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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT00001645
First received: November 3, 1999
Last updated: October 4, 2014
Last verified: September 2014
  Purpose

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
Parasitic Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation, Treatment, and Monitoring of Patients With Known or Suspected Parasitic Infection

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To evaluate, treat and follow patients with parasitic infections not covered by existing LPD/NIAID protocols [ Time Frame: Continuous ] [ Designated as safety issue: No ]
  • To screen patients with suspected parasitic infections for enrollment on other LPD/NIAID protocols [ Time Frame: Continuous ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 1997
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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001645

Contacts
Contact: Tamika S Magee, R.N. (301) 443-5458 mageets@mail.nih.gov
Contact: Thomas B Nutman, M.D. (301) 496-5398 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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas B Nutman, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT00001645     History of Changes
Other Study ID Numbers: 970096, 97-I-0096
Study First Received: November 3, 1999
Last Updated: October 4, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Chagas' Disease
Trypanosomiasis
Malaria
Parasitic Infection

Additional relevant MeSH terms:
Infection
Parasitic Diseases

ClinicalTrials.gov processed this record on November 20, 2014