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According to the Hospital Authority's report, the number of carbapene-producing Enterobacteriaceae cases increased from 36 in 2012 to 134 in 2015. Around 10% of patients treated with MDRO will have clinical infections of the same species. Infections related to these MDRO can cause significant morbidity and high mortality of up to 50%, but there is no validated therapy for MDRO eradication. Studies from anecdotal studies have shown that fecal microbiota transplantation in MDRO human carriers was safe and potentially effective in removing intestinal colonization by several MDRO, including CRE and VRE, even in immunocompromized patients. Therefore, investigators predict that FMT will be safe and potentially useful in eliminating intestinal colonization of CRE and VRE. This is a prospective pilot study to determine whether FMT is safe and effective in eradicating intestinal colonization of CRE and VRE.
Source link: https://clinicaltrials.gov/ct2/show/NCT03479710
Pentaglobin was added to the first-generation antibiotic therapy in neutropenic febrile leukemia or allo-Hematern stem cell transplantation patients colonized by carbapenem-resistant Enterobacteriaceae or some Pseudomonas aeruginosa, with the exception of Pentaglobin in neutropenic febrile acute leukemia or allo-Hematopoietic stem cell transplantation patients colonized by pentaetae Compared to historical controls, the survival of the carriers of intensive chemotherapy or transplant Days of transplant Day varies from 4 months from the start of intense chemotherapy or transplant Days of i. v. , with a 4 month lifespan in carriers not suffering from a bloodstream infection caused by carbapenem-resistant Enterobacteriaceae or Pseudomonas aeruginosa. i. v. increase the overall survival from the start of intensive chemotherapy or transplant Days of transplant Days of transplant Days of transplant days of intensive chemotherapy or transplant Days of hospitalization in patients compared to historical controls in patients with intensive chemotherapy or transplant Days of hospitalization. In the case of neutropenic fever, which is defined as a single oral temperature of u226538. 3°C or a temperature of u2265. 38. 0 cm/u00b0C sustained over a one-hour period, an antibiotic-resistant strain of Carbapenem-resistant Enterobacteriaceae or Pseudomonas aeruginosa carriers, treatment and monitoring of febrile neutropenia in Carbapenem-resistant virus infection ae The early endpoint will be tested at the 0. 3 percent significance level in order to address the multiplicity issue, the Bonferroni method to adjust the significance level will be used as follows: the early endpoint will be tested at the 3. 0% significance level using the Simon phase II study style; the late endpoint will be examined at the 2. 0% significance level. Considering an increase in the Overall Survival from 50% to 90% with 90% confidence at the 2. 0 percent significance level is 68, considering an estimated Overall Survival of 4 months of 70% from the start of intensive care in pre-treatment facilities. Patients included in the research will be monitored by the Data Safety Monitoring Board in 31 evaluable patients to ensure their patient safety. Enrollment may have to stop after the interim study was released after finding 31 bacteremia in 31 patients with CRE or PA, or when the 120th patient is expected to enroll. Each patient with Carbapenem-resistant Enterobacteriaceae or Pseudomonas aeruginosa will have a 30-day sequel to the start of therapy with Pentaglobin.
Source link: https://clinicaltrials.gov/ct2/show/NCT03494959
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