Prospective Evaluation of Rapid Diagnostic Tests for Trypanosoma Cruzi Infection

NCT07304349 | Recruiting DMC

• 1 other identifier: CH-RDT-009
• Study Type: observational
• Target: 3,234
• Locations: 1 country
• Sites: 4

Brief Summary

Chagas disease (CD) is the most significant endemic zoonosis in Argentina. Two-thirds of affected individuals live in urban areas but only 10% globally are aware of their infection. Diagnosing Chronic Chagas (CCD) requires at least two serological tests, often limited to reference laboratories, creating logistical and economic challenges that delay timely diagnosis and treatment. Although primary health care (PHC) could address most health needs, the availability of Rapid Diagnostic Tests (RDTs) for CCD is limited in endemic countries due to regulatory and commercial barriers. In 2023, in a laboratory evaluation (Instituto Nacional de Parasitología, INP-ANLIS) we demonstrated that performance of six commercial RDTs available in Argentina were similar to reference methods, suggesting their potential for CCD diagnosis use (standard diagnostic", PAHO, 2018). Evaluation of RDTs in field studies across different clinical and epidemiological contexts is mandatory to provide recommendations for their use in CCD diagnosis. In this sense, independent prospective studies should be conducted to evaluate RDTs tests performances using direct blood samples under field conditions in different health care facilities and epidemiological scenarios. Moreover, trials conducted in different countries should be comparable with each other, so this protocol, produced according to STARD 2015 standards, is proposed as a complement to the PAHO (2025) recommendations. These RDT evaluation studies have the ultimate objective of incorporating them into diagnostic algorithms for better access to treatment and care strategy for patients with chronic CD.

Conditions

Chronic Chagas

Keywords

serological diagnosis; diagnostic performance; immunochromatography; neglected tropical diseases

Outcome Measures

Primary Outcomes (1)

• Evaluate the performance of two rapid diagnostic tests (RDTs) to support the treatment of chronic T. cruzi infection. Identify a high-performance diagnostic algorithm that incorporates point-of-care (POC) RDTs.

  Point estimates (with 95% CI) of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of two commercially available T. cruzi RDTs, using the current EC diagnostic algorithm as the reference method. These measures are proportions expressed on a scale ranging from 0 to 1, where higher values indicate better diagnostic performance. To evaluate the overall diagnostic performance of the RDT-based algorithm, Youden's Index (unabbreviated: Youden's Index) will be calculated. Youden's Index is defined as sensitivity + specificity - 1 and is measured on a scale ranging from -1 to +1, where higher values indicate better discriminatory ability.

  From August 2025 to May 2027.

Secondary Outcomes (3)

• Estimate the concordance of RDTs for T. cruzi using different types of samples.

  From August 2025 to April 2027

• Estimate the concordance between the RDTs for T. cruzi and the current diagnostic algorithm for CD.

  from August 2025 to June 2027

• Evaluate the usability of T. cruzi RDTs.

  August 2025 to August 2027

Eligibility Criteria

• Age: 10 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited within the framework of healthcare provision. Participation in the study will be offered to individuals over 10 months of age, or their parents or guardians where applicable, who attend study centres or participate in health promotion activities or territorial testing initiatives organised by INP ANLIS, the Ministry of Health of the Province of Buenos Aires, UNPAZ or UNLaM.

Sponsors & Collaborators

• National Council of Scientific and Technical Research, Argentina: collaborator
• Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben: lead

Study Sites (4)

Hospital Mercante

Buenos Aires, Buenos Aires, 1665, Argentina

RECRUITING

Hospital Gutierrez

Buenos Aires, Buenos Aires, C1425EFD, Argentina

RECRUITING

Hospital Paroissien

Isidro Casanova, Buenos Aires, B1765, Argentina

RECRUITING

Dispositivos Territoriales, Olmos

La Plata, Buenos Aires, 1900, Argentina

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Up to 50 µl capillary blood or ≥1 ml venous blood (EDTA) for RDTs. 3-8 ml venous blood (serum) for reference tests.

MeSH Terms

Conditions

Neglected Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Margarita M. C. Bisio, PhD

  National Council of Scientific and Technical Research, Argentina

  STUDY CHAIR

Central Study Contacts

Rocio Rivero, PhD

CONTACT

+5411 4331-4010; rrivero@anlis.gob.ar

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: August 29, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

AR (4)