Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 13 - Any |
| Updated: | 4/6/2019 |
| Start Date: | June 1, 2019 |
| End Date: | May 31, 2023 |
| Contact: | Pierre Buekens, MD, PhD |
| Email: | pbuekens@tulane.edu |
| Phone: | 5049888803 |
Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age: A Non-inferiority Randomized Controlled Trial
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.
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.
Inclusion Criteria:
- Written informed consent from the mother.
- T. cruzi seropositivity confirmed by at least two positive tests.
- Live birth.
Exclusion Criteria:
- Women residing outside of the provinces of Chaco, Santiago del Estero, or Tucumán.
- Previous trypanocide treatment (BZN or nifurtimox).
- Female sterilization; no intention to use modern contraception methods during
treatment.
- Positive pregnancy test.
- History of severe alcohol abuse within two years; renal insufficiency.
We found this trial at
3
sites
Buenos Aires,
Principal Investigator: Fernando Althabe, MD, MSc
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New Orleans, Louisiana 70112
Principal Investigator: Pierre Buekens, MD, PhD
Phone: 504-988-8803
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San Diego, California 92093
Principal Investigator: Edmund Capparelli, PharmD
Phone: 858-246-0009
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