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NCT01162967 Clinical Trial

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

Chagas Disease Clinical Trial

— CHAGASAZOL  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01162967
Other study ID # CHAGASAZOL01
Secondary ID
Status Completed
Phase Phase 2
First received May 20, 2010
Last updated September 9, 2013
Start date September 2010
Est. completion date March 2013

Study information
Verified date September 2013
Source Hospital Universitari Vall d'Hebron Research Institute
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date March 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Benznidazole
Standard dosage
• Posaconazole

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

Sponsors (4)
Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute Hospital Vall d'Hebron, International Health Unit Metropolitana Nord. Santa Coloma., Tropical Medicine and International Health Unit Drassanes. Barcelona

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Parasitological cure measured by a real time PCR in blood sample PCR negative at the end of follow up 12 months after starting treatment No
Secondary Parasitological cure measured by real time PCR in blood sample substained parasitological response End of treatment, weeks 8, 16, 24 and 40 after treatment No
Secondary Safety and tolerability of both drugs First 2 months Yes
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Completed NCT02386358 - Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Clinical Trial Phase 3
Not yet recruiting NCT05477953 - An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health
Completed NCT02346123 - Determination of Genetic Polymorphisms in Chronic Chagas Cardiomyopathy N/A
Recruiting NCT02295215 - Exercise Training in Patients With Chagasic Heart Disease Without Ventricular Dysfunction N/A
Completed NCT03350295 - Study Will Evaluate the Relative Bioavailability, Safety, and Tolerability of Single Doses of Nifurtimox 30 mg Tablets Exhibiting Different in Vitro Dissolution Characteristics, and to Evaluate the Relative Bioavailability of Nifurtimox 30 mg and 120 mg Phase 1