Protocol Number: 88-I-0083

Title:

Host Response to Infection and Treatment in the Filarial Diseases of Humans

Number:

88-I-0083

Summary:

This study will evaluate and treat patients with filarial infections to explore in depth the immunology of the disease, including susceptibility to infection, disease development, and response to treatment. Filarial infections are caused by parasitic worms. The immature worm (larva) is transmitted to a person through a mosquito bite and grows in the human body to 2 to 4 inches in length. Although many of these infections do not produce symptoms, especially in the early stages of infection, others can have serious consequences, including swelling of the limbs or genitalia, allergic-lung problems, skin rash, eye inflammation that can lead to blindness, and heart disease. This protocol does not involve any experimental diagnostic procedures or treatments, and will use only procedures employed in the standard practice of medicine.

Persons between 1 and 75 years of age diagnosed with or suspected of infection with Wuchereria bancrofti, Bugia malayi, Onchocerca volvulus, Loa loa, or other parasitic worms may be eligible for this study.

Participants will have routine tests to determine the specific type of filarial infection. These may include special tests of the lungs, skin or heart, depending on the type of parasite suspected. Patients with skin reactions may have a "punch biopsy" to examine a small piece of affected skin. For this procedure, an area of skin is numbed with an anesthetic and a small circular area, about 1/3-inch in diameter and 1/2-inch thick, is removed using a sharp cookie cutter-type instrument. Some patients may require bronchoalveolar lavage. For this procedure, the mouth and throat are numbed with lidocaine jelly and spray and, if needed, a sedative is given for comfort. A small plastic tube is placed in a vein to give medications. A pencil-thin tube is then passed through the nose or mouth into the lung airways to examine the airways. Salt water is injected through the bronchoscope into the air passage, acting as a rinse. A sample of the fluid is then withdrawn and examined for infection, inflammatory cells and inflammatory chemicals. (Bronchoalveolar lavage is done only if medically necessary and only on patients 21 years or older.) Once the diagnosis is established, standard treatment will be instituted with either diethylcarbamazine or ivermectin, depending on the type of infection.

Additional procedures for research purposes include:

- Extra blood draws to study immune cells and other immune substances. (This is the only research procedure that will be done in - More frequent and extensive follow-up evaluations than usual for routine care. They will include physical examination and blood studies.

- Urine collections at specified periods, possibly including 24-hour collections.

- Skin tests to examine the body's reaction to allergens-common environmental substances, such as cat dander or pollen-that cause an allergic reaction. The test is done in one of two ways: either the skin is lightly scratched and an allergen extract is placed over the just-broken skin, or a very fine needle is used to inject a small amount of allergen under the skin. In both methods, the site is monitored for swelling or hives in the next 48 hours.

- Leukapheresis (only on patients 21 or older ) to collect quantities of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body, either through the same needle or through another needle in the other arm.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

All patients 1-75 years of age suspected or proven to have filarial infection could be evaluated under this protocol.

For bronchoalveolar lavage, only those patients 21 years old or older with acceptable pulmonary function parameters, negative sputum culture and skin test for TB and no history of allergy to valium, atropine, or local anesthetic will be eligible. Furthermore, these individuals must have no other significant medical problems such as cardiac disease or coagulopathy.

Therapeutic plasmapheresis or leukapheresis will be performed on individuals 7 years of age or older and who weigh greater than 55kgs with the objective of decreasing their filarial burden prior to treatment. Research plasmapheresis or leukapheresis will be performed on individuals 18 years of age or older and who weigh greater than 55 kgs.

Donor requirements will be similar to those for whole blood donation, with screening done by both the investigator and the blood bank.

There should be no clinical contraindications to the procedure (for example, severe anemia, cardiovascular disease, coagulopathy, etc.).

The patient must understand fully the contents of the consent form.

Special Instructions: Currently Not Provided

Keywords:

Wuchereria Bancrofti

Loa Loa

Brugia Malayi

Brugia Timori

Onchocerca Volvulus

Mansonella Perstans

Mansonella Ozzardi

Diethylcarbamazine (DEC)

Suramin

Ivermectin

Recruitment Keywords:

Filarial Infection

Conditions:

Filariasis

Helminthiasis

Loiasis

Mansonelliasis

Onchocerciasis

Investigational Drug(s):

Diethylcarbamazine

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

T cell subpopulation phenotypes in filarial infections: identification of possible markers for Th2 cells

Polymerase chain reaction based diagnosis of Onchcerca volvulus infection: improved detection of patients with onchocerciasis

Effectiveness of diethylcarbamazine in treating loiasis acquired by expatriate visitors to endemic regions: long term followup

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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