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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease
Parasitic Disease

Detailed 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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	500 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Evaluation, Treatment, and Monitoring of Patients With Known or Suspected Parasitic Infection
Study Start Date :	March 24, 1997

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. To evaluate, treat and follow patients with parasitic infections not covered by existing LPD/NIAID protocols [ Time Frame: Continuous ]
2. To screen patients with suspected parasitic infections for enrollment on other LPD/NIAID protocols [ Time Frame: Continuous ]

Eligibility Criteria

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Ages Eligible for Study:	1 Year and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

• INCLUSION CRITERIA:

Age 1 or over.

Access to a primary medical care provider outside of the NIH.

Ability to give written informed consent (for adults) and parental consent (for those under 18).

Clinical evidence suggestive of a parasitic infection.

EXCLUSION CRITERIA:

Less than 1 year of age.

No evidence suggestive of a parasitic infection.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Thomas W Brown, R.N.	(301) 402-7823	thomas.brown2@nih.gov
Contact: Thomas B Nutman, M.D.	(301) 496-5399	tnutman@mail.nih.gov

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:	Thomas B Nutman, M.D.	National Institute of Allergy and Infectious Diseases (NIAID)

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

Publications:

Mitre E, Nutman TB. Basophils, basophilia and helminth infections. Chem Immunol Allergy. 2006;90:141-56. Review.

Klion AD, Nutman TB. Infectious diseases of international travel. Adv Intern Med. 2001;47:265-92. Review.

Kim YJ, Nutman TB. Eosinophilia: causes and pathobiology in persons with prior exposures in tropical areas with an emphasis on parasitic infections. Curr Infect Dis Rep. 2006 Jan;8(1):43-50.

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00001645 History of Changes
Other Study ID Numbers:	970096; 97-I-0096
First Posted:	November 4, 1999
Last Update Posted:	April 2, 2018
Last Verified:	August 9, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):

Chagas' Disease; Trypanosomiasis; Malaria; Parasitic Infection

Additional relevant MeSH terms:

Infection; Parasitic Diseases