NCT00001245

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1989

Completed
10.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Last Updated

August 25, 2009

Status Verified

May 1, 2009

Enrollment Period

19.8 years

First QC Date

November 3, 1999

Last Update Submit

August 24, 2009

Conditions

Keywords

StrongyloidiasisImmediate Hypersensitivity Skin TestIgENematodeImmunosuppressionSkin TestDiagnosisIntestinal HelminthImmediate Hypersensitivity

Eligibility Criteria

Age8 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Less than 5 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

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

    PMID: 3081656BACKGROUND
  • 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.

    PMID: 1543206BACKGROUND
  • 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.

    PMID: 3699981BACKGROUND

Related Links

MeSH Terms

Conditions

HIV InfectionsNematode InfectionsStrongyloidiasisEnterobiasisDiseaseHypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHelminthiasisParasitic DiseasesRhabditida InfectionsSecernentea InfectionsOxyuriasisOxyurida InfectionsPathologic ProcessesPathological Conditions, Signs and SymptomsHypersensitivity

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

August 1, 1989

Primary Completion

May 1, 2009

Last Updated

August 25, 2009

Record last verified: 2009-05

Locations