Assessment of Therapeutic Response to Benznidazole in patients with Chronic Chagas Disease.

Active, not recruiting

• Conditions: Chagas disease; MedDRA version: 14.0Level: LLTClassification code 10008384Term: Chagas' diseaseSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2011-002022-41-ES
• Lead Sponsor: Fundación para la Investigación Biomédica del Hospital Ramón y Cajal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

?Participant willing and able to give informed consent for participation in the study
?Ability to understand study procedures and to comply with them for the entire length of the study
?Men and women, more than 20 and less than 50 years old with asymptomatic chronic Chagas disease
?No urgent need for benznidazole therapy
?Detectable T. cruzi in blood (positive qualitative PCR)
?For women of childbearing age an effective contraceptive method must be used during the treatment period and in the month following treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Symptomatic acute or chronic Chagas disease
?Current pregnancy
?Previous therapy with benznidazole, nifurtimox or any other tripanocidal drug
?Severe hepatic or renal impairment
?Inability to give written informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified