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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00001645
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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
Malaria Intestinal Worms GI Protozoa Echiniococcus Strongyloides

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation, Treatment, and Monitoring of Patients With Known or Suspected Parasitic Infection
Actual Study Start Date : October 10, 1998

Resource links provided by the National Library of Medicine


Group/Cohort
Diarrhea GI Parasite
Subjects infected with a GI parasite
Echinococcus
Subjects infected with echinococcus
Intestinal Worm
Subjects infected with parasitic intestinal worm
Malaria
Subjects infected with malaria
Parasitic Infection
Subjects infected with a parasitic infection that is not included in the other cohorts



Primary Outcome Measures :
  1. The Laboratory of Parasitic Diseases has been conducting studies of the diagnosis, treatment, and pathogenesis of wide variety of parasitic infections. [ Time Frame: 1 year ]
    Elimination of parasitic infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary clinical
Criteria
  • INCLUSION CRITERIA:

Age 3 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 3 years of age.

No evidence suggestive of a parasitic infection.

Although pregnant or nursing women can be enrolled, they will be

excluded from receiving treatment while pregnant or breastfeeding


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001645


Contacts
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Contact: Nicole C Holland-Thomas, R.N. (301) 402-5969 hollandnc@mail.nih.gov
Contact: Thomas B Nutman, M.D. (301) 496-5399 tnutman@mail.nih.gov

Locations
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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
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Principal Investigator: Thomas B Nutman, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001645    
Other Study ID Numbers: 970096
97-I-0096
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 22, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Helminth Infection
Parasite
Known Parasitic Infection
Suspected Parasitic Infection
Additional relevant MeSH terms:
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Infection
Parasitic Diseases