Clinical Trial: Treatment of Patients With Cysticercosis With Praziquantel or Albendazole

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Treatment of Cysticercosis Including Neurocysticercosis With Praziquantel, Albendazole and Other Novel Treatment Modalities

Brief Summary:

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 ma

    Detailed Summary: The purpose of this protocol is to allow evaluation, treatment and follow up of patients with cysticercosis. Cysticercosis is defined as an infection with the larvae 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 has recently been approved for the treatment of cysticercosis while praziquantel is not approved by the FDA but has proven efficacy and safety. To decrease the provoked inflammation which can be induced by treatment or to decrease inflammation in active disease, corticosteroids or other immunosuppressive will be used. Anti seizure medications are also commonly used.
    Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

    Current Primary Outcome:

    • To study the clinical course of cysticercosis following therapy [ Time Frame: indefinite ]
    • To diminish morbidity associated with treatment of cysticercosis including neurocysticercosis or the inflammation associated with therapy [ Time Frame: indefinite ]


    Original Primary Outcome:

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: November 3, 1999
    Date Started: July 22, 1985
    Date Completion:
    Last Updated: April 21, 2017
    Last Verified: November 17, 2016