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Treatment of Patients With Cysticercosis With Praziquantel or Albendazole

This study is currently recruiting participants.
Verified October 11, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001205
First Posted: November 4, 1999
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
  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.


Condition
Cysticercosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Cysticercosis Including Neurocysticercosis With Praziquantel, Albendazole and Other Novel Treatment Modalities

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: July 22, 1985
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001205


Contacts
Contact: Nicole C Holland-Thomas, R.N. (301) 402-5969 hollandnc@mail.nih.gov
Contact: Theodore E Nash, M.D. (301) 496-6920 tnash@niaid.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Theodore E Nash, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001205     History of Changes
Other Study ID Numbers: 850127
85-I-0127
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: October 27, 2017
Last Verified: October 11, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Taenia Solium
Cysticercosis
Praziquantel

Additional relevant MeSH terms:
Parasitic Diseases
Central Nervous System Parasitic Infections
Cysticercosis
Taeniasis
Neurocysticercosis
Cestode Infections
Helminthiasis
Central Nervous System Helminthiasis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Albendazole
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents