Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole (CHAGASAZOL)
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ClinicalTrials.gov Identifier: NCT01162967 |
Recruitment Status :
Completed
First Posted : July 15, 2010
Last Update Posted : September 10, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chagas Disease | Drug: Benznidazole Drug: Posaconazole | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 78 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | PROTOCOL FOR PHASE II CLINICAL TRIAL, RANDOMIZED AND OPEN FOR ETIOLOGICAL TREATMENT OF CHRONIC CHAGAS DISEASE WITH POSACONAZOLE AND BENZNIDAZOLE |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | March 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Benznidazole |
Drug: Benznidazole
Standard dosage |
Experimental: Posaconazole, low dose |
Drug: Posaconazole |
Experimental: Posaconazole, high dose |
Drug: Posaconazole |
- Parasitological cure measured by a real time PCR in blood sample [ Time Frame: 12 months after starting treatment ]PCR negative at the end of follow up
- Parasitological cure measured by real time PCR in blood sample [ Time Frame: End of treatment, weeks 8, 16, 24 and 40 after treatment ]substained parasitological response
- Safety and tolerability of both drugs [ Time Frame: First 2 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Consenting patients with serological evidence of Chagas infection and positive PCR real time
Exclusion Criteria:
-

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162967
Spain | |
International Health Unit Metropolitana Nord | |
Santa Coloma, Barcelona, Spain | |
Infectious Disease Department Vall d'Hebron Hospital | |
Barcelona, Spain | |
International Health Unit Drassanes | |
Barcelona, Spain |
Principal Investigator: | Molina Israel, MD | Infectious Disease Department Vall d'Hebron Hospital | |
Study Chair: | Pahisssa Albert, MD Ph | Infectious Disease Department Vall d'Hebron Hospital | |
Principal Investigator: | Gomez Jordi, MD | International Health Unit Drassanes | |
Principal Investigator: | Valerio Lluis, MD | International Health Unit Metropolitana Nord |
Responsible Party: | Hospital Universitari Vall d'Hebron Research Institute |
ClinicalTrials.gov Identifier: | NCT01162967 |
Other Study ID Numbers: |
CHAGASAZOL01 |
First Posted: | July 15, 2010 Key Record Dates |
Last Update Posted: | September 10, 2013 |
Last Verified: | September 2013 |
Chagas Disease Trypanosomiasis Euglenozoa Infections Protozoan Infections Parasitic Diseases Posaconazole Benzonidazole Antifungal Agents Anti-Infective Agents Trypanocidal Agents Antiprotozoal Agents |
Antiparasitic Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors |