UnknownPhase 2

BENDITA BEnznidazole New Doses Improved Treatment and Associations

Bolivia210 participantsStarted 2016-11-30

Plain-language summary

Recent scientific advances have provided further impetus to develop new therapeutic approaches for Chagas Disease (CD) using different doses and duration of BZN, as well as combinations directed at multiple therapeutic targets to improve treatment response and tolerability and reduce the potential for development of resistance. This project focuses on the proof-of-concept evaluation of improved treatment regimens of BZN, with the assessment of new BZN-sparing regimens in monotherapy and in combination with E1224.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Screening criteria * Signed, written informed consent form * Age \>18 to \<50 years * Weight \>50 kg to \<80 kg * Diagnosis of T. cruzi infection by: Conventional serology (a minimum of two positive tests \[Conventional ELISA, Recombinant Elisa and/or Indirect Immunofluorescence (IIF)\]) * Ability to comply with all protocol specified tests and visits and have a permanent address * Patients must be residents of areas free of vectorial transmission (Triatoma infestans). For this protocol, it will be accepted the status of Vectorial Transmission Interruption or Consolidation as per the definition of PAHO/WHO, or the Local Health Program. * No signs and/or symptoms of the chronic cardiac and/or digestive form of CD * No acute or chronic health conditions, that in the opinion of the PI, may interfere with the efficacy and/or safety evaluation of the trial drug (such as acute infections, history of HIV infection, liver and renal disease requiring treatment) * No formal contraindication to BZN (according to the Summary of Product Characteristics) and E1224 (according to the Investigator's Brochure) Note: The contraindications described for Benznidazole and E1224 are essentially hypersensitivity to the active ingredient or any excipient. In the case of hepatic or renal impairment or blood dyscrasia, the medication should only be administered under strict medical supervision. During all the treatment period, the blood count will be monitored, with special attention to leucocytes. Su…

What they're measuring

Parasitological response as determined by serial negative qualitative PCR results (3 negative PCR results, from 3 samples to be collected in the same day) at EOT and sustained parasitological clearance until 6 months follow-up.

Timeframe: From the end of the treatment period up to 6 months.

Trial details

NCT IDNCT03378661

SponsorDrugs for Neglected Diseases

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01-28