Trial Outcomes & Findings for Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age (NCT NCT03672487)
NCT ID: NCT03672487
Last Updated: 2026-04-09
Results Overview
Number of participants with at least one of the four conventional and/or one of the four quantitative PCR tests positive.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
87 participants
Primary outcome timeframe
Immediately after the end of treatment: 30 days for the 30-day arm, and 60 days for the 60-day arm.
Results posted on
2026-04-09
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
|
Overall Study
COMPLETED
|
25
|
34
|
|
Overall Study
NOT COMPLETED
|
19
|
9
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
COVID19
|
4
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
60-day Treatment
n=44 Participants
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
|
30-day Treatment
n=43 Participants
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
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=44 Participants
|
2 Participants
n=43 Participants
|
8 Participants
n=87 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=44 Participants
|
41 Participants
n=43 Participants
|
79 Participants
n=87 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=44 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=87 Participants
|
|
Age, Continuous
|
29.6 years
n=44 Participants
|
30.5 years
n=43 Participants
|
30.2 years
n=87 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=44 Participants
|
43 Participants
n=43 Participants
|
87 Participants
n=87 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=44 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=87 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Argentina
|
44 participants
n=44 Participants
|
43 participants
n=43 Participants
|
87 participants
n=87 Participants
|
|
Place of Residence
Urban
|
32 Participants
n=44 Participants
|
31 Participants
n=43 Participants
|
63 Participants
n=87 Participants
|
|
Place of Residence
Rural
|
12 Participants
n=44 Participants
|
12 Participants
n=43 Participants
|
24 Participants
n=87 Participants
|
|
Endemic Area
Endemic
|
26 Participants
n=44 Participants
|
24 Participants
n=43 Participants
|
50 Participants
n=87 Participants
|
|
Endemic Area
Non-endemic
|
18 Participants
n=44 Participants
|
19 Participants
n=43 Participants
|
37 Participants
n=87 Participants
|
PRIMARY outcome
Timeframe: Immediately after the end of treatment: 30 days for the 30-day arm, and 60 days for the 60-day arm.Population: Intention to treat population.
Number of participants with at least one of the four conventional and/or one of the four quantitative PCR tests positive.
Outcome measures
| Measure |
60-day Treatment
n=26 Participants
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
|
30-day Treatment
n=38 Participants
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
|
|---|---|---|
|
Global PCR (Conventional PCR and Real-time Quantitative PCR) Immediately After the End of Treatment.
|
16 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 10 months after the end of the 60-day treatment period.Population: Intention to treat population
Number of participants with at least one of the four conventional and/or one of the four quantitative PCR tests positive.
Outcome measures
| Measure |
60-day Treatment
n=25 Participants
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
|
30-day Treatment
n=34 Participants
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
|
|---|---|---|
|
Global PCR (Conventional PCR and Real-time Quantitative PCR) at 10 Months After the End of the 60-day Treatment Period.
|
14 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Randomization until last visit (10 months after the end of treatment or early termination).Population: Intention to treat population.
Outcome measures
| Measure |
60-day Treatment
n=44 Participants
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
|
30-day Treatment
n=43 Participants
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
|
|---|---|---|
|
Serious Adverse Events and/or Any Adverse Event Leading to Treatment Discontinuation.
|
13 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Immediately after the end of treatment.Population: Intention to treat population.
Parasitic equivalents/mL.
Outcome measures
| Measure |
60-day Treatment
n=17 Participants
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
|
30-day Treatment
n=32 Participants
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
|
|---|---|---|
|
Median Parasitic Load by qPCR Immediately After the End of Treatment in Detectable Samples.
|
NA Parasitic equivalents/mL
No subject with detectable values
|
0.2 Parasitic equivalents/mL
Interval 0.2 to 0.5
|
SECONDARY outcome
Timeframe: 10 months from the end of the 60-day treatment period.Population: Intention to treat population.
Parasitic equivalents/mL.
Outcome measures
| Measure |
60-day Treatment
n=17 Participants
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
|
30-day Treatment
n=31 Participants
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
|
|---|---|---|
|
Median Parasitic Load by qPCR at 10 Months From the End of the 60-day Treatment Period in Detectable Samples
|
0 Parasitic equivalents/mL.
Interval 0.0 to 0.2
|
0 Parasitic equivalents/mL.
Interval 0.0 to 0.0
|
Adverse Events
60/300mg
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
30/150mg
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
60/300mg
n=44 participants at risk
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
|
30/150mg
n=43 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus or erythema
|
47.7%
21/44 • 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).
|
34.9%
15/43 • 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).
|
|
Nervous system disorders
Headache. dizziness, somnolence
|
22.7%
10/44 • 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).
|
18.6%
8/43 • 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).
|
|
Gastrointestinal disorders
Gastrointestinal
|
27.3%
12/44 • 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).
|
25.6%
11/43 • 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).
|
|
Blood and lymphatic system disorders
Blood disorders
|
6.8%
3/44 • 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).
|
11.6%
5/43 • 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).
|
|
Cardiac disorders
Circulatory
|
2.3%
1/44 • 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).
|
2.3%
1/43 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
2.3%
1/44 • 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).
|
2.3%
1/43 • 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).
|
Additional Information
Dr. Pierre Buekens
Tulane University Weatherhead School of Public Health
Phone: 504-988-8803
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place