Clinical Trials Logo
  1. Home
  2. Infectious Diseases
  3. NCT02544139
  4. Details
NCT02544139 Clinical Trial

Specificity Study of Diagnostic for Chagas Disease

Infectious Diseases Clinical Trial

Official title:
Determination of Estimated Specificity of Chagas Detect Plus Rapid Tests

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02544139
Other study ID # DSC0227
Secondary ID
Status Completed
Phase N/A
First received September 4, 2015
Last updated August 15, 2017
Start date July 2015
Est. completion date March 2016

Study information
Verified date August 2017
Source InBios International, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. Male and female subjects 18 to 70 years of age

2. Subjects must be able to answer questions concerning:

1. Clinical symptoms

2. Blood transfusions

3. Organ transplants

4. Travel or residence in Chagas endemic areas

Exclusion Criteria:

1. Any subject who knows that they have positive serology for Chagas disease

2. Subjects who are unable to understand verbal of written or oral language of the consent, or require a legal authorized representative for consent.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Chagas Detect Plus

Locations
Country Name City State
United States Johns Hopkins Bloomberg School of Public Health Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
InBios International, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of subjects with negative result one day
See also
  Status Clinical Trial Phase
Completed NCT02763345 - The Added Value of a Mobile Application of Community Case Management on Pediatric Referral Rates in Malawi N/A
Completed NCT00550706 - Drug Utilization Prevalence in a Pediatric Care Medical Center N/A
Completed NCT01033799 - Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers N/A
Completed NCT00761462 - BAY 0 9867 Cipro Pediatric Use Study (QUIP) Phase 3
Completed NCT05088421 - A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of BWC0977 in Healthy Volunteers Phase 1
Completed NCT00828971 - A Study to Assess Efficacy and Safety of IV/PO Moxifloxacin in the Treatment of cSSSIs Phase 3
Completed NCT05468723 - Evaluating Patient Comfort and Environmental Conditions in the Carecube Negative Pressure Isolation Chamber.1
Recruiting NCT02162966 - Safety and Efficacy Study of High Dose Colistin Phase 4
Recruiting NCT00001281 - Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV
Active, not recruiting NCT02654210 - LoewenKIDS - Infections and the Development of the Immune System
Completed NCT02226263 - Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics Phase 2
Terminated NCT00211471 - Treatment of Rubeosis Iridis With Open-Label Anecortave Acetate Sterile Suspension ( 15 mg.). Phase 2
Active, not recruiting NCT04342702 - A Study on the Prospective Cohort Library of COVID-19 in Southeran
Completed NCT02134548 - Sensitivity Study of Diagnostic for Detection of Chagas Infection N/A
Active, not recruiting NCT01611025 - Hospital Microbial Ecology Follow the Introduction of Ertapenem and Other Newly Introduced Antibiotic Over Time N/A
Completed NCT01361997 - Isopropyl Alcohol Against Chlorhexidine - Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination Phase 3
Completed NCT00638677 - Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier Phase 4
Completed NCT02434848 - A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses Phase 2/Phase 3
Completed NCT00276198 - Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants Phase 3
Completed NCT02111564 - A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients Phase 3