Treatment of Patients With Cysticercosis With Praziquantel or Albendazole

Conditions Phase Intervention Type

Eligibility

Ages Eligible for Study
24 months to 75 years
Genders Eligible for Study
Both

Keywords

Taenia Solium, Cysticercosis, and Praziquantel

Sponsors

NIH
National Institute of Allergy and Infectious Diseases (NIAID)

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 NCC. The diagnosis of NCC depends on the presence
of cysts by MRI or computed tomography (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 purified protein derivative or quantiferon assay for
tuberculosis (TB) and strongyloidiasis will be started/treated for these
infections, per standard protocol, and shortly thereafter treated for NCC.

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 NCC is life
threatening.

Detailed Description

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001205

Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland United States

    Status: Recruiting

    Contact info For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
    800-411-1222xTTY8664111010

Overall Contact

Theodore E Nash, M.D.
(301) 496-6920

Overall Contact Backup

Nicole C Holland-Thomas, R.N.
(301) 402-5969