Bethesda, Maryland 20892


Purpose:

The purpose of this study is to evaluate, treat and follow patients with cysticercosis, an infection with the larval form of the pork tapeworm, T. solium. When people ingest cysts of T. solium eggs, cysts develop in the muscles, brain and other organs. The cysts enlarge and cause inflammation, usually in the brain. Patients may develop seizures, headache, nausea, vomiting, inability to walk, poor vision due to enlargement of the brain, and increased pressure in the brain. Other neurological problems may develop depending on the location of the cysts. The drugs praziquantel and albendazole are used to treat cysticercosis, but it is not clear if these drugs are effective in all patients, such as those with calcified cysts or brain enlargement. Patients with suspected or confirmed cysticercosis may be eligible for this study. Participants will be hospitalized for 2 to 3 weeks and will take either praziquantel or albendazole by mouth for 2 weeks. They may receive a corticosteroid to lessen the side effects of the drug therapy. Patients will be evaluated with medically indicated tests and procedures that may include: - Blood tests. - X-rays of the head and long bones. - Electroencephalogram recording of the electrical activity of the brain - Lumbar puncture (spinal tap) examination of the cerebrospinal fluid that bathes the brain and spinal cord. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle. - Eye examination. - Magnetic resonance imaging (MRI) to examine the brain. MRI uses a strong magnetic field and radio waves instead of X-rays to demonstrate structural and chemical changes in the brain. During the scan, the patient lies on a table in a narrow cylinder (the scanner). He or she can speak with a staff member via an intercom system at all times during the procedure. - Computed tomography (CT) to examine the brain. CT can be done from different angles and allows the doctor to view the brain in small sections in 3-dimensions. The patient lies on a table with the head positioned in the CT scanner. Some of the tests may be repeated on the last day of therapy and at 3 and 6 months or longer after therapy.


Study summary:

The purpose of this protocol is to allow diagnosis, evaluation, treatment and follow up of patients with cysticercosis, while allowing for sample collection to improve diagnostic assays and explore host-parasite interactions. Cysticercosis is defined as an infection with the larval form of Taenia solium and includes infection of the brain (neurocysticercosis) that accounts for most of the symptomatic disease and serious complications. Evaluation and treatment follows accepted clinical practice and information learned is observational. Two drugs, praziquantel and albendazole, have been used extensively in the treatment of cysticercosis and are the accepted therapies. Albendazole is approved for the treatment of cysticercosis while praziquantel is not approved by the FDA but has proven efficacy and safety, and combined therapy is now standard of care to treat NCC. To decrease the treatment-provoked inflammation systemic corticosteroids and/or other immunosuppressive agents will be used. Anti-seizure medications are also commonly used.


Criteria:

- INCLUSION CRITERIA: 1. Patients ages 2 to 75 years will be considered for therapy. Children under age 18 will not normally be eligible for use of immunosuppressives other than corticosteroids. 2. Patients with proven or likely neurocysticercosis. The diagnosis of neurocysticercosis depends on the presence of cysts by MRI or CT scan and/or the presence of typical calcifications by CT. Serology is usually, but not always, positive and depends on the burden and type of disease. 3. Willing to sign consent and be seen at prescribed intervals 4. Patients who are pregnant will be included, however, they will not be offered treatment with albendazole, praziquantel and/or methotrexate and etanercept during the pregnancy unless the clinical condition is severe, e.g. life threatening, in the opinion of the PI. They may receive corticosteroids. 5. Patients with a positive PPD or quantiferon assay for TB and strongyloidiasis will be started/treated for these infections, per standard protocol, and shortly thereafter treated for neurocysticercosis. EXCLUSION CRITERIA: 1. < 2 years of age 2. Unwilling to undergo effective birth control measures if use of anthelmintics or immunosuppressives (other than corticosteroids) is required. 3. Breast-feeding if anthelmintics or immunosuppressive medications are required. 4. Allergic to albendazole and praziquantel 5. Active tuberculosis or strongyloides or other infections made worse with immunosuppression or other infections likely to be made worse unless neurocysticercosis is life threatening.


NCT ID:

NCT00001205


Primary Contact:

Principal Investigator
Theodore E Nash, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)

Tamika S Magee, R.N.
Phone: (301) 443-5458
Email: mageets@mail.nih.gov


Backup Contact:

Email: tnash@niaid.nih.gov
Theodore E Nash, M.D.
Phone: (301) 496-6920


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 22, 2017

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