Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease (LACTNFX)
This study is currently recruiting participants.
Verified December 2012 by Hospital de Niños R. Gutierrez de Buenos Aires
Sponsor:
Hospital de Niños R. Gutierrez de Buenos Aires
Information provided by (Responsible Party):
Facundo Garcia-Bournissen, Hospital de Niños R. Gutierrez de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01744405
First received: December 5, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
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Purpose
The investigators propose to study the transfer of nifurtimox into breastmilk of lactating women who receive the drug for the treatment of Chagas disease.
Breastmilk and blood samples will be obtained from these patients at pre-specified times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer. Estimation of nifurtimox transfer into breastmilk will allow the evaluation of potential degree of exposure of infants breastfed by these women to nifurtimox. This study will help clarify safety of continuing breastfeeding while receiving treatment with nifurtimox for Chagas disease.
| Condition |
|---|
|
Chagas Disease Lactation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease |
Resource links provided by NLM:
Further study details as provided by Hospital de Niños R. Gutierrez de Buenos Aires:
Primary Outcome Measures:
- Nifurtimox concentration in breastmilk and in plasma [ Time Frame: at randomly selected, pre-specified, time points during the 30 days of treatment ] [ Designated as safety issue: No ]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 transfer into breastmilk, if possible.
Secondary Outcome Measures:
- Incidence of adverse drug reactions in women treated with nifurtimox during lactation [ Time Frame: throughout the 30 days of treatment ] [ Designated as safety issue: Yes ]Women receiving treatment with nifurtimox while lactating, enrolled in the study will be followed according to current clinical guidelines, and monitored during the 30 days of treatment (as per Chagas disease treatment guidelines), and monthly for 3 months after treatment completion.
Biospecimen Retention: Samples Without DNA
breastmilk; plasma
| Estimated Enrollment: | 12 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Lactating Women with Chagas disease
Women with Chagas disease who fulfill clinical criteria for treatment with nifurtimox, and who are also lactating
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Population of young women with Chagas disease referred to our center for evaluation and treatment
Criteria
Inclusion Criteria:
- Lactating women with Chagas disease, not treated before
- Use of contraception
Exclusion Criteria:
- History of allergy to nifurtimox 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744405
Contacts
| Contact: Jaime Altcheh, MD | +5411-49624122 | |
| Contact: Facundo Garcia Bournissen, MD PhD | +5411-49624122 | facugb1@hotmail.com |
Locations
| Argentina | |
| Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez | Recruiting |
| Buenos Aires, Argentina, 1425 | |
| Principal Investigator: Jaime Altcheh, MD | |
| Sub-Investigator: Facundo Garcia Bournissen, MD PhD | |
| Sub-Investigator: Samanta Moroni, MD | |
| Sub-Investigator: Guillermo Moscatelli, MD | |
Sponsors and Collaborators
Hospital de Niños R. Gutierrez de Buenos Aires
Investigators
| Principal Investigator: | Facundo Garcia Bournissen, MD PhD | Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET |
More Information
No publications provided
| Responsible Party: | Facundo Garcia-Bournissen, Associate Resesarcher, Hospital de Niños R. Gutierrez de Buenos Aires |
| ClinicalTrials.gov Identifier: | NCT01744405 History of Changes |
| Other Study ID Numbers: | LACT-NIFURTIMOX |
| Study First Received: | December 5, 2012 |
| Last Updated: | December 5, 2012 |
| Health Authority: | Argentina: Human Research Bioethics Committee Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Keywords provided by Hospital de Niños R. Gutierrez de Buenos Aires:
|
Chagas disease lactation breastmilk postpartum period infants |
pediatric clinical pharmacology developmental clinical pharmacology parasitology trypanosoma cruzi nifurtimox |
Additional relevant MeSH terms:
|
Chagas Disease Trypanosomiasis Euglenozoa Infections Protozoan Infections Parasitic Diseases Nifurtimox |
Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013