Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas D… (NCT03587766) | Clinical Trial Compass
CompletedPhase 2
Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas Disease
Spain45 participantsStarted 2017-11-13
Plain-language summary
This study focuses on the evaluation of low doses (600 and 1200 mg) and short treatment duration (at 3, 7 and 10 days) of fexinidazole (Fexi) to determine the minimal efficacious and safe dose for the treatment of adult patients with chronic indeterminate Chagas Disease (CD).
Who can participate
Age range18 Years – 60 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 \< 60 years
* Weight \> 50 kg to \< 90 kg
* Diagnosis of T. cruzi infection by:
* Conventional serology (a minimum of two positive tests \[Conventional ELISA, Recombinant Elisa, Chemiluminescence Immunoassays and/or Indirect Immunofluorescence (IIF)\]
* Ability to comply with all protocol specified tests and visits and have a permanent address
* No signs and/or symptoms of the chronic cardiac and/or digestive form of Chagas Disease (CD) (as per study operating procedures)
* No personal history of mental disability or suicidal tendencies
* 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 FEXI (according to the latest available Investigator's Brochure)
* No history of hypersensitivity, allergic, or serious adverse reactions to any of the "nitro-imidazoles" compound, and/or its components
* No history of CD treatment with BZN, FEXI or Nifurtimox (NFX) at any time in the past
* No history of alcohol abuse or any other drug addiction (as per Study Manual of Operations)
* No condition that prevents patient from taking oral medication
* No concomitant medication with drug known risk of Torsade de Pointe, according AZCERT Scientific Publications and Sudden Arrhythmia Death Syndromes Foun…