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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001230 |
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 A sample of the fluid is then withdrawn and examined for infection, inflammatory cells and inflammatory chemicals.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:
Condition |
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Filariasis Helminthiasis Loiasis Mansonelliasis Onchocerciasis |
Study Type: | Observational |
Official Title: | Host Response to Infection and Treatment in the Filarial Diseases of Humans |
Estimated Enrollment: | 500 |
Study Start Date: | May 1988 |
Patients admitted on this protocol will have, or be suspected of having, one of the filarial infections affecting humans. After routine clinical evaluation they will be studied in depth immunologically, and their blood cells and/or serum will be collected to provide reagents (eg., specific antibodies, T-cell clones, etc.) that will be used in the laboratory to address the broader questions of diagnosis, immunoregulation, pathology and immunoprophylaxis. Careful observations of the patients' clinical and immunologic responses to therapy will be made, as well as long-term follow-up of these changes. It is anticipated both that the patients will receive optimal clinical care for their infections and that the specimens collected from them will prove to be valuable reagents for the laboratory studies of the immunologic responses unique to filarial or other related helminth infections.
Ages Eligible for Study: | 1 Year to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Age 1-75 years.
Access to a primary medical care provider outside of the NIH.
Ability to give informed consent.
Therapeutic plasmapheresis or leukapheresis:
Research plasmapheresis or leukapheresis
EXCLUSION CRITERIA:
Pregnant or nursing women will be excluded from the treatment arm of the study.
Less than 1 year of age; greater than 75 years of age.
For research pheresis:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 880083, 88-I-0083 |
Study First Received: | November 3, 1999 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00001230 |
Health Authority: | United States: Federal Government |
Wuchereria Bancrofti Loa Loa Brugia Malayi Brugia Timori Onchocerca Volvulus Mansonella Perstans |
Mansonella Ozzardi Diethylcarbamazine (DEC) Suramin Ivermectin Filarial Infection |
Diethylcarbamazine Skin Diseases Onchocerciasis Intestinal Volvulus Suramin Filariasis Dipetalonema Infections Loiasis |
Nematode Infections Skin Diseases, Infectious Mansonelliasis Ivermectin Parasitic Diseases Acanthocheilonemiasis Helminthiasis |
Spirurida Infections Skin Diseases, Parasitic Infection Secernentea Infections |