Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas… (NCT01678599) | Clinical Trial Compass
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 range
18 Years – 60 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
2
- 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.