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CompletedNCT00001245Updated Aug 25, 2009

Study of Patients With Strongyloides Stercoralis Infection

An observational study in HIV Infection, Nematode Infection and Strongyloidiasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 8 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-08-25.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Study type
Observational
Enrollment
650
Ages
8 Years to 80 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • HIV Infection
  • Nematode Infection
  • Strongyloidiasis

Keywords

  • Strongyloidiasis
  • Immediate Hypersensitivity Skin Test
  • IgE
  • Nematode
  • Immunosuppression
  • Skin Test
  • Diagnosis
  • Intestinal Helminth
  • Immediate Hypersensitivity
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 650 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

EXCLUSION CRITERIA:

Less than 5 years of age

Pregnancy is not a criterion for exclusion.

05

Study design

Enrollment
650 participants
06

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
07

References and documents

Publications

  • Neva FA. Biology and immunology of human strongyloidiasis. J Infect Dis. 1986 Mar;153(3):397-406. doi: 10.1093/infdis/153.3.397. PubMed 3081656 ↗
  • 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. PubMed 1543206 ↗
  • 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. PubMed 3699981 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00001245
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
First posted
Nov 4, 1999
Start date
Aug 1989
Primary completion
May 2009
Last update
Aug 25, 2009
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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