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To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin | Drug | IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy | End of Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response at end of therapy of cleared or improved | End of Therapy | |
| Mucosal response at end of therapy of cleared or improved | End of Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use central contact | Astellas Pharma US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abadia Uberaba | Brazil | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15801925 | Background | de Wet NT, Bester AJ, Viljoen JJ, Filho F, Suleiman JM, Ticona E, Llanos EA, Fisco C, Lau W, Buell D. A randomized, double blind, comparative trial of micafungin (FK463) vs. fluconazole for the treatment of oesophageal candidiasis. Aliment Pharmacol Ther. 2005 Apr 1;21(7):899-907. doi: 10.1111/j.1365-2036.2005.02427.x. | |
| 23959319 |
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| Fluconazole |
| Drug |
IV |
|
|
| Barretos |
| Brazil |
| 5 Sites | Belo Horizonte | Brazil |
| Boqueirao - Santos | Brazil |
| 2 Sites | Campinas | Brazil |
| 2 Sites | Curitiba | Brazil |
| Goiânia | Brazil |
| Maruipe Victoria | Brazil |
| Nova Iguaçu | Brazil |
| Parquelandia - Fortaleza | Brazil |
| Porto Alegre | Brazil |
| Quinta - Natal | Brazil |
| 4 Sites | Rio de Janeiro | Brazil |
| 2 Sites | Salvador | Brazil |
| São José do Rio Preto | Brazil |
| 8 Sites | São Paulo | Brazil |
| 4 Sites | Lima | Peru |
| Arcadia-Pretoria | South Africa |
| Bellville - Cape Town | South Africa |
| 2 Sites | Bloemfontein | South Africa |
| Brits | South Africa |
| Cape Town | South Africa |
| Centurion | South Africa |
| Dundee | South Africa |
| 2 Sites | Durban | South Africa |
| Hatfield - Pretoria | South Africa |
| Johannesburg | South Africa |
| Olifantsfontein | South Africa |
| Paarl | South Africa |
| 2 Sites | Port Elizabeth | South Africa |
| Potchefstroom | South Africa |
| 3 Sites | Pretoria | South Africa |
| Pretoria West | South Africa |
| Reiger Park | South Africa |
| Richards Bay | South Africa |
| Somerset West | South Africa |
| Westdene - Bloemfontein | South Africa |
| Andes DR, Reynolds DK, Van Wart SA, Lepak AJ, Kovanda LL, Bhavnani SM. Clinical pharmacodynamic index identification for micafungin in esophageal candidiasis: dosing strategy optimization. Antimicrob Agents Chemother. 2013 Nov;57(11):5714-6. doi: 10.1128/AAC.01057-13. Epub 2013 Aug 19. |
| ID | Term |
|---|---|
| D002180 | Candidiasis, Oral |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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