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Anti-Parasitic Agent

Short-course Benznidazole for Chagas Disease (BETTY Trial)

Phase 3

Recruiting

Led By Pierre Buekens, MD, PhD

Research Sponsored by Tulane University School of Public Health and Tropical Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 months from the end of the 60d treatment

Awards & highlights

BETTY Trial Summary

This trial will compare a short 30-day treatment with BZN 150mg/day to a 60-day treatment with BZN 300 mg/day in women who are seropositive for T. cruzi and have had a live birth in Argentina. The investigators will follow the women for 10 months after treatment to measure the effect of the two treatments on parasitic load.

Who is the study for?

This trial is for women of reproductive age in Argentina who have had a live birth, are not sterilized, plan to use contraception, and have Chagas disease without prior treatment. They must consent to participate and reside in specific provinces.Check my eligibility

What is being tested?

The study compares two Benznidazole (BZN) treatments for Chagas disease: a short 30-day course with lower dose versus the standard 60-day course with higher dose. The goal is to see if the shorter treatment reduces parasitic load as effectively without increasing serious side effects.See study design

What are the potential side effects?

Potential side effects include those commonly associated with Benznidazole such as skin rashes, digestive disturbances, and neurological symptoms. Serious adverse events could lead to stopping the treatment.

BETTY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 months from the end of the 60d treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 months from the end of the 60d treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 months from the end of the 60d treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Inverse PCR

The frequency of positive PCR and the parasitic load measured by qPCR 10 months after BZN 30d/150mg

Secondary outcome measures

The frequency of serious adverse events leading to treatment interruption of BZN 30d/150mg compared to 60d/300mg immediately after BZN 30d/150mg

Side effects data

From 2015 Phase 2 trial • 120 Patients • NCT01377480

29%

Headache

18%

Nausea

14%

Rash

11%

Abdominal pain upper

11%

Dizziness

11%

Pruritus

11%

Nasopharyngitis

Erythema

Transaminase increased

Vomiting

Arthralgia

Pain in extremity

Hypersensitivity

Photodermatosis

Asthenia

Somnolence

Paraesthesia

Hepatitis

100%

80%

60%

40%

20%

Study treatment Arm

Posaconazole + Benznidazole

Posaconazole

Placebo

Benznidazole + Placebo

BETTY Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 30/150mgExperimental Treatment2 Interventions

The investigators will use a preparation of benznidazole (BZN) that is commercially available in Argentina: Abarax® 100mg and 50mg tablets from ELEA laboratories (Buenos Aires, Argentina). ELEA laboratories will prepare the placebo oral tablets, which will be identical to the drug tablets in aspect and taste. The investigators will purchase the drug and placebo at full cost. Interventions: The BZN short course low dose scheme will be 150 mg per day for 30 days. The drug will be administered orally in two doses per day: the short course treatment will start with the active drug and then placebo oral tablet; one 100 mg tablet and one placebo tablet in the morning and one 50 mg tablet and one placebo tablet in the evening for the first 30 days. The last 30 days will be two placebo tablets in the morning and the evening.

Group II: 60/300mgActive Control1 Intervention

The investigators will use a preparation of benznidazole (BZN) that is commercially available in Argentina: Abarax® 100mg and 50mg tablets from ELEA laboratories (Buenos Aires, Argentina). The investigators will purchase the drug at full cost. Interventions: The standard 60d course will be 300 mg per day, which is similar to the dose used in the second phase of the BENEFIT trial. The drug will be administered orally in two doses per day: the standard course will be one 100mg and one 50mg tablet in the morning and in the evening for 60 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Benznidazole

FDA approved

Placebo Oral Tablet

2017

Completed Phase 4

~2250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San DiegoOTHER

1,121 Previous Clinical Trials

1,520,324 Total Patients Enrolled

Tulane University School of Public Health and Tropical MedicineLead Sponsor

12 Previous Clinical Trials

197,130 Total Patients Enrolled

1 Trials studying Chagas Disease

28,348 Patients Enrolled for Chagas Disease

Institute for Clinical Effectiveness and Health PolicyOTHER

17 Previous Clinical Trials

62,027 Total Patients Enrolled

1 Trials studying Chagas Disease

28,348 Patients Enrolled for Chagas Disease

Media Library

Benznidazole (Anti-Parasitic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03672487 — Phase 3

Chagas Disease Research Study Groups: 30/150mg, 60/300mg

Chagas Disease Clinical Trial 2023: Benznidazole Highlights & Side Effects. Trial Name: NCT03672487 — Phase 3

Benznidazole (Anti-Parasitic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03672487 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When is Benznidazole most likely to produce harmful side effects in patients?

"Benznidazole is classified as a level 3 medication, meaning that while there are some studies supporting its efficacy, multiple rounds of data have shown it to be safe."

Answered by AI

To your knowledge, how many other times has Benznidazole been trialed in a clinical setting?

"There are currently 4 different clinical trials being conducted for Benznidazole. Of these, 3 have advanced to Phase 3. Most of the research is centred in Cochabamba and Cercado, Bolivia; although, there are a total of 20 research sites worldwide."

Answered by AI

Recent research and studies

Reproductive HealthJournal

Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age (BETTY): A Non-inferiority Randomized Controlled Trial Study Protocol

Cafferata, María L., María A. Toscani, Fernando Althabe, Jose M. Belizán, Eduardo Bergel, Mabel Berrueta, Edmund V. Capparelli, et al.. 2020. “Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age (BETTY): A Non-inferiority Randomized Controlled Trial Study Protocol”. Reproductive Health. Springer Science and Business Media LLC. doi:10.1186/s12978-020-00972-1.

clinicaltrials.govStudy

Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age

2019. "Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03672487.