BENznidazole Evaluation For Interrupting Trypanosomiasis pilot trial

Not Applicable

Completed

• Conditions: Chagas disease; American trypanosomiasis; Infections and Infestations; Parasitical diseases

• Registration Number: ISRCTN13967269
• Lead Sponsor: Hamilton Health Science Corporation (HHSC) (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-01
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Either sex, aged greater than or equal to 18 and less than or equal to 70 years
2. At least two positive serological tests for Chagas disease (indirect immunofluorescence, indirect hemagglutination, OR Enzyme-Linked Immunosorbent Assay [ELISA]) and at least ONE of the following markers of cardiac involvement (which identify individuals at high risk of progression):
2.1. Abnormal 12 lead Electrocardiogram (ECG): One-major criteria (second or third degree AV block) OR at least two minor criteria:
2.1.1. Any bundle branch block
2.1.2. Any fascicular block
2.1.3. Ventricular premature beats (greater than one)
2.1.4. First degree AV block greater than 220 ms, in the absence of drugs that slow AV node conduction
2.1.5. Mobitz type I AV block, in the absence of drugs that slow AV
2.1.6. Sinus bradycardia less than 50 bpm or sinus pauses greater than 3.0s, in the absence of sinus node blocking drugs
2.1.7. Low voltage of QRS in the frontal plane
2.1.8. Atrial fibrillation
2.2. Increased cardiothoracic ratio greater than 0.50 at baseline on upright chest X ray
2.3. Evidence of regional wall motion abnormality (hypokinesis, akinesis or dyskinesis) or reduced global Left Ventricular Systolic Function (LVEF) less than 50% (2D-Echo Radionuclide Angiography [RNA] LV ventriculography) or increased left ventricular diastolic diameter (greater than 55 mm) on 2D-Echo
2.4. Complex ventricular arrhythmias (multiform greater than 10/hour, couplets or non-sustained Ventricular Tachycardia [NSVT]) on 24 hour ambulatory ECG monitoring

Exclusion Criteria

1. New York Heart Association (NYHA) heart failure class IV or decompensated heart failure
2. Evidence of concomitant Coronary Artery Disease (CAD) or other etiology of dilated cardiomyopathy
3. Previous treatment with antitrypanosomal agents or an accepted indication for antiparasitic therapy (e.g. reactivation of Chagas infection due to immunosuppression by several diseases or treatment with steroids)
4. Patients living in inadequate housing conditions that may predispose to t. cruzi re-infection will not be excluded; instead this condition will be appropriately documented
5. Inability to comply with follow-up
6. History of severe alcohol abuse within two years
7. Known chronic renal insufficiency (serum creatinine greater than 2.5 mg/dl or 200 umol) or hepatic insufficiency (Aspartate Aminotransferase [AST]/Alanine Aminotransferase [ALT] greater than 3 x normal)
8. Pregnancy or breast feeding
9. Megaesophagus with swallowing impairment
10. Other severe disease significantly curtailing life expectancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified