Clinical Trial: Sub Arachnoid Neurocysticercosis Treatment Outcome (SANTO)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Randomized Trial of Combined Albendazole Plus Praziquantel for Subarachnoid Cysticercosis of the Sylvian Fissure or the Basal Cisterns

Brief Summary: Taenia solium neurocysticercosis (NCC) is a parasitic infection causing much neurological disease in most of the world. When parasites locate in the cavities around the brain (subarachnoid NCC, SANCC), it becomes an aggressive, progressive and frequently lethal presentation. Current treatment regimens for SANCC have quite limited efficacy. The investigators propose to compare the current standard of care (a single antiparasitic drug, albendazole) with a combined regimen using two antiparasitic drugs simultaneously by adding praziquantel. The trial will enrol 164 patients in four centers, two in Peru, one in Ecuador, and one in Brasil.

Detailed Summary:

Double-blind, randomized, placebo-controlled study in patients with subarachnoid cysticercosis of the basal cisterns or the Sylvian fissure, comparing in two parallel arms the efficacy of the standard of care anti-parasitic regime (30 days of ABZ at 15 mg/k/d, up to 1200 mg/k/d) with a combined regime using similar doses of ABZ and adding PZQ at 50 mg/k/d for the initial 15 days of anti-parasitic treatment. The study and interim analysis plan are designed to allow direct, concrete efficacy comparison in this deadly type of NCC while minimizing the risks of disease progression in the standard of care arm.

In short, this is a parallel group study with a dichotomous primary outcome variable. The main analysis will compare the proportions of patients obtaining the primary outcome at 6 months, using a Chi-square test in a bivariate analysis. A similar analysis will be used for the proportions of patients with a good clinical outcome, and the proportions of patients in whom lesion resolution sustains when assessed at month 12. A Student T test analysis will be used to compare for reduction in parasite volume and non-parametric Mann-Whitney test will be alternatively applied for non-normally distributed data. A non-parametric Spearman's Rho test will be used to assess the correlation between the proportions of cyst mass reduction with the decrease in antigen levels in each study group. A Chi-square test in a bivariate analysis will evaluate the association between negative antigen levels at 6 months versus the complete disappearance of cyst mass.


Sponsor: Universidad Peruana Cayetano Heredia

Current Primary Outcome: Radiological efficacy at three months (3-month improvement). [ Time Frame: Day 90 +/- 15 days ]

Thirty percent or greater decrease in the combined volume of all parasitic masses, evaluated by contrast-enhanced MRI 3 months after therapy onset, and recorded both as a dichotomous outcome and as a continuous quantification.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Radiological efficacy at six months (marked improvement or "radiological cure") (evaluated only in patients with improvement at month 3). [ Time Frame: Day 180 +/- 15 days ]
    Total disappearance or greater than 50% decrease in the combined volume of subarachnoid parasites, evaluated by contrast-enhanced MRI 6 months after therapy onset, and recorded both as a dichotomous outcome and as a continuous quantification. three.months after treatment onset (comparative between treatment arms).
  • Effect persistence at 12 months (no relapse) (evaluated only in patients with marked improvement at month 6) Effect persistence at 12 months (no relapse) (evaluated only in patients with marked improvement at month 6) [ Time Frame: Day 365 +/- 15 days ]
    No reappearance or re-growth of the parasitic lesions on contrast enhanced MRI at 12 months after therapy onset, recorded as a dichotomous outcome. hypertension, or progressive neurologic deficits (in cognitive functions, motor function, gait, or other defined neurological signs) in a patient off steroid therapy, as assessed by a study neurologist 12 months post treatment.
  • Clinically asymptomatic patient [ Time Frame: 3, 6, and 12 months ]
    No evidence of uncontrolled seizures, chronic severe headaches, intracranial hypertension, or progressive neurologic deficits (in cognitive functions, motor function, gait, or other defined neurological signs) in a patient off steroid therapy, as assessed by a study neurologist at 3, 6, and 12 months post treatment.
  • Decrease in serum levels [ Time Frame: 3 months ]
    will be measured at 3 months, and expressed as a proportion of the baseline level. This variable will be compared between arms


Original Secondary Outcome: Same as current

Information By: Universidad Peruana Cayetano Heredia

Dates:
Date Received: October 24, 2016
Date Started: November 2016
Date Completion: November 2021
Last Updated: October 25, 2016
Last Verified: October 2016