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Study of Patients With Strongyloides Stercoralis Infection

This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), June 2008

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001245
  Purpose

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.

Condition
HIV Infection
Nematode Infection
Strongyloidiasis

MedlinePlus related topics:   AIDS    Allergy   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Study of Patients With Known or Suspected Infection With Strongyloides Stercoralis

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   650
Study Start Date:   August 1989

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.

  Eligibility
Ages Eligible for Study:   8 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001245

Contacts
Contact: Patient Recruitment and Public Liaison Office     (800) 411-1222     prpl@mail.cc.nih.gov    
Contact: TTY     1-866-411-1010    

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike     Recruiting
      Bethesda, Maryland, United States, 20892
Brazil
Federal University of Bahia     Recruiting
      Bahia, Brazil

Sponsors and Collaborators
  More Information


NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   890174, 89-I-0174
First Received:   November 3, 1999
Last Updated:   August 16, 2008
ClinicalTrials.gov Identifier:   NCT00001245
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Strongyloidiasis  
Immediate Hypersensitivity Skin Test  
IgE  
Nematode  
Immunosuppression  
Skin Test
Diagnosis
Intestinal Helminth
Immediate Hypersensitivity

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Anguillulosis
Acquired Immunodeficiency Syndrome
Nematode Infections
Immunologic Deficiency Syndromes
Virus Diseases
Strongyloidiasis
Hypersensitivity
HIV Infections
Sexually Transmitted Diseases
Hypersensitivity, Immediate
Parasitic Diseases
Helminthiasis
Retroviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
Rhabditida Infections
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection
Secernentea Infections

ClinicalTrials.gov processed this record on October 31, 2008




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