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Completed

NCT Number: NCT01162967

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

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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Key information

Conditions

Chagas Disease Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Trypanosomiasis Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

International Health Unit Metropolitana Nord, Santa Coloma, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Benznidazole

Drug

Standard dosage

Posaconazole

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Safety and tolerability of both drugs

    Time frame: First 2 months

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Hospital Vall d'Hebron
  • International Health Unit Metropolitana Nord. Santa Coloma.
  • Tropical Medicine and International Health Unit Drassanes. Barcelona

Registry information

Official study title

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

Acronym: CHAGASAZOL

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jul 15, 2010
Registry last updated
Sep 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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