SANCC: Clinical Trial Early Intervention

NCT ID: NCT03950037

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-04-30

Brief Summary

Subarachnoid neurocysticercosis (SANCC) is a severe infection of the brain by the tapeworm Taenia solium. People who have this infection are usually diagnosed late in the disease process leading to very poor prognosis. This trial studies the safety of early medical intervention in people who have SANCC but do not have symptoms. The trial will enroll 18 participants in Peru.

Detailed Description

PRIMARY OBJECTIVE:

I. To estimate the risk of serious adverse events (SAE) related to intervention in asymptomatic SANCC; these include drug-related side effects, moderate/severe intracranial hypertension, hydrocephalus requiring shunting or endoscopy, stroke, status epilepticus, or unexplained death.

OUTLINE:

Participants will be hospitalized for approximately 15-30 days while they receive treatment with the antiparasitic drug albendazole, as well as additional drugs (dexmathesaone and omeprazole) to address potential treatment complications. Participants will have continuous monitoring for adverse events while in the hospital. After participants are released to home, they will monitored for adverse events for an additional 12 months through home visits, telephone contact, and monthly clinical evaluations with serologic and radiologic assessment.

Conditions

Subarachnoid Neurocysticercosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medical intervention

Participants are hospitalized for 15-30 days while they receive the antiparasitic drug albendazole along with supportive drugs including dexamethasone and omeprazole.

Group Type: EXPERIMENTAL

Albendazole

Intervention Type: DRUG

Albendazole; 15 mg/k/d divided in two doses (morning and evening), for 30 days, with a ceiling in 1200 mg/d.

Interventions

Albendazole

Albendazole; 15 mg/k/d divided in two doses (morning and evening), for 30 days, with a ceiling in 1200 mg/d.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female individuals older than two years with a diagnosis of asymptomatic SANCC confirmed by MRI.
• SANCC limited to the basal cisterns, the interhemispheric brain space, brain fissures or spine.
• Baseline laboratory results within acceptable ranges (specifically defined in the study protocol)
• Willingness to accomplish the two-week minimum hospitalization required.

Exclusion Criteria

• Individuals who only have subarachnoid lesions in the convexity of the brain hemispheres will not be included because these lesions commonly respond well to therapy and behave as intraparenchymal lesions
• Co-occurrence of a) more than 20 intraparenchymal lesions in addition to their subarachnoid disease, or b) intraparenchymal lesions greater than 3.0 cm of diameter
• Individuals for whom a surgical intervention to treat their subarachnoid disease is considered clearly superior to a medical intervention
• Previously diagnosis or treatment for cysticercosis.
• Active pulmonary tuberculosis evidenced by chest X-ray and positive sputum smears, or symptoms compatible with tuberculosis (fever+sweats or fever+cough) not otherwise explained
• Individuals with positive markers for active hepatitis
• Other systemic disease that may affect therapy or short-term prognosis, including but not limited to chronic renal failure, hepatic insufficiency, cardiac failure, or steroid-dependent immune diseases
• Pregnancy. If a participant becomes pregnant during the study, she will continue in the study but will have radiological exams delayed until after delivery
• History of hypersensitivity to ABZ
• Chronic alcohol or drug abuse as defined in the study protocol
• Unwilling or unable to provide MRI exams (e.g. patients with ferromagnetic implants)
• Inability or unwillingness of subject or legal representative to give written informed consent.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Seth E O'Neal, MD MPH

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seth E O'Neal, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Hector H Garcia, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Peruana Cayetano Heredia

Other Identifiers

1R01NS103623-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00019627

Identifier Type: -

Identifier Source: org_study_id