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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases
• Collaborator: Medecins Sans Frontieres, Netherlands
• Treatments: Benzonidazole

Criteria

Inclusion Criteria:

• Age between > 18 - 60 years

• Diagnosis of T. cruzi infection by Chagas serology. Two out of three serological tests must be positive [conventional ELISA, recombinant ELISA, or HAI)

• Written informed consent form

Exclusion Criteria:

• Women in reproductive age who have a positive pregnancy test at screening, or who are breastfeeding Note: Women in reproductive age must accept to use a contraceptive method during the entire treatment phase of the trial

• Current presentation of serious health condition such as: active pulmonary tuberculosis and clinical signs of liver or renal failure.

• Chagasic cardiomyopathy stage II, III and IV (according to the NYHA classification)

• Subjects requiring pacemaker implantation or other serious cardiac conduction defects

• History of CD treatment with benznidazole or nifurtimox at any time in the past

• Inability to comply with follow-up and/or not having a permanent address

• History of alcohol abuse or any other drug addiction