CompletedPhase 4

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

Bolivia220 participantsStarted 2011-04

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The primary endpoints are: - A positive or negative PCR at baseline (BL) among serology positive patients.

Timeframe: Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits.

- Identification of the optimal relationship between sensitivity and feasibility at baseline.

Timeframe: Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits.

Trial details

NCT IDNCT01678599

SponsorDrugs for Neglected Diseases

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

View on ClinicalTrials.gov More Chagas Disease trials

Plain-language summary

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The primary endpoints are: - A positive or negative PCR at baseline (BL) among serology positive patients.

Timeframe: Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits.

- Identification of the optimal relationship between sensitivity and feasibility at baseline.

Timeframe: Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits.