Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001230
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
1999-11-03
Brief Title:
Host Response to Infection and Treatment in Filarial Diseases
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Host Response to Infection and Treatment in the Filarial Diseases of Humans
Status:
RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 13-inch in diameter and 12-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
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 13-inch in diameter and 12-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
Detailed Description:
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 88-I-0083 | None | None | None |