Protocol Details
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
This study is currently recruiting participants.
Summary
Number | 85-I-0127 |
Sponsoring Institute | National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail | Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 Years
Max Age: 99 Years |
Referral Letter Required | No |
Population Exclusion(s) | None |
Keywords | Tapeworm;
Taenia Solium;
Neurocysticercosis;
Natural History;
Seizures;
Aseptic Meningitis;
Hydrocephalus |
Recruitment Keyword(s) | None |
Condition(s) | Cysticercosis;
Neurocysticercosis |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Institute of Allergy and Infectious Diseases |
Neurocysticercosis is a brain disease due to the larval stage of the pork tapeworm (Taenia solium). The most common symptoms patient experience from infection inside the substance of the brain (parenchymal disease) are seizures and headaches. When the infection is either inside the fluid pockets inside the brain (ventricular disease) or in the space around the brain (subarachnoid disease) patients can have chronic headaches, relapsing aseptic meningitis, hydrocephalus, stroke, and may require neurosurgical intervention. The purpose of this study is to treat patients with anthelmintic therapy (praziquantel and/or albendazole) and anti-inflammatories in alignment with currently accepted best practices and guidelines, depending on the neurocysticercosis subtype. The purpose of the study is to better understand and characterize clinical, biologic, and management factors during treatment that influence long term outcomes. In order to understand this further we collect patient clinical information, patient survey responses, blood, urine samples, and additional cerebral spinal fluid if already being collected for clinical care.
Eligibility
INCLUSION CRITERIA:
Arms 1-5 (NCC):
1. Aged 3 years and older.
2. Ability of participant (or legally authorized representative, LAR) to understand and the willingness to sign a written informed consent document.
3. Patients with proven or likely NCC
Arm 6 (Endemic Exposures):
1. Patient with epidemiologic history compatible with possible exposure to NCC
2. Aged 18 years and older.
EXCLUSION CRITERIA:
Not applicable
Citations:
McAleese KR, Guzm(SqrRoot)(Degree)n JJ, Thumm L, Nutman TB, Showler A, O'Connell EM. Chagas Disease Prevalence in a Cohort of Neurocysticercosis Patients in a Nonendemic Setting. Clin Infect Dis. 2022 Sep 14;75(5):897-900. doi: 10.1093/cid/ciac076. PMID: 35134144; PMCID: PMC9477447. Beatty NL, Kaur H, Schlaffer K, Thompson K, Manavalan P, Rijos ZR, Raman AA, Droghini HR, O'Connell EM. Subarachnoid Neurocysticercosis Case Series Reveals a Significant Delay in Diagnosis-Requiring a High Index of Suspicion Among Those at Risk. Open Forum Infect Dis. 2024 Mar 21;11(5):ofae176. doi: 10.1093/ofid/ofae176. PMID: 38680612; PMCID: PMC11055394. Tang NL, Nash TE, Corda M, Nutman TB, O'Connell EM. Triplex ELISA for Assessing Durability of Taenia solium Seropositivity after Neurocysticercosis Cure. Emerg Infect Dis. 2023 Jul;29(7):1340-1348. doi: 10.3201/eid2907.230364. PMID: 37347506; PMCID: PMC10310364. Corda M, Sciurba J, Blaha J, Mahanty S, Paredes A, Garcia HH, Nash TE, Nutman TB, O'Connell EM. A recombinant monoclonal-based Taenia antigen assay that reflects disease activity in extra-parenchymal neurocysticercosis. PLoS Negl Trop Dis. 2022 May 26;16(5):e0010442. doi: 10.1371/journal.pntd.0010442. PMID: 35617367; PMCID: PMC9176767. Harrison S, Thumm L, Nash TE, Nutman TB, O'Connell EM. The Local Inflammatory Profile and Predictors of Treatment Success in Subarachnoid Neurocysticercosis. Clin Infect Dis. 2021 May 4;72(9):e326-e333. doi: 10.1093/cid/ciaa1128. PMID: 33269789; PMCID: PMC8096242. Nash TE, O'Connell EM. Subarachnoid neurocysticercosis: emerging concepts and treatment. Curr Opin Infect Dis. 2020 Oct;33(5):339-346. doi: 10.1097/QCO.0000000000000669. PMID: 32868512; PMCID: PMC7733161. Tang NL, Schaughency P, Gazzinelli-Guimaraes P, Lack J, Thumm L, Miltenberger E, Nash TE, Nutman TB, O'Connell EM. Immunologic Profiling of CSF in Subarachnoid Neurocysticercosis Reveals Specific Interleukin-10-Producing Cell Populations During Treatment. Neurol Neuroimmunol Neuroinflamm. 2024 Nov;11(6):e200320. doi: 10.1212/NXI.0000000000200320. Epub 2024 Oct 30. PMID: 39475624; PMCID: PMC11527482. Nash TE, O'Connell EM, Hammoud DA, Wetzler L, Ware JM, Mahanty S. Natural History of Treated Subarachnoid Neurocysticercosis. Am J Trop Med Hyg. 2020 Jan;102(1):78-89. doi: 10.4269/ajtmh.19-0436. PMID: 31642423; PMCID: PMC6947806. O'Connell EM, Harrison S, Dahlstrom E, Nash T, Nutman TB. A Novel, Highly Sensitive Quantitative Polymerase Chain Reaction Assay for the Diagnosis of Subarachnoid and Ventricular Neurocysticercosis and for Assessing Responses to Treatment. Clin Infect Dis. 2020 Apr 15;70(9):1875-1881. doi: 10.1093/cid/ciz541. PMID: 31232448; PMCID: PMC7156770.
Contacts:
Clinical Trials Number:
NCT00001205