Viral Infections in Healthy and Immunocompromised Hosts
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|ClinicalTrials.gov Identifier: NCT01306084|
Recruitment Status : Enrolling by invitation
First Posted : March 1, 2011
Last Update Posted : July 12, 2019
- Viral infections are an important cause of illness and death in hospitalized patients as well as outpatients. New strains of viruses may appear and infect both healthy people and those with weak immune systems. A better understanding of these new virus strains may help to control and prevent these infections. In particular, some viral infections that are less problematic in healthy persons can be life threatening in persons with weak immune systems, and viruses may be able to evolve more rapidly in persons with weak immune systems and therefore develop resistance to existing treatments. Researchers are interested in collecting samples and information from otherwise healthy persons or persons with weak immune systems to study the effects of viruses and their development.
- To collect samples and data from individuals who have been exposed to or have contracted viral infections.
- Individuals of all ages who have been diagnosed with a viral infection are suspected to have a viral infection, or have been in close contact with someone with a suspected or actual viral infection that is of interest to investigators in the Laboratory of Infectious Diseases.
- Healthy persons and persons with weak immune systems (immunocompromised individuals) are eligible to participate.
- Participants will be initially screened with a review of the medical records and if eligible a history and physical will be performed.
- Study procedures may include blood, stool, urine, saliva, or nasal fluid samples, and throat and genital swabs. For participants who have a specialized sample collection procedure as part of their medical care (e.g., spinal tap, bronchoscopy, liver biopsy), researchers may collect leftover samples from the clinical laboratory for testing.
- Samples may be collected up to four times per week during the first 2 weeks after enrollment in the study, and then as many as two times per week for up to 1 year. The number of study visits will be determined by the study researchers, and will depend on the virus being studied. Some participants may be asked to continue providing samples for longer than 1 year if there is concern for recurrence or relapse of the infection or if the study researchers feel that there are other reasons where it would be important to follow the viral infection.
- For otherwise healthy persons who have been exposed to a viral infection, an initial specimen will be collected and then up to three additional specimens may be collected over 1 year.
- Treatment will not be offered under this study.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||164 participants|
|Official Title:||Viral Infections in Healthy and Immunocompromised Hosts|
|Actual Study Start Date :||March 5, 2011|
- Sample collection, analysis of immune function, or review of tissue bx or clinical reports from outside labs in designated populations w/viral infections, suspected of having a viral infection, recovered from a viral infection or a close contact... [ Time Frame: open ended ]January 2021
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306084
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Jeffrey I Cohen, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|