Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
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drug1665 | Fidaxomicin Wiki | 1.00 |
drug4633 | Vancomycin with Taper/Pulse Wiki | 1.00 |
Name (Synonyms) | Correlation | |
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D003141 | Communicable Diseases NIH | 0.07 |
D007239 | Infection NIH | 0.05 |
Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
The purpose of this study is to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile infection.
Description: The Primary outcome will be sustained clinical response as measured at study day 59 for all treatment regimens. Sustained clinical response is a composite outcome that includes symptom resolution during treatment without any of the following (as assessed on day 59): Diarrhea recurrence Other non-fatal clinical events including severe abdominal pain, toxic megacolon (where diarrhea ceases but is not a beneficial outcome), and colectomy Death
Measure: Determine symptom resolution during treatment without any of the following: diarrhea recurrence; other non-fatal clinical events including severe abdominal pain, toxic megacolon, and colectomy; and death. Time: Day 59 for all treatment regimens.Description: CDI Composite Outcome Measure (CDI-COM) is sustained clinical response without recurrent CDI (defined as diarrhea plus confirmation of toxigenic C. difficile or its toxins in stool) as measured at study day 59 for all three treatment regimens. Sustained response will be defined using the same composite endpoint criteria as were used in the D-COM outcome but without recurrent CDI on or before day 59.
Measure: CDI Composite outcome measure Time: Day 59 for all treatment regimens.Description: Sustained clinical response in Diarrhea Composite Outcome (D-COM) at 28 days post end of therapy
Measure: Diarrhea Composite outcome measure Time: Day 38 since randomization for vancomycin and fidaxomicin, day 59 since randomization for vancomycin followed by tapering and pulse dose regimenDescription: Sustained clinical response in Diarrhea Composite Outcome (D-COM) at 90 days post randomization
Measure: Diarrhea Composite outcome measure Time: Day 90 since randomizationDescription: Sustained clinical response in CDI Composite Outcome (CDI-COM) at 28 days post end of therapy. Sustained response in CDI-COM is defined using the same composite endpoint criteria as was used in the D-COM composite outcome (primary outcome) but with confirmation of no CDI recurrence by a negative C. difficile stool assay test.
Measure: CDI Composite outcome measure Time: Day 38 since randomization for vancomycin and fidaxomicin, day 59 since randomization for vancomycin followed by tapering and pulse dose regimenDescription: Sustained clinical response in CDI Composite Outcome (CDI-COM) at 59 days post randomization
Measure: CDI Composite outcome measure Time: Day 59 since randomizationDescription: Sustained clinical response in CDI Composite Outcome (CDI-COM) at 90 days post randomization
Measure: CDI Composite outcome measure Time: Day 90 since randomizationDescription: Proportion of subjects with symptom resolution by day 10
Measure: Symptom resolution Time: Day 10 since randomizationDescription: Days from randomization to symptom resolution
Measure: Symptom resolution Time: Day 10 since randomizationDescription: Diarrhea recurrence following initial symptom resolution
Measure: Symptom resolution Time: Day 90 since randomizationDescription: Diarrhea recurrence with confirmation of recurrent CDI following initial symptom resolution
Measure: Diarrhea recurrence Time: Day 90 since randomizationDescription: Change in patient reported C.diff Health Related Quality of Life (HRQOL) from baseline (day 0) to day 10
Measure: C.diff Health Related Quality of Life (HRQOL) Time: Day 90 since randomizationDescription: Change in patient reported C.diff Health Related Quality of Life (HRQOL) from baseline (day 0) to day 59
Measure: C.diff Health Related Quality of Life (HRQOL) Time: Day 90 since randomizationDescription: Sustained clinical response (D-COM) at day 59 for subgroups (infection with the BI/NAP1/027 strain (yes, no) at study enrollment; etc.)
Measure: Sustained clinical response (D-COM) Time: Day 59 since randomizationDescription: Sustained clinical response (CDI-COM) at day 59 for subgroups (infection with the BI/NAP1/027 strain (yes, no) at study enrollment; etc.)
Measure: Sustained clinical response (CDI-COM) Time: Day 59 since randomizationAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports