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
- Are there results?
- Not yet: the study is under way
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
- 30 Oct 2026
- First submitted
- 3 Nov 1999
- Last updated
- 3 Nov 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation, Treatment, and Monitoring of Patients With Known or Suspected Parasitic Infection
- ClinicalTrials.gov ID
- NCT00001645
- Acronym / sponsor ID
- 970096
- Conditions
- Malaria, Intestinal Worms, GI Protozoa, Echiniococcus, Strongyloides
- Keywords
- Helminth Infection, Parasite, Known Parasitic Infection, Suspected Parasitic Infection, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 10 Oct 1998 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary clinical.
Key inclusion criteria (3 listed)
- Age 3 or over.
- Access to a primary medical care provider outside of the NIH
- Clinical evidence suggestive of a parasitic infection
Key exclusion criteria (2 listed)
- Less than 3 years of age
- No evidence suggestive of a parasitic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 27181117Nutman 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.
- Background: PubMed 26209897O'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.
- Background: PubMed 11389490Nash 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.
- Derived from this study: PubMed 35617367Corda 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas B Nutman, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Intestinal Worms, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas B Nutman, M.D. ((301) 496-5399, tnutman@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001645, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.