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Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease

NCT01678599 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-06-25

No results posted yet for this study

Summary

The purpose of this study is to estimate the gain in sensitivity of several multiple-sample strategies of PCR samples with respect to the current standard (single sample of 10 ml) to detect Chagas chronic stage at baseline and to identify the optimal sampling strategy based on the sensitivity, cost,the completeness of sampling and the acceptability for study patients.

Conditions

  • Chagas Disease

Interventions

DRUG

Benznidazole

All patients participating in this study will be treated with Benznidazole, 5mg/Kg/day PO BID for 60 days with a maximum daily dose of 300mg, as per routine care provided by MSF in rural communities in Aiquile. For patients \> 60 kg, the total dose should be calculated (5mg/Kg x Weight x 60 days) and treatment duration should be adjusted/prolonged accordingly. This treatment is in accordance with the local recommendations from the Ministerio de Salud y Deportes de Bolivia.

Sponsors & Collaborators

  • Medecins Sans Frontieres, Netherlands

    collaborator OTHER

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Lourdes Loza, Biochemist · Medicin Sans Frontièrs

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-12-31
Completion
2013-04-30

Countries

  • Bolivia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01678599 on ClinicalTrials.gov