|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | February 28, 2009 | ||||||||
| Start Date ICMJE | March 1997 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00001645 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation, Treatment and Monitoring of Patients With a Known or Suspected Parasitic Infection | ||||||||
| Official Title ICMJE | Evaluation, Treatment, and Monitoring of Patients With Known or Suspected Parasitic Infection | ||||||||
| 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. |
||||||||
| Detailed Description | This study is designed as a prospective study to evaluate and treat patients with parasitic infection. Up to 300 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 Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 300 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE |
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. |
||||||||
| Gender | Both | ||||||||
| Ages | 1 Year to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001645 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 970096, 97-I-0096 | ||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | January 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
