Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole

NCT01162967 — Phase 2, Completed, 78 participants, Hospital Universitari Vall d'Hebron Research Institute

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PROTOCOL FOR PHASE II CLINICAL TRIAL, RANDOMIZED AND OPEN FOR ETIOLOGICAL TREATMENT OF CHRONIC CHAGAS DISEASE WITH POSACONAZOLE AND BENZNIDAZOLE

Registry	NCT01162967, acronym CHAGASAZOL
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	78 (Actual)
Sponsor	Hospital Universitari Vall d'Hebron Research Institute (Other); collaborators: Hospital Vall d'Hebron, Tropical Medicine and International Health Unit Drassanes. Barcelona, International Health Unit Metropolitana Nord. Santa Coloma.
Conditions	Chagas Disease
Interventions	Benznidazole, Posaconazole (Drug)
Dates	start 2010-09-01, primary completion 2012-12-01, completion 2013-03-01, first posted 2010-07-15, last updated 2013-09-10
Locations	3 sites in Spain

-Summary

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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+Arms and interventions

Arm	Type	Interventions
Benznidazole	Active comparator	Drug: Benznidazole
Posaconazole, low dose	Experimental	Drug: Posaconazole
Posaconazole, high dose	Experimental	Drug: Posaconazole

Benznidazole (Drug): Standard dosage
Posaconazole (Drug)

+Outcome measures

Primary outcomes

Parasitological cure measured by a real time PCR in blood sample [12 months after starting treatment]: PCR negative at the end of follow up

Secondary outcomes

Parasitological cure measured by real time PCR in blood sample [End of treatment, weeks 8, 16, 24 and 40 after treatment]: substained parasitological response
Safety and tolerability of both drugs [First 2 months]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Consenting patients with serological evidence of Chagas infection and positive PCR real time

Exclusion Criteria:

\-

+Locations (3)

Facility	City	Country
International Health Unit Metropolitana Nord	Santa Coloma, Barcelona	Spain
Infectious Disease Department Vall d'Hebron Hospital	Barcelona	Spain
International Health Unit Drassanes	Barcelona	Spain

+Publications

Results publication: 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. PMID 24827034

+Investigators

Molina Israel, MD, Principal investigator, Infectious Disease Department Vall d'Hebron Hospital
Pahisssa Albert, MD Ph, Study chair, Infectious Disease Department Vall d'Hebron Hospital
Gomez Jordi, MD, Principal investigator, International Health Unit Drassanes
Valerio Lluis, MD, Principal investigator, International Health Unit Metropolitana Nord