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Study of Patients With Strongyloides Stercoralis Infection

Primary Purpose

HIV Infection, Nematode Infection, Strongyloidiasis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infection focused on measuring Strongyloidiasis, Immediate Hypersensitivity Skin Test, IgE, Nematode, Immunosuppression, Skin Test, Diagnosis, Intestinal Helminth, Immediate Hypersensitivity

Eligibility Criteria

8 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: Age of 5 to 80 years and of either sex. Access to primary medical care provider outside of the NIH Ability to give written informed consent (for adults) and parental consent (for those under 18) Presence of known or suspected infection with Stronglyloides stercoralis, such as significant peripheral blood eosinophilia (greater than 1000 eosinophils/mm(3)) for which no other cause is apparent. Willingness to participate and provide blood for in vitro assays and serum storage. EXCLUSION CRITERIA: Less than 5 years of age Pregnancy is not a criterion for exclusion.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
August 24, 2009
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001245
Brief Title
Study of Patients With Strongyloides Stercoralis Infection
Official Title
Study of Patients With Known or Suspected Infection With Strongyloides Stercoralis
Study Type
Observational

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
August 1989 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Nematode Infection, Strongyloidiasis
Keywords
Strongyloidiasis, Immediate Hypersensitivity Skin Test, IgE, Nematode, Immunosuppression, Skin Test, Diagnosis, Intestinal Helminth, Immediate Hypersensitivity

7. Study Design

Enrollment
650 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Age of 5 to 80 years and of either sex. Access to primary medical care provider outside of the NIH Ability to give written informed consent (for adults) and parental consent (for those under 18) Presence of known or suspected infection with Stronglyloides stercoralis, such as significant peripheral blood eosinophilia (greater than 1000 eosinophils/mm(3)) for which no other cause is apparent. Willingness to participate and provide blood for in vitro assays and serum storage. EXCLUSION CRITERIA: Less than 5 years of age Pregnancy is not a criterion for exclusion.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3081656
Citation
Neva FA. Biology and immunology of human strongyloidiasis. J Infect Dis. 1986 Mar;153(3):397-406. doi: 10.1093/infdis/153.3.397.
Results Reference
background
PubMed Identifier
1543206
Citation
Newton RC, Limpuangthip P, Greenberg S, Gam A, Neva FA. Strongyloides stercoralis hyperinfection in a carrier of HTLV-I virus with evidence of selective immunosuppression. Am J Med. 1992 Feb;92(2):202-8. doi: 10.1016/0002-9343(92)90113-p.
Results Reference
background
PubMed Identifier
3699981
Citation
Sato Y, Otsuru M, Takara M, Shiroma Y. Intradermal reactions in strongyloidiasis. Int J Parasitol. 1986 Feb;16(1):87-91. doi: 10.1016/0020-7519(86)90070-6. No abstract available.
Results Reference
background
Links:
URL
http://clinicalstudies.info.nih.gov/detail/B_1989-I-0174.html
Description
NIH Clinical Center Detailed Web Page

Learn more about this trial

Study of Patients With Strongyloides Stercoralis Infection

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