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Chagas Disease clinical trials

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NCT ID: NCT06339710 Not yet recruiting - Clinical trials for Chronic Chagas Disease

Short Benznidazole Regimen for Chronic Phase Chagas Disease Patients

Benlatino
Start date: May 1, 2024
Phase: Phase 3
Study type: Interventional

Multicentric study on Chagas disease that seeks to evaluate a new treatment regimen using the drug benznidazole. Currently, existing treatment regimens are long and have frequent side effects, which leads to a high dropout rate among patients. The research proposes testing two shorter benznidazole regimens to see if they are as effective as standard treatment, but with fewer side effects. The study will have 672 participants and will be carried out in four locations, Bolivia and Colombia. The objective is to analyze the efficacy and safety of new treatment regimens, evaluating the parasitological response in comparison with standard treatment. In addition, an economic assessment will be carried out to analyze direct and indirect costs, including procedures associated with the management of adverse events.

NCT ID: NCT05477953 Not yet recruiting - Chagas Disease Clinical Trials

An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health

Start date: June 30, 2024
Phase:
Study type: Observational

This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied. Chagas disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas disease is left untreated, it can later cause e.g. serious heart and digestive problems. Nifurtimox has been used for more than 50 years to treat Chagas disease in children and adults. It is not recommended to be used during pregnancy as data from animal studies indicate that it may harm the baby. Currently, there are not enough data to know if this is also the case in humans. In this study, researchers want to collect data on the safety of nifurtimox use in pregnant women. To do this, researchers will collect the following information: - Birth defects (abnormal and problematic structures or functions, a child is born with) - Pregnancy outcomes (like live birth, preterm birth, still birth/death of the unborn baby, miscarriage, or abortion) - Certain health problems of the child up to 12 months of age - Certain health problems of the women experienced during pregnancy The data will be collected from different sources including telephone calls with the women or their doctor, CRFs (case reprt forms) or from medical records The researchers will compare the proportion of children with birth defects, pregnancy outcomes or certain health problems of the child or the women during pregnancy with available data on these outcomes in the general population. The study will run for approximately 10 years.