.

scholarly journals Clearance of Vancomycin-Resistant Enterococcus Concomitant With Administration of a Microbiota-Based Drug Targeted at Recurrent Clostridium difficile Infection

2016 ◽  
Vol 3 (3) ◽  
Author(s):  
Erik R. Dubberke ◽  
Kathleen M. Mullane ◽  
Dale N. Gerding ◽  
Christine H. Lee ◽  
Thomas J. Louie ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Small Sample Size ◽  
Secondary Analysis ◽  
Small Sample ◽  
Vancomycin Resistant Enterococcus ◽  
Recurrent Clostridium Difficile Infection ◽  
Stool Samples ◽  
Vancomycin Resistant

Abstract Background.  Vancomycin-resistant Enterococcus (VRE) is a major healthcare-associated pathogen and a well known complication among transplant and immunocompromised patients. We report on stool VRE clearance in a post hoc analysis of the Phase 2 PUNCH CD study assessing a microbiota-based drug for recurrent Clostridium difficile infection (CDI). Methods.  A total of 34 patients enrolled in the PUNCH CD study received 1 or 2 doses of RBX2660 (microbiota suspension). Patients were requested to voluntarily submit stool samples at baseline and at 7, 30, and 60 days and 6 months after the last administration of RBX2660. Stool samples were tested for VRE using bile esculin azide agar with 6 µg/mL vancomycin and Gram staining. Vancomycin resistance was confirmed by Etest. Results.  VRE status (at least 1 test result) was available for 30 patients. All stool samples for 19 patients (63.3%, mean age 61.7 years, 68% female) tested VRE negative. Eleven patients (36.7%, mean age 75.5 years, 64% female) were VRE positive at the first test (baseline or 7-day follow-up). Of these patients, 72.7%, n = 8 converted to negative as of the last available follow-up (30 or 60 days or 6 months). Of the other 3: 1 died (follow-up data not available); 1 patient remained positive at all follow-ups; 1 patient retested positive at 6 months with negative tests during the interim. Conclusions.  Although based on a small sample size, this secondary analysis demonstrated the possibility of successfully converting a high percentage of VRE-positive patients to negative in a recurrent CDI population with RBX2660.

scholarly journals LB12. Safety and Efficacy of Fidaxomicin and Vancomycin in Pediatric Patients with Clostridium difficile Infection: Phase III, Multicenter, Investigator-blind, Randomized, Parallel Group (SUNSHINE) Study

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S763-S764 ◽  
Author(s):  
Joshua Wolf ◽  
Krisztina Kalocsai ◽  
Claudia Fortuny ◽  
Stefan Lazar ◽  
Samantha Bosis ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Antibiotic Treatment ◽  
Clostridium Difficile Infection ◽  
Financial Support ◽  
Small Sample Size ◽  
Medical Writing ◽  
Small Sample ◽  
Phase Iii ◽  
Watery Diarrhea ◽  
Safety And Efficacy

Abstract Background Clostridium difficile infection (CDI), a common cause of antibiotic-associated diarrhea, leads to substantial healthcare burden. In children and young adults, the incidence of CDI is increasing. Fidaxomicin (FDX) is a narrow-spectrum macrocyclic antibiotic treatment for CDI in adults, but pediatric data are limited. The primary objective of our study was to investigate safety and efficacy of FDX and vancomycin (VAN) in children. Methods Patients aged <18 years with new laboratory-confirmed CDI and diarrhea (watery diarrhea for patients aged <2 years, and ≥3 unformed bowel movements in 24 hours for patients aged ≥2 years) were enrolled in a randomized, investigator-blinded study. Participants were randomized (2:1) to 10 days of treatment with either FDX (oral suspension 32 mg/kg/day or tablets 200 mg BID) or VAN (oral liquid 40 mg/kg/day or capsules 125 mg QID). Concurrent use of other antibiotic treatment for CDI was not permitted. Randomization was stratified by age group. The primary efficacy endpoint was confirmed clinical response (CCR) at Day 12 (absence of diarrhea for 2 consecutive days on treatment and remaining well until treatment discontinuation). Other efficacy endpoints were also evaluated. Results Of 142 patients in the full analysis set (FDX n = 98; VAN n = 44), 30 were aged <2 years, 48 were aged 2 to <6 years, 36 were aged 6 to <12 years and 28 were aged 12 to <18 years. At baseline, 28.6% of the FDX arm and 22.7% of the VAN arm had prior confirmed CDI. Overall, 73.5% of the FDX arm and 75.0% of the VAN arm had ≥1 treatment-emergent adverse event. There were three deaths in the FDX arm during the study and two deaths in the VAN arm after end of study (post-Day 40); none were related to treatment. There was a trend to improved CCR and other efficacy outcomes for FDX (figure) and this was statistically significant for global cure (adjusted difference 18.8%; 95% CI 1.5%, 35.3%). Conclusions There was a consistent trend for improved efficacy outcomes with FDX compared with VAN, as shown by the adjusted treatment differences, although the small sample size precluded conclusions on most outcome differences. Figure. Disclosures J. Wolf, Astellas Pharma: Consultant and Non-Financial Support, Consulting fee and This study was initiated and sponsored by Astellas. Medical writing support was provided by Cello Health MedErgy and funded by Astellas. . K. Kalocsai, Astellas Pharma: Non-Financial Support, This study was initiated and sponsored by Astellas. Medical writing support was provided by Cello Health MedErgy and funded by Astellas. . C. Fortuny, Astellas Pharma: Non-Financial Support, This study was initiated and sponsored by Astellas. Medical writing support was provided by Cello Health MedErgy and funded by Astellas. . S. Lazar, Astellas Pharma: Non-Financial Support, This study was initiated and sponsored by Astellas. Medical writing support was provided by Cello Health MedErgy and funded by Astellas. . S. Bosis, Astellas Pharma: Non-Financial Support, This study was initiated and sponsored by Astellas. Medical writing support was provided by Cello Health MedErgy and funded by Astellas. . B. Korczowski, Astellas Pharma: Non-Financial Support, This study was initiated and sponsored by Astellas. Medical writing support was provided by Cello Health MedErgy and funded by Astellas. . A. Petit, Astellas Pharma: Non-Financial Support, This study was initiated and sponsored by Astellas. Medical writing support was provided by Cello Health MedErgy and funded by Astellas. . D. Bradford, Astellas Pharma: Employee and Non-Financial Support, Medical writing support was provided by Cello Health MedErgy and funded by Astellas. and Salary. E. Incera, Astellas Pharma: Employee of Iqvia, a CRO contracted by Astellas, Medical writing support was provided by Cello Health MedErgy and funded by Astellas. . J. Melis, Astellas Pharma: Employee and Non-Financial Support, Medical writing support was provided by Cello Health MedErgy and funded by Astellas. and Salary. R. Van Maanen, Astellas Pharma: Employee and Non-Financial Support, Medical writing support was provided by Cello Health MedErgy and funded by Astellas. and Salary.

Risk Factors and Outcomes Associated With Severe Clostridium difficile Infection in Children

2012 ◽  
Vol 31 (2) ◽  
pp. 134-138 ◽  
Author(s):  
Jason Kim ◽  
Julia F. Shaklee ◽  
Sarah Smathers ◽  
Priya Prasad ◽  
Lindsey Asti ◽  
...  
Keyword(s):  
Risk Factors ◽  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Severe Clostridium Difficile Infection

scholarly journals Genetic determinants of trehalose utilization are not associated with severe Clostridium difficile infection

2019 ◽  
Author(s):  
Katie Saund ◽  
Krishna Rao ◽  
Vincent B. Young ◽  
Evan S. Snitkin
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Case Control Study ◽  
Severe Infection ◽  
Case Control ◽  
Genetic Determinants ◽  
Severe Clostridium Difficile Infection ◽  
Control Study

ABSTRACTIn a case-control study of patients with C. difficile infection we found no statistically significant association between the presence of trehalose utilization variants in infecting C. difficile strains and development of severe infection. These results do not support trehalose utilization conferring enhanced virulence in the context of human C. difficile infections.

scholarly journals Randomized Double-blind Placebo-controlled Proof-of-concept Trial of Resveratrol for Outpatient Treatment of Mild Coronavirus Disease (COVID-19)

2021 ◽  
Author(s):  
Marvin R. McCreary ◽  
Patrick M. Schnell ◽  
Dale A. Rhoda
Keyword(s):  
Pulmonary Embolism ◽  
Adverse Events ◽  
Small Sample Size ◽  
Primary Outcome Measure ◽  
Small Sample ◽  
Double Blind ◽  
Phase 2 Study ◽  
Clinically Significant ◽  
Low Incidence ◽  
To Receive

Abstract Resveratrol is a polyphenol that has been well studied and has demonstrated anti-viral and anti-inflammatory properties that might mitigate the effects of COVID-19. Outpatients (N=105) were recruited from central Ohio in late 2020. Participants were randomly assigned to receive placebo or resveratrol. Both groups received a single dose of Vitamin D3 which was used as an adjunct. The primary outcome measure was hospitalization within 21 days of symptom onset; secondary measures were ER visits, incidence of pneumonia and pulmonary embolism. Five patients chose not to participate after randomization. Twenty-one day outcome was determined of all one hundred participants (mean [SD] age 55.6 [8.8] years; 61% female) (or their surrogates). There were no clinically significant adverse events attributed to resveratrol. Outpatients in this phase 2 study treated with resveratrol had a lower incidence compared to placebo of: hospitalization (2% vs. 6%, RR 0.33, 95% CI 0.04-3.10), COVID-related ER visits (8% vs. 14%, RR 0.57, 95% CI 0.18-1.83), and pneumonia (8% vs. 16%, RR 0.5, 95% CI 0.16-1.55). One patient (2%) in each group developed pulmonary embolism (RR 1.00, 95% CI: 0.06-15.55). This underpowered study was limited by small sample size and low incidence of primary adverse events. A larger trial could determine efficacy.TRIAL REGISTRATIONS: ClinicalTrials.gov NCT04400890 26/05/2020; FDA IND #150033 05/05/2020

scholarly journals Derivation and Validation of a Clinical Prediction Tool for Severe Clostridium difficile Infection

2011 ◽  
Vol 140 (5) ◽  
pp. S-326-S-327 ◽  
Author(s):  
Xi Na ◽  
Alan J. Martin ◽  
Daniel A. Leffler ◽  
Sarah L. Flores ◽  
Kyne Lorraine ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Prediction Tool ◽  
Clinical Prediction ◽  
Severe Clostridium Difficile Infection ◽  
Clinical Prediction Tool
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