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| Name | Class |
|---|---|
| Hospital Vall d'Hebron | OTHER |
| Tropical Medicine and International Health Unit Drassanes. Barcelona | UNKNOWN |
| International Health Unit Metropolitana Nord. Santa Coloma. | UNKNOWN |
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The investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of Chagas disease chronical infection. Exploratory trial of posaconazole antiparasitic activity against Trypanosoma cruzi.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benznidazole | Active Comparator |
| |
| Posaconazole, low dose | Experimental |
| |
| Posaconazole, high dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benznidazole | Drug | Standard dosage |
| |
| Posaconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Parasitological cure measured by a real time PCR in blood sample | PCR negative at the end of follow up | 12 months after starting treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Parasitological cure measured by real time PCR in blood sample | substained parasitological response | End of treatment, weeks 8, 16, 24 and 40 after treatment |
| Safety and tolerability of both drugs |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Molina Israel, MD | Infectious Disease Department Vall d'Hebron Hospital | Principal Investigator |
| Pahisssa Albert, MD Ph | Infectious Disease Department Vall d'Hebron Hospital | Study Chair |
| Gomez Jordi, MD | International Health Unit Drassanes | Principal Investigator |
| Valerio Lluis, MD | International Health Unit Metropolitana Nord | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Health Unit Metropolitana Nord | Santa Coloma | Barcelona | Spain | |||
| Infectious Disease Department Vall d'Hebron Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24827034 | Derived | Molina I, Gomez i Prat J, Salvador F, Trevino B, Sulleiro E, Serre N, Pou D, Roure S, Cabezos J, Valerio L, Blanco-Grau A, Sanchez-Montalva A, Vidal X, Pahissa A. Randomized trial of posaconazole and benznidazole for chronic Chagas' disease. N Engl J Med. 2014 May 15;370(20):1899-908. doi: 10.1056/NEJMoa1313122. |
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| ID | Term |
|---|---|
| D014355 | Chagas Disease |
| ID | Term |
|---|---|
| D014352 | Trypanosomiasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| C009999 | benzonidazole |
| C101425 | posaconazole |
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| Drug |
|
| First 2 months |
| Barcelona |
| Spain |
| International Health Unit Drassanes | Barcelona | Spain |
| D007239 |
| Infections |
| D000079426 | Vector Borne Diseases |