MalariaNCT00001645
Evaluation, Treatment and Monitoring of Patients With a Known or Suspected Parasitic Infection
An observational study of Malaria and Intestinal Worms, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Malaria, Intestinal Worms, GI Protozoa
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 1998to not given
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary clinical.
Who may be able to join
- Age 3 or over.
- Access to a primary medical care provider outside of the NIH
- Clinical evidence suggestive of a parasitic infection
Who cannot join
- Less than 3 years of age
- No evidence suggestive of a parasitic infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Malaria, Intestinal Worms, GI Protozoa, Echiniococcus, Strongyloides
- Keywords
- Helminth Infection, Parasite, Known Parasitic Infection, Suspected Parasitic Infection, Natural History
- Medical subject headings
- Malaria, Trematode Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start10 Oct 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thomas B Nutman, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001645
- Sponsor's protocol ID
- 970096
- Other IDs
- 97-I-0096
- Status last verified
- 11 Mar 2026
- First submitted
- 3 Nov 1999
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27181117O'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.
PubMed 26209897Nash 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.
PubMed 11389490Corda 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.
PubMed 35617367