Treatment of Patients With Cysticercosis With Praziquantel or Albendazole
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 2 - 75 |
| Updated: | 1/17/2019 |
| Start Date: | July 22, 1985 |
| Contact: | Nicole C Holland-Thomas, R.N. |
| Email: | hollandnc@mail.nih.gov |
| Phone: | (301) 402-5969 |
Treatment of Cysticercosis Including Neurocysticercosis With Praziquantel, Albendazole and Other Novel Treatment Modalities
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.
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.
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
[NCC]) 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 Food and Drug
Administration 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.
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
[NCC]) 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 Food and Drug
Administration 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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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