Chagas DiseaseLACTBENZNCT01547533
Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease
An observational study of Chagas Disease and Lactation, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
Trial summary
The investigators propose to study the transfer of benznidazole into breastmilk from the blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk and blood samples will be obtained from these patients at given times after they take the clinically indicated medication, and the… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Chagas Disease, Lactation
- How many people
- 10 participants
- Where
- 1 siteArgentina
- Study dates
- Aug 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: population of young women with Chagas disease referred to our center for evaluation and treatment
Who may be able to join
- Lactating women with Chagas disease, not treated before
- Use of contraception
Who cannot join
- History of allergy to benznidazole or its excipients
- Pregnancy
- Significant heart involvement (due to Chagas disease)
- Significant systemic diseases that could affect the interpretation of the results in the opinion of the principal investigator
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
Buenos Aires, Buenos Aires, 1425
About this study
Official title: Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease
The investigators propose to study the transfer of benznidazole into breastmilk from the blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk and blood samples will be obtained from these patients at given times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer, which in turn will be used to evaluate potential degree of exposure of infants breastfed by these women. This study will help clarify safety of continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.
- Conditions
- Chagas Disease, Lactation
- Keywords
- Chagas disease, lactation, breastmilk, postpartum period, infants, pediatric clinical pharmacology, developmental clinical pharmacology, parasitology, trypanosoma cruzi
- Medical subject headings
- Chagas Disease, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lactating Women with Chagas disease | Women with Chagas disease who fulfill clinical criteria for treatment with benznidazole, and who are also lactating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benznidazole concentration in breastmilk and in plasma
Randomly obtained breastmilk samples will be obtained to both evaluate the breastmilk / plasma concentration ratio of the drug, and to develop a population pharmacokinetics model of drug trasfer into breastmilk, if possible.
Breastmilk concentrations will be used to calculate potential infant exposure through breastmilk to the medication (benznidazole) taken by the mother
Measured: at randomly selected time points during the 30 days of treatment
Secondary outcomes (1)
incidence of adverse drug reactions in women treated with benznidazole during lactation
Women receiving treatment with benznidazole while lactating, enrolled in the study will be followed according to current clinical guidelines, and monitored during the 60 days of the treatment (as per Chagas disease treatment guidelines), and monthly for 3 months after treatment completion.
Measured: throughout the 30 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chagas DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Facundo Garcia-Bournissen, Hospital de Niños R. Gutierrez de Buenos Aires
- Investigators
- Facundo Garcia Bournissen, MD PhD, Principal investigator, Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547533
- Sponsor's protocol ID
- LACT-BENZNIDAZOLE
- Acronym
- LACTBENZ
- Status last verified
- Mar 2015
- First submitted
- 1 Mar 2012
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garcia-Bournissen F, Moroni S, Marson ME, Moscatelli G, Mastrantonio G, Bisio M, Cornou L, Ballering G, Altcheh J. Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease. Arch Dis Child. 2015 Jan;100(1):90-4. doi: 10.1136/archdischild-2014-306358. Epub 2014 Sep 10.
PubMed 25210104
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease
- ClinicalTrials.gov ID
- NCT01547533
- Acronym / sponsor ID
- LACTBENZ / LACT-BENZNIDAZOLE
- Conditions
- Chagas Disease, Lactation
- Keywords
- Chagas disease, lactation, breastmilk, postpartum period, infants, pediatric clinical pharmacology, developmental clinical pharmacology, parasitology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos AiresUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to study the transfer of benznidazole into breastmilk from the blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk and blood samples will be obtained from these patients at given times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer, which in turn will be used to evaluate potential degree of exposure of infants breastfed by these women. This study will help clarify safety of continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactating Women with Chagas disease | – | –Women with Chagas disease who fulfill clinical criteria for treatment with benznidazole, and who are also lactating |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- population of young women with Chagas disease referred to our center for evaluation and treatment
Key inclusion criteria (2 listed)
- Lactating women with Chagas disease, not treated before
- Use of contraception
Key exclusion criteria (4 listed)
- History of allergy to benznidazole or its excipients
- Pregnancy
- Significant heart involvement (due to Chagas disease)
- Significant systemic diseases that could affect the interpretation of the results in the opinion of the principal investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Benznidazole concentration in breastmilk and in plasma
Time frame: at randomly selected time points during the 30 days of treatment
Randomly obtained breastmilk samples will be obtained to both evaluate the breastmilk / plasma concentration ratio of the drug, and to develop a population pharmacokinetics model of drug trasfer into breastmilk, if possible. Breastmilk concentrations will be used to calculate potential infant exposure through breastmilk to the medication (benznidazole) taken by the mother
1 secondary outcome
incidence of adverse drug reactions in women treated with benznidazole during lactation
Time frame: throughout the 30 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Derived from this study: PubMed 25210104Garcia-Bournissen F, Moroni S, Marson ME, Moscatelli G, Mastrantonio G, Bisio M, Cornou L, Ballering G, Altcheh J. Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease. Arch Dis Child. 2015 Jan;100(1):90-4. doi: 10.1136/archdischild-2014-306358. Epub 2014 Sep 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Facundo Garcia Bournissen, MD PhD principal investigator
Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chagas Disease and Lactation, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Benznidazole concentration in breastmilk and in plasma (time frame: at randomly selected time points during the 30 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.