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NCT02544139 · ClinicalTrials.gov registry record
Specificity Study of Diagnostic for Chagas Disease
A clinical trial of Infectious Diseases, sponsored by InBios International.
- Completed
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT02544139 is a study of Infectious Diseases that has completed, run by InBios International. The registered enrollment target is 200 participants, below the 800-participant average among 4 other Infectious Diseases trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02544139, a study of Infectious Diseases, has completed, sponsored by InBios International.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
This study assesses the specificity of Chagas Detect™ Plus (CDP) rapid test versus standard reference tests (e.g. RIPA or IFA) for Chagas diagnosis in the US. The Chagas Detect™ Plus Rapid Test is a rapid immunochromotagraphic strip assay for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum or whole blood samples. Reactive assay results are presumptive evidence of Chagas infection. This study will enroll males and females 18-70 years of age from areas non-endemic for Chagas infection. A fingerprick blood sample and a venous blood sample (for processing to serum) will be collected from each subject. Subject age, gender, and symptoms will be recorded. For this study, samples will have no personally identifiable information. CDP and reference tests will be performed by different operators who are laboratory staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently.
Conditions Studied
Interventions
- OTHER Chagas Detect Plus
Study Locations (1)
Maryland
- Johns Hopkins Bloomberg School of Public Health - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-03 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02544139
The ClinicalTrials.gov registry entry for NCT02544139 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 800-participant average among 4 other Infectious Diseases trials with a reported enrollment target (75% lower). The listed sponsor is InBios International, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Infectious Diseases appearing as the primary indexed condition, and to 1 intervention - of which Chagas Detect Plus is the first listed.
NCT02544139 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02544139 about?
NCT02544139 is a clinical study titled "Specificity Study of Diagnostic for Chagas Disease". This study assesses the specificity of Chagas Detect™ Plus (CDP) rapid test versus standard reference tests (e.g. RIPA or IFA) for Chagas diagnosis in the US. The Chagas Detect™ Plus Rapid Test is a rapid immunochromotagraphic strip assay for the qualitative detection of antibodies to Trypanosoma c...
What is the current status of trial NCT02544139?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2015-07. Estimated completion is 2016-03.
What conditions does trial NCT02544139 study?
This clinical trial studies the following conditions: Infectious Diseases.
What interventions are being tested in trial NCT02544139?
The interventions under investigation include: Chagas Detect Plus (OTHER).
Who is sponsoring clinical trial NCT02544139?
This trial is sponsored by InBios International, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02544139 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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