Evaluation, Treatment and Monitoring of Patients With a Known or Suspected Parasitic Infection

Malaria Clinical Trial

Official title:

Evaluation, Treatment, and Monitoring of Patients With Known or Suspected Parasitic Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00001645
• Other study ID #: 970096
• Secondary ID: 97-I-0096
• Status: Recruiting
• Start date: October 10, 1998

Study information

• Verified date: February 12, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Thomas B Nutman, M.D.
• Phone: (301) 496-5399
• Email: tnutman[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate, treat and follow patients with parasitic infections.

People with a known or suspected parasitic infection who are at least 1 year old may be enrolled. This study does not involve any experimental treatments.

Participants will have a physical examination and laboratory tests on blood, stool, or urine. Blood samples may be collected at regular intervals, but no more than 450 ml (15 ounces) of blood will be drawn from adults, and no more than 7 ml (1-1/2 teaspoons) per kg (2.2 pounds) of body weight from children, in any 6-week period. Other tests may include x-rays, electrocardiogram (EKG), or tissue biopsy (surgical removal of a small tissue sample), depending on the individual s condition.

Patients may be offered treatment or may be referred to another study that is more appropriate for the problem. Any treatment provided in this study will be according to standard medical practice for the patient s specific medical problem. Patients responses to treatment will be evaluated at regularly scheduled clinic visits. The length of time between visits and the total duration of the study for a given individual will be determined by the study doctor, based on that person s medical condition.

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Description:

This study is designed as a prospective study to evaluate and treat patients with parasitic infection. Patients with known or suspected parasitic infection will be enrolled and will be evaluated for the presence of a parasitic infection. Minimal studies scheduled for each visit will include a medical history, physical examination, routine laboratory tests, and specialized diagnostic procedures for possible parasitic infections. Treatment plans will be individualized for each patient's particular condition, and the number and length of additional visits and diagnostic evaluations will vary accordingly. Specific treatment regimens will be in accordance with standard medical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

• INCLUSION CRITERIA:

Age 3 or over.

Access to a primary medical care provider outside of the NIH

Clinical evidence suggestive of a parasitic infection

EXCLUSION CRITERIA:

Less than 3 years of age

No evidence suggestive of a parasitic infection

Related Conditions & MeSH terms

• Echiniococcus
• GI Protozoa
• Infections
• Intestinal Worms
• Malaria
• Parasitic Diseases
• Strongyloides

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Nash TE, Ohl CA, Thomas E, Subramanian G, Keiser P, Moore TA. Treatment of patients with refractory giardiasis. Clin Infect Dis. 2001 Jul 1;33(1):22-8. doi: 10.1086/320886. Epub 2001 May 23. — View Citation

Nutman TB. Human infection with Strongyloides stercoralis and other related Strongyloides species. Parasitology. 2017 Mar;144(3):263-273. doi: 10.1017/S0031182016000834. Epub 2016 May 16. — View Citation

O'Connell EM, Nutman TB. Eosinophilia in Infectious Diseases. Immunol Allergy Clin North Am. 2015 Aug;35(3):493-522. doi: 10.1016/j.iac.2015.05.003. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Laboratory of Parasitic Diseases has been conducting studies of the diagnosis, treatment, and pathogenesis of wide variety of parasitic infections.	Elimination of parasitic infection.	1 year

External Links

•   NIH Clinical Center Detailed Web Page