Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001245
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
1999-11-03
Brief Title:
Study of Patients With Strongyloides Stercoralis Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Study of Patients With Known or Suspected Infection With Strongyloides Stercoralis
Status:
COMPLETED
Status Verified Date:
2009-05
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 explore faster and easier ways to detect infection with the intestinal parasite Strongyloides stercoralis and learn more about the conditions under which it causes serious disease Ordinarily the Strongyloides helminth type of intestinal worm causes only few if any symptoms but in people with weakened immunity it may be very serious and even deadly
People between 5 and 80 years of age with known or suspected S stercoralis infection or infection with another helminth such as filariasis that might cause a cross-reaction with S stercoralis may be eligible for this study
Participants found to be infected with S stercoralis will be treated with ivermectin thiabendazole or albendazole In addition they will undergo the following tests and procedures
Blood tests and stool samples Samples will be collected before and after treatment to check general health status and immune function and to look for parasites in stool Up to 50 milliliters 10 teaspoons of blood will be drawn in adults and up to 25 ml 5 teaspoons in children
Skin tests A test similar to those used for tuberculosis and allergies will be conducted to determine if there is sensitization to products of the parasite Such a test might be used as a rapid method to diagnose the infection About three drops of several different antigens proteins are injected into the skin of the arm After 15 to 20 minutes the area is checked to see if a red spot has formed and if so the spot is measured
People between 5 and 80 years of age with known or suspected S stercoralis infection or infection with another helminth such as filariasis that might cause a cross-reaction with S stercoralis may be eligible for this study
Participants found to be infected with S stercoralis will be treated with ivermectin thiabendazole or albendazole In addition they will undergo the following tests and procedures
Blood tests and stool samples Samples will be collected before and after treatment to check general health status and immune function and to look for parasites in stool Up to 50 milliliters 10 teaspoons of blood will be drawn in adults and up to 25 ml 5 teaspoons in children
Skin tests A test similar to those used for tuberculosis and allergies will be conducted to determine if there is sensitization to products of the parasite Such a test might be used as a rapid method to diagnose the infection About three drops of several different antigens proteins are injected into the skin of the arm After 15 to 20 minutes the area is checked to see if a red spot has formed and if so the spot is measured
Detailed Description:
This study is directed to patients with known or suspected Strongyloides stercoralis infection because it is a relatively common parasitic infection even in the United States It is difficult to diagnose and efficacy of treatment is difficult to evaluate Some infected individuals can develop serious even fatal disease under certain conditions of immunosuppression Because newer diagnostic methods are needed to diagnose this infection we have developed new diagnostics that will be evaluated in comparison to more standard diagnostic tests Serum and cells will also be collected from patients on this protocol to understand the cellular and humoral response to the parasite and its antigens All subjects proven to have Strongyloides stercoralis infection will be treated with standard therapy and followed to assess both the efficacy of treatment and the changes in humoral and cellular immune responses induced by treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 89-I-0174 | None | None | None |