Trial · NCT01678599
Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease
NCT01678599, Phase 4, Completed, Drugs for Neglected Diseases
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease. Trials, record NCT01678599. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01678599
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease
- NCT number
- NCT01678599
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 220 participants, actual
- Lead sponsor
- Drugs for Neglected Diseases
- Conditions
- Chagas Disease
- Interventions
- Benznidazole
- First posted
- 2012-09-05
- Last updated
- 2018-06-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary endpoints are: - A positive or negative PCR at baseline (BL) among serology positive patients. | Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits. | |
| Primary | - Identification of the optimal relationship between sensitivity and feasibility at baseline. | Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits. | For BL and EOT visits, blood samples will be as follows: one initial blood of 10 mL (Sample 1), followed by 1 sample of 5mL collected immediately following (Sample 2); plus one blood sample of 10mL collected 1 week later (Sample 3). Once the optimal strategy has been defined for EOT visit (see section 10.7), this will be the strategy of blood collection to be used at the 6 and 12 months follow-up visits |
| Secondary | - Identification of the optimal relationship between sensitivity and Identification of the optimal relationship between sensitivity and feasibility at End Of Treatment (EOT) | Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits. | |
| Secondary | - The proportion of patients who convert from PCR (+) at baseline to PCR (-) at EOT - to be estimated using 1) the current sampling schedule (CS), the most sensitive one and the optimal one. | Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits. | |
| Secondary | - The proportion of patients who convert from PCR (+) at baseline to PCR (-) at 6 and 12 months follow-up - to be estimated using 1) the current sampling schedule (CS) and the optimal one (based on EOT data). | Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits. | |
| Secondary | - Relative reduction [(parasite count at baseline - parasite count at EOT, 6 and 12 months)/parasite count at baseline] of parasitemia - to be evaluated through parasite load at EOT, 6 and 12 months through quantitative PCR. | Bloods will be at baseline and EOT (last day of treatment +10 + 5 days), 6 months and 12 months follow-up visits. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01678599
GET https://conductscience.org/api/trials/v1/NCT01678599/registered