Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease
- Registration Number
- NCT04024163
- Lead Sponsor
- Insud Pharma
- Brief Summary
This study evaluate the efficacy and safety of benznidazole in the treatment of chronic indeterminate Chagas disease in children. All subjects will receive benznidazole and results will be compared to historically to a placebo arm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 178
- Age between 2 years and 18 years (age limits inclusive)
- Diagnosis of Trypanosoma cruzi (T. cruzi) infection by conventional serology based on positive ELISA and at least 1 other positive conventional serology test (recombinant ELISA or IIF)
- Written informed consent by parent/legal representative and informed assent from patients if >7 years old when applicable (as requirements may vary by country and by site)
- Females of childbearing potential (ie, female patients who have experienced menarche) and male patients must agree to use highly effective contraception if sexually active from the time of signing of the informed consent/assent form until ≥5 days after the last dose of study treatment
- Pregnant or intending to become pregnant during treatment and within 5 days after the last dose of study treatment
- Patient presenting any other acute or chronic health conditions, which in the opinion of the Principal Investigator (PI), may interfere with the pharmacokinetic (PK), efficacy, and/or safety evaluation of the study treatment
- Signs and/or symptoms of acute Chagas Disease
- Known history of hypersensitivity or serious adverse reactions to nitroimidazoles
- History of Chagas Disease treatment with Benznidazole (BZN) or nifurtimox
- Immunocompromised (clinical history compatible with human immunodeficiency virus (HIV) infection, primary immunodeficiency, or prolonged treatment with corticosteroids or other immunosuppressive drugs)
- Abnormal laboratory test values (as per protocol-specified ranges) at Screening for the following parameters: total white blood cell (WBC) count, platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and creatinine
- Abnormal ECG (as per protocol-specified ranges) and/or any Chagas disease associated findings
- Any condition that prevents the patient from taking oral medication
- Patient is known to or suspected of not being able to comply with the study protocol and the use of the investigational medicinal product (IMP)
- Evidence or history of alcohol or drug abuse (within the last 12 months)
- Any planned procedure that may interfere with highly effective contraception during treatment and within 5 days after the last dose of study treatment
- Employee of the Investigator or trial centre, or family member of the employees or the Investigator
- Any condition that, in the opinion of the Investigator, may jeopardise the trial conduct according to the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Benznidazole Benznidazole Benznidazole 100 mg Tablets or Benznidazole 12.5 mg Tablets by mouth, every 12 hours for 60 days
- Primary Outcome Measures
Name Time Method Serological Cure by Conventional ELISA 72-month follow up Percentage of patients with negative conventional ELISA results as a measure of serological cure at the end of the 72-month follow up
- Secondary Outcome Measures
Name Time Method Serological Cure by Conventional ELISA at different timepoints Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up Percentage of patients with negative conventional ELISA results as a measure of serological cure
Serological Cure by two conventional serology tests at 72 month 72 months of follow-up Percentage of patients with two negative conventional serology results as a measure of serological cure
Serological Cure by two conventional serology tests at 48 months 48 months of follow-up Percentage of patients with two negative conventional serology results as a measure of serological cure
Serological Cure by three serology tests at different timepoints Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up Percentage of patients with three negative serology results as a measure of serological cure
Serological Cure by Non-Conventional ELISA at different timepoints Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up Percentage of patients with negative non-conventional ELISA (F29) results as a measure of serological cure
Cure by qPCR at different timepoints Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up Consistently negative quantitative polymerase chain reaction (qPCR) results as a surrogate measure of cure
Progression of clinical disease at different timepoints Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up Percentage of patients with progression to clinical disease over the period of follow-up
Serological titres reduction at different timepoints Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up Reduction of conventional and nonconventional serological titres over the period of follow-up
Progression of clinical disease and serological cure by one assay at different timepoints 48 and 72 months of follow-up Percentage of patients with no evidence of established cardiomyopathy over the period of follow-up and seroconversion to negative by one assay
Progression of clinical disease and serological cure by two assays at different timepoints 48 and 72 months of follow-up Percentage of patients with no evidence of established cardiomyopathy over the period of follow-up and seroconversion to negative by two assay
Trial Locations
- Locations (9)
Fundación Salud para el Trópico
🇨🇴Santa Marta, Colombia
Centro de Atención e Investigación Médica (CAIMED)
🇨🇴Yopal, Colombia
Hospital "Luis Carlos Lagomaggiore"
🇦🇷Mendoza, Argentina
Hospital de Ninos "Dr. Ricardo Gutierrez"
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Hospital Pediatrico "Dr. Humberto Notti"
🇦🇷Mendoza, Argentina
Hospital Público Descentralizado Dr. Guillermo Rawson
🇦🇷San Juan, Argentina
Antigua Hospital Viedma
🇧🇴Cochabamba, Bolivia
CEADES - Plataforma de Chagas Sucre
🇧🇴Sucre, Bolivia
Centro de Enfermedad de Chagas y Patologías Regionales
🇦🇷Santiago Del Estero, Argentina