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| Name | Class |
|---|---|
| Institute for Clinical Effectiveness and Health Policy | OTHER |
| University of California, San Diego | OTHER |
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The investigators are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short 30-day treatment with BZN 150mg/day (30d/150mg) vs. a 60-day treatment with BZN 300 mg/day (60d/300mg). The investigators will recruit not previously treated T. cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at six months postpartum, and follow them up with the following specific aims:
Specific Aim 1: To measure the effect of BZN 30d/150mg compared to 60d/300mg preconceptional treatment on parasitic load measured by the frequency of positive PCR (primary outcome) and by real-time quantitative PCR (qPCR), immediately (Specific Aim 1a) and 10 months (Specific Aim 1b) after treatment.
Hypothesis 1a: The frequency of positive PCR and the parasitic load measured by qPCR immediately after BZN 30d/150mg will be non-inferior (Non Inferiority [NI] margin for PCR: 10% absolute difference) to BZN 60d/300mg.
Hypothesis 1b: The frequency of positive PCR and the parasitic load measured by qPCR 10 months after BZN 30d/150mg will be non-inferior (NI margin for PCR: 9% absolute difference) to BZN 60d/300mg.
Specific Aim 2: To measure the frequency of serious adverse events leading to treatment interruption of BZN 30d/150mg compared to 60d/300mg.
Hypothesis 2: The frequency of serious adverse events leading to treatment interruption will be 50% lower with BZN 30d/150mg than with BZN 60d/300mg.
A 24-month recruitment period is planned in four hospitals with 23,436 deliveries in 2015 and frequencies of T. cruzi seropositive women varying from 1.5% to 4.8%. The investigators are planning to enroll 600 T. cruzi seropositive women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60/300mg | Active Comparator | 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. |
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| 30/150mg | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benznidazole | Drug | Benznidazole tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Global PCR (Conventional PCR and Real-time Quantitative PCR) Immediately After the End of Treatment. | Number of participants with at least one of the four conventional and/or one of the four quantitative PCR tests positive. | Immediately after the end of treatment: 30 days for the 30-day arm, and 60 days for the 60-day arm. |
| Global PCR (Conventional PCR and Real-time Quantitative PCR) at 10 Months After the End of the 60-day Treatment Period. | Number of participants with at least one of the four conventional and/or one of the four quantitative PCR tests positive. | 10 months after the end of the 60-day treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events and/or Any Adverse Event Leading to Treatment Discontinuation. | Randomization until last visit (10 months after the end of treatment or early termination). | |
| Median Parasitic Load by qPCR Immediately After the End of Treatment in Detectable Samples. |
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Inclusion Criteria:
Exclusion Criteria:
Women of childbearing age
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Buekens, MD, PhD | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Diego | San Diego | California | 92093 | United States | ||
| Tulane School of Public Health and Tropical Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32831069 | Derived | Cafferata ML, Toscani MA, Althabe F, Belizan JM, Bergel E, Berrueta M, Capparelli EV, Ciganda A, Danesi E, Dumonteil E, Gibbons L, Gulayin PE, Herrera C, Momper JD, Rossi S, Shaffer JG, Schijman AG, Sosa-Estani S, Stella CB, Klein K, Buekens P. Short-course Benznidazole treatment to reduce Trypanosoma cruzi parasitic load in women of reproductive age (BETTY): a non-inferiority randomized controlled trial study protocol. Reprod Health. 2020 Aug 24;17(1):128. doi: 10.1186/s12978-020-00972-1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 60/300mg | 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. Benznidazole: Benznidazole tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2018 |
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Placebo
| Placebo Oral Tablet | Drug | Sugar pill manufactured to mimic Benznidazole |
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Parasitic equivalents/mL.
| Immediately after the end of treatment. |
| Median Parasitic Load by qPCR at 10 Months From the End of the 60-day Treatment Period in Detectable Samples | Parasitic equivalents/mL. | 10 months from the end of the 60-day treatment period. |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| Institute for Clinical Effectiveness and Health Policy | Buenos Aires | Argentina |
| FG001 | 30/150mg | 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. Benznidazole: Benznidazole tablet Placebo Oral Tablet: Sugar pill manufactured to mimic Benznidazole |
| COMPLETED |
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| NOT COMPLETED |
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Area of residence categories do not represent mutually exclusive and exhaustive cohorts.
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| ID | Title | Description |
|---|---|---|
| BG000 | 60-day Treatment | 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. Benznidazole: Benznidazole tablet |
| BG001 | 30-day Treatment | 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. Benznidazole: Benznidazole tablet Placebo Oral Tablet: Sugar pill manufactured to mimic Benznidazole |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Place of Residence | Count of Participants | Participants |
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| Endemic Area | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Global PCR (Conventional PCR and Real-time Quantitative PCR) Immediately After the End of Treatment. | Number of participants with at least one of the four conventional and/or one of the four quantitative PCR tests positive. | Intention to treat population. | Posted | Count of Participants | Participants | Immediately after the end of treatment: 30 days for the 30-day arm, and 60 days for the 60-day arm. |
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| Primary | Global PCR (Conventional PCR and Real-time Quantitative PCR) at 10 Months After the End of the 60-day Treatment Period. | Number of participants with at least one of the four conventional and/or one of the four quantitative PCR tests positive. | Intention to treat population | Posted | Count of Participants | Participants | 10 months after the end of the 60-day treatment period. |
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| Secondary | Serious Adverse Events and/or Any Adverse Event Leading to Treatment Discontinuation. | Intention to treat population. | Posted | Count of Participants | Participants | Randomization until last visit (10 months after the end of treatment or early termination). |
| ||||||||||||||||||||||||||||||||
| Secondary | Median Parasitic Load by qPCR Immediately After the End of Treatment in Detectable Samples. | Parasitic equivalents/mL. | Intention to treat population. | Posted | Median | Inter-Quartile Range | Parasitic equivalents/mL | Immediately after the end of treatment. |
| ||||||||||||||||||||||||||||||
| Secondary | Median Parasitic Load by qPCR at 10 Months From the End of the 60-day Treatment Period in Detectable Samples | Parasitic equivalents/mL. | Intention to treat population. | Posted | Median | Inter-Quartile Range | Parasitic equivalents/mL. | 10 months from the end of the 60-day treatment period. |
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Randomization until last visit (10 months after the end of treatment or early termination).
Includes all adverse events, even those not leading to treatment discontinuation. Please note this is different than Outcome 3 (serious adverse events and/or any adverse event leading to treatment discontinuation).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 60/300mg | 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. Benznidazole: Benznidazole tablet | 0 | 44 | 0 | 44 | 32 | 44 |
| EG001 | 30/150mg | 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. Benznidazole: Benznidazole tablet Placebo Oral Tablet: Sugar pill manufactured to mimic Benznidazole | 0 | 43 | 0 | 43 | 31 | 43 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus or erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Headache. dizziness, somnolence | Nervous system disorders | Non-systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment |
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| Blood disorders | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Circulatory | Cardiac disorders | Non-systematic Assessment |
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| Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pierre Buekens | Tulane University Weatherhead School of Public Health | 504-988-8803 | pbuekens@tulane.edu |
| Sep 5, 2018 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014355 | Chagas Disease |
| ID | Term |
|---|---|
| D014352 | Trypanosomiasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000079426 | Vector Borne Diseases |
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| ID | Term |
|---|---|
| C009999 | benzonidazole |
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| Between 18 and 65 years |
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| >=65 years |
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| Non-endemic |
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