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

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

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Thomas B Nutman, M.D.; Phone Number: (301) 496-5399; Email: tnutman@mail.nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY dial 711 800-411-1222; Email: ccopr@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary clinical.

Description

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Corda M, Sciurba J, Blaha J, Mahanty S, Paredes A, Garcia HH, Nash TE, Nutman TB, O'Connell EM. A recombinant monoclonal-based Taenia antigen assay that reflects disease activity in extra-parenchymal neurocysticercosis. PLoS Negl Trop Dis. 2022 May 26;16(5):e0010442. doi: 10.1371/journal.pntd.0010442. eCollection 2022 May.
• 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.
• 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.
• 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 1998

Study Registration Dates

• First Submitted: November 3, 1999
• First Submitted That Met QC Criteria: November 3, 1999
• First Posted (Estimated): November 4, 1999

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: February 12, 2024

More Information

Terms related to this study

• Keywords: Natural History; Parasite; Helminth Infection; Known Parasitic Infection; Suspected Parasitic Infection
• Additional Relevant MeSH Terms: Infections; Parasitic Diseases
• Other Study ID Numbers: 970096; 97-I-0096

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No