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出境医 / 临床实验 / SANCC: Clinical Trial Early Intervention

SANCC: Clinical Trial Early Intervention

Study Description
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.

Condition or disease Intervention/treatment Phase
Subarachnoid Neurocysticercosis Drug: Albendazole Phase 2

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Non-randomized Phase IIa Trial to Evaluate Safety of Early Intervention in Asymptomatic Subarachnoid Neurocysticercosis
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Medical intervention
Participants are hospitalized for 15-30 days while they receive the antiparasitic drug albendazole along with supportive drugs including dexamethasone and omeprazole.
 Drug: Albendazole
Albendazole; 15 mg/k/d divided in two doses (morning and evening), for 30 days, with a ceiling in 1200 mg/d.
Outcome Measures
Primary Outcome Measures :
  1. Safety; severe adverse events [ Time Frame: The 3 month period directly following the intervention ]
    Proportion of subjects that experience any severe adverse event that is directly related to the treatment intervention


Secondary Outcome Measures :
  1. Safety; all adverse events [ Time Frame: The 12 month period directly following the intervention ]
    Frequency and type of all adverse events

  2. Diagnostic; antigen levels [ Time Frame: Months 3,6,9, and 12 after intervention ]
    Correlation between urine and serum levels of circulating parasite antigen and lesion resolution on MRI as a potential marker of treatment effect


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Seth E O'Neal, MD MPH (504)494-0300 oneals@ohsu.edu
Contact: Hector H Garcia, MD PhD 511 328-7360 hgarcia@jhsph.edu

Sponsors and Collaborators
Oregon Health and Science University
Universidad Peruana Cayetano Heredia
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Layout table for investigator information
Principal Investigator: Seth E O'Neal, MD MPH Oregon Health and Science University
Principal Investigator: Hector H Garcia, MD PhD Universidad Peruana Cayetano Heredia
Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date May 4, 2021
Estimated Study Start Date  ICMJE January 1, 2022
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019) 		Safety; severe adverse events [ Time Frame: The 3 month period directly following the intervention ]
Proportion of subjects that experience any severe adverse event that is directly related to the treatment intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Safety; all adverse events [ Time Frame: The 12 month period directly following the intervention ]
    Frequency and type of all adverse events
  • Diagnostic; antigen levels [ Time Frame: Months 3,6,9, and 12 after intervention ]
    Correlation between urine and serum levels of circulating parasite antigen and lesion resolution on MRI as a potential marker of treatment effect
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SANCC: Clinical Trial Early Intervention
Official Title  ICMJE An Open-label Non-randomized Phase IIa Trial to Evaluate Safety of Early Intervention in Asymptomatic Subarachnoid Neurocysticercosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Subarachnoid Neurocysticercosis
Intervention  ICMJE Drug: Albendazole
Albendazole; 15 mg/k/d divided in two doses (morning and evening), for 30 days, with a ceiling in 1200 mg/d.
Study Arms  ICMJE Experimental: Medical intervention
Participants are hospitalized for 15-30 days while they receive the antiparasitic drug albendazole along with supportive drugs including dexamethasone and omeprazole.
Intervention: Drug: Albendazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2019) 		18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seth E O'Neal, MD MPH (504)494-0300 oneals@ohsu.edu
Contact: Hector H Garcia, MD PhD 511 328-7360 hgarcia@jhsph.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03950037
Other Study ID Numbers  ICMJE 00019627
1R01NS103623-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized patient data for primary and secondary outcomes will be made available.
Time Frame: 6 months after trial completion
Access Criteria: Data access requests will be reviewed by the principal investigators. Requestors will be required to sign a Data Use Agreement.
Responsible Party Seth E O'Neal, MD MPH, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE
  • Universidad Peruana Cayetano Heredia
  • National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Seth E O'Neal, MD MPH Oregon Health and Science University
Principal Investigator: Hector H Garcia, MD PhD Universidad Peruana Cayetano Heredia
PRS Account Oregon Health and Science University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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