Sub Arachnoid Neurocysticercosis Treatment Outcome (SANTO)
Stopped: Albendazole and albendazole placebo are not available in our local suppliers or in the international market. Consequently, it is no possible to re-initiate the enrollment to complete the original sample size.
Peru107 participantsStarted 2016-11-14
Plain-language 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.
Who can participate
Age range18 Years ā 65 Years
SexALL
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Inclusion Criteria:
* \- Male or female adult individuals (18 to 65 y.o.) with a diagnosis of basal subarachnoid cysticercosis (including locations in the Sylvian fissure or lower interhemispheric spaces) by neuroimaging and confirmed by serology.
* Baseline laboratory results along acceptable ranges (specifically defined in the study protocol).
* Willingness to accomplish the two-week minimum hospitalization required.
Exclusion Criteria:
* Previous therapy with ABZ or PZQ in the preceding 3 years (except for patients who received single-dose ABZ for intestinal parasites, or patients who received antiparasitic treatment between one and three years before enrollment but demonstrated lesion persistence or progression during the past 12 months).
* A type of NCC which can expose the patient to increased risk during the study, specifically: a) intraventricular cysts; b) cysts in brainstem; c) concomitant intraparenchymal lesions greater than 3 cm of diameter in addition to their SANCC lesions; d) more than 20 intraparenchymal cysts in addition to their SANCC lesions; or d) untreated ocular cysticercosis. Patients with a lateral ventricle cyst, less than 2 cm in diameter, without hydrocephalus or intracranial hypertension, can be included. The presence of concomitant intraparenchymal cysts of less than 3 cm in diameter will not exclude the patient unless there are more than 20 of them.
* Active pulmonary tuberculosis evidenced by positive chest X-ray and positive sputum smears, ā¦
What they're measuring
1
Radiological efficacy at three months (3-month improvement).