Actively Recruiting
Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease
Led by Laboratorio Elea Phoenix S.A. · Updated on 2023-11-30
300
Participants Needed
6
Research Sites
278 weeks
Total Duration
On this page
Sponsors
L
Laboratorio Elea Phoenix S.A.
Lead Sponsor
D
Drugs for Neglected Diseases
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chagas disease, a parasitic infection caused by Trypanosoma cruzi, is endemic in much of Latin America and affects people throughout the world. Currently treatment with the only two drugs effective against the infection, benznidazole and nifurtimox, has significant limitations including frequent adverse effects in adult patients. However, timely treatment is key to achieving global objectives of controlling the disease. The standard treatment has a long duration (60 days). NuestroBen will test the hypothesis that shorter treatment regimens of 14 days and 28 days will be non-inferior to the standard 60-day treatment while improving the safety profile.
CONDITIONS
Official Title
Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Between 18 and 60 years of age
- Weight between 50 kg and 95 kg
- Confirmed diagnosis of Trypanosoma cruzi infection by at least two reactive serology tests
- Positive qualitative PCR test for T. cruzi infection
- Women of childbearing potential must have a negative pregnancy test at inclusion, not be breastfeeding, and use effective contraception during treatment and for 30 days after
- Ability to comply with all exams and protocol visits
- Having a permanent address
- ECG criteria: heart rate 50-100 bpm or isolated sinus bradycardia 41-59 bpm; QRS ≤120 msec; QTc between 350 and 450 msec; non-severe chagasic cardiomyopathy findings allowed
- Normal or minimal structural changes on echocardiogram without severe abnormalities
- No signs or symptoms of moderate to severe chronic cardiac or digestive forms of Chagas disease
- No prior history of mental disorders or suicidal tendencies
- No acute or chronic illnesses that could interfere with study evaluation
- No contraindications to benznidazole
- No history of hypersensitivity or serious adverse reactions to nitroimidazole compounds
- No previous antiparasitic treatment for T. cruzi infection
- No history of drug abuse or alcoholism
- Able to take oral medication
You will not qualify if you...
- Pregnant or intending pregnancy during treatment and 30 days after last dose
- Signs or symptoms of moderate to severe chronic cardiac or digestive Chagas disease or ECG/echocardiographic findings not allowed
- History of cardiomyopathy, heart failure, or severe ventricular arrhythmia
- History of digestive surgery related to Chagas or megacolon/mega-esophagus
- Acute or chronic disease interfering with study evaluation
- Clinically significant abnormal laboratory values per CTCAE v5.0 grade 1
- Conditions preventing oral medication intake
- Known hypersensitivity to nitroimidazole compounds
- History of allergy, asthma, intolerance, or photosensitivity
- Use of allopurinol, antimicrobial/antiparasitic agents, herbal medicines, dietary supplements, or energy drinks
- Scheduled surgery interfering with trial conduct
- Inability to attend visits, comply with treatment, or cooperate
- Previous participation in a T. cruzi treatment trial
- Participation in another trial within 3 months prior to screening
- Serious medical or psychiatric illness increasing risk or interfering with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Instituto Nacional de Parasitología "Dr. Mario Fatala Chaben"
Buenos Aires, Argentina, C1097
Not Yet Recruiting
2
Fundación Huésped
Buenos Aires, Argentina, C1202ABB
Actively Recruiting
3
Hospital Francisco Javier Muñiz
Buenos Aires, Argentina, C1282A
Actively Recruiting
4
Hospital Donación Francisco Santojanni
Buenos Aires, Argentina, C1408INH
Not Yet Recruiting
5
Instituto de Cardiología de Corrientes "Juana Francisca Cabral"
Corrientes, Argentina, W3400
Actively Recruiting
6
Centro de Chagas y Patología Regional, Hospital Independencia
Santiago del Estero, Argentina, G4200
Actively Recruiting
Research Team
C
Carola Lombas, MD
CONTACT
T
Tayná Marques, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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