Evaluation study of a rapid test and treatments for Chagas disease in Bahia, Brazil

• Conditions: Mass Screening; Drug therapy; C01.920.625

• Registration Number: RBR-5zfkxdy
• Lead Sponsor: Centro de Pesquisas Gonçalo Moniz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-15
• Last Update Posted: 19 August 2024
• Study Completion: 2027-12-20

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Part A: Volunteers residing in the municipalities of Tremedal and Novo Horizonte, Bahia, with active registration in municipal health systems; both genders; and aged over nine months. Part B: Volunteers who tested positive with the Bio-Manguinhos Rapid Chagas Test, along with 10% of those who tested negative; both genders; and aged over nine months. Part C: Volunteers with laboratory-confirmed Chagas disease; both genders; aged under fifty years; and with a normal electrocardiogram (heart rate: 50-100 beats per minute, waves P and R (PR) interval = 200 milliseconds, waves Q, R, and S (QRS) complex = 120 milliseconds, and waves Q and T (QT) interval between 350-450 milliseconds)

Exclusion Criteria

Parts A and B: Volunteers residing in Novo Horizonte or Tremedal, Bahia, who are not registered with the local health systems will be excluded from the study, as will volunteers unable to undergo peripheral blood collection. Part C: Exclusion criteria include volunteers with signs of advanced chronic Chagas disease; diagnosis of HIV/AIDS, mental illness, or suicidal tendencies; any acute or chronic disease deemed contraindicated for treatment by the attending physician; history of alcoholism or drug use; known hypersensitivity to nitroimidazoles; and unavailability to comply with the procedures and visits outlined in the protocol

Study & Design

• Study Type: Observational
• Study Design: Not specified