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| Name | Class |
|---|---|
| World Health Information Science Consultants, LLC | OTHER |
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This multicenter observational cohort study proposes to establish the risks of short and long-term outcomes in users of parenteral micafungin and in users of other parenteral antifungal agents from 2005 through 2012 with follow-up until 2017.
All eligible patients treated with a parenteral antifungal agent at any time during the years 2005-2012 in each of the participating hospitals, will be included in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1) parenteral micafungin users | patients who had been treated with parenteral micafungin |
| |
| 2) other parenteral antifungal users | patients who had been treated with a parenteral antifungal agent (not micafungin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenteral micafungin application | Drug | Parenteral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent hepatic injury or dysfunction | Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers. | Up to 30 days after termination of the index treatment |
| Treatment-emergent renal failure or dysfunction | Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers. | Up to 30 days after termination of the index treatment |
| Rehospitalization for the parenteral treatment of fungal infections | Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers. | Up to 30 days after termination of the index treatment |
| Death from hepatocellular carcinoma (HCC) | On a long-term basis up to 13 years from 2005-2017. | Up to 13 years after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with parenteral antifungals in tertiary referral centers across the United States.
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| Name | Affiliation | Role |
|---|---|---|
| Lead Investigator | WHISCON, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site US4 | Baltimore | Maryland | 21205 | United States | ||
| Site US2 |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077336 | Caspofungin |
| D000077612 | Anidulafungin |
| D015725 | Fluconazole |
| D017964 | Itraconazole |
| D065819 | Voriconazole |
| D000666 | Amphotericin B |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Other parenteral antifungal drugs |
| Drug |
Parenteral |
|
|
| Boston |
| Massachusetts |
| 02119 |
| United States |
| Site US6 | Ann Arbor | Michigan | 48109 | United States |
| Site US3 | Durham | North Carolina | 27710 | United States |
| Site US5 | Philadelphia | Pennsylvania | 19104 | United States |
| Site US1 | Pittsburgh | Pennsylvania | 15213 | United States |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |