NCT01162967

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

2.3 years

First QC Date

May 20, 2010

Last Update Submit

September 9, 2013

Conditions

Chagas Disease

Outcome Measures

Primary Outcomes (1)

  • Parasitological cure measured by a real time PCR in blood sample

    PCR negative at the end of follow up

    12 months after starting treatment

Secondary Outcomes (2)

  • Parasitological cure measured by real time PCR in blood sample

    End of treatment, weeks 8, 16, 24 and 40 after treatment

  • Safety and tolerability of both drugs

    First 2 months

Study Arms (3)

Benznidazole

ACTIVE COMPARATOR
Drug: Benznidazole

Posaconazole, low dose

EXPERIMENTAL
Drug: Posaconazole

Posaconazole, high dose

EXPERIMENTAL
Drug: Posaconazole

Interventions

BenznidazoleDRUG

Standard dosage

Benznidazole
PosaconazoleDRUG
Posaconazole, high dosePosaconazole, low dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

International Health Unit Metropolitana Nord

Santa Coloma, Barcelona, Spain

Location

Infectious Disease Department Vall d'Hebron Hospital

Barcelona, Spain

Location

International Health Unit Drassanes

Barcelona, Spain

Location

Related Publications (1)

  • 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: 24827034DERIVED

MeSH Terms

Conditions

Chagas Disease

Interventions

benzonidazoleposaconazole

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2010

First Posted

July 15, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

September 10, 2013

Record last verified: 2013-09

Locations

ES(3)