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To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Daily dose |
|
| 2 | Active Comparator |
| |
| 3 | Experimental | Every other day dose, alternating with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micafungin | Drug | IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparative incidence of success, defined as complete clearing of esophageal lesions | End of Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall therapeutic response | End of Therapy | |
| Mycological response | End of Therapy | |
| Clinical response |
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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 |
|---|---|---|---|---|---|---|
| 5 Sites | Buenos Aires | Argentina | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23959319 | Derived | 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. |
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| caspofungin | Drug | IV |
|
| End of Therapy |
| Córdoba |
| Argentina |
| Neuquén | Argentina |
| Santa Fe | Argentina |
| Barretos | Brazil |
| 3 Sites | Belo Horizonte | Brazil |
| Boqueirao-Santos | Brazil |
| Campinas | Brazil |
| 2 Sites | Curitiba | Brazil |
| Nova Iguaçu | Brazil |
| Parquelandia-Fortaleza | Brazil |
| 7 Sites | São Paulo | Brazil |
| 4 Sites | Lima | Peru |
| Gaborone | Botswana | South Africa |
| Windoek | Nambia | South Africa |
| Arcadia-Pretoria | South Africa |
| Benoni | South Africa |
| 2 Sites | Bloemfontein | South Africa |
| Cape Town | South Africa |
| Centurion | South Africa |
| Dundee | South Africa |
| Durban | South Africa |
| Hatfield-Pretoria | South Africa |
| Olifantsfontein | South Africa |
| 2 Sites | Port Elizabeth | South Africa |
| Potchefstroom | South Africa |
| Pretoria | South Africa |
| Pretoria West | South Africa |
| Reiger Park | South Africa |
| Richards Bay | South Africa |
| Somerset West | South Africa |
| 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 |
| D000077336 | Caspofungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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