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临床试验/NCT00001230
NCT00001230招募中不适用

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

National Institute of Allergy and Infectious Diseases (NIAID)1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 1991年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Define the determinants of the susceptibility to filarial infection, the development of filarial disease and the beneficial or adverse response to chemotherapy

研究概览

简要总结

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 3 and 100 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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • INCLUSION CRITERIA:
  • Age 3-100 years.
  • Access to a primary medical care provider outside of the NIH.
  • Ability to give informed consent.
  • Clinical evidence suggestive of a filarial infection

排除标准

  • Although pregnant or nursing women can be enrolled, they will be excluded from receiving treatment while pregnant or breastfeeding
  • Less than 3 year of age; greater than 100 years of age
  • Any condition that the investigator feels put the subject at unacceptable risk for participation in the study

研究组 & 干预措施

1

Patients that have, or are suspected of having, one of the filarial infections affecting humans

干预措施: Diethylcarbamazine (Drug)

结局指标

主要结局

Define the determinants of the susceptibility to filarial infection, the development of filarial disease and the beneficial or adverse response to chemotherapy

时间窗: 10 years

Susceptibilities to filarial infection will be determined

次要结局

  • To understand the natural history of filarial infections in expatriates and other travelers and in immigrant populations(10 years)
  • To identify clinical and biological markers of successful treatment in filarial-infected individuals(10 years)
  • To characterize the immunoregulatory mechanisms at play in filaria-infected individuals(10 years)
  • To create a serum and cell bank for the study of filarial infections of humans both before and at fixed times following definitive treatment.(10 years)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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