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

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ClinicalTrials.gov Identifier: NCT00001645
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : April 2, 2018
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
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 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

Resource links provided by the National Library of Medicine





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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
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.


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
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)

Additional Information:
Publications:
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    Key Record Dates
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