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15/05/2014

Vall d'Hebron leads the first clinical trial to test a new drug for Chagas Disease

chagas884

15/05/2014

The study reveals that posaconazole, with great results in animal models, is less effective than the current treatment

The "http://www.nejm.org/doi/full/10.1056/NEJMoa1313122?query=featured_home" New England Journal of Medicine published on May 15 the results of the first clinical trial to test a new drug for Chagas Diseases. Researchers from Vall d'Hebron Institute of Research (VHIR) and the international health program of the Catalan Health institute (PROSICS) led this study which has demonstrated that a new anti-fungal drug, posaconazole, is less effective to heal the disease than the classical treatment with benznidazole.The clinical trial was conducted in two PROSICS centers (Vall d'Hebron-Drassanes and Metropolitana Nord) between September 2010 and August 2011 in 78 patients in the chronic stage of the disease, most of them were originally from Bolivia. These participants were randomly assigned in equal numbers to receive 100-mg posaconazole twice daily, 400-mg posaconazole twice daily, or 150-mg benznidazole twice daily for 60 days. They were followed for 40 weeks after the conclusion of treatment.All patients responded to all the drugs during active treatment, showing negative results on assays to detect T. cruzi DNA from serial blood samples by day 14. However, parasitic DNA began to be detected in many participants after treatment ended, by day 60, and continued to be found throughout follow-up."Posaconazole has shown considerable activity in murine models of acute and chronic Chagas' disease, and this effect was expected to be reproducible in humans, unfortunately, however, only suppressive activity was shown", said Dr. Israel Molina, head of PROSICS and researcher from the Infectious Diseases group. At present, there are only two agents available for treating the chronic form of the disorder - benznidazole and nifurtimox - and both have daunting toxicity profiles. Up to 30% of patients withdraw from these drugs because of adverse events, and their cure rates are unsatisfactory at only 15%-35%.In this first clinical trial participated researchers from the Infectious Diseases Service and research group, led by Dr. Albert Pahissa, and from the Microbiology Service and research group, led by Dr. Tomàs Pumarola. After this clinical trial, they will carry out more through the BERENICE international project.

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