Viral Infections in Healthy and Immunocompromised Hosts
- 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....
|Study Design:||Time Perspective: Prospective|
|Official Title:||Viral Infections in Healthy and Immunocompromised Hosts|
- The purpose of this study is to obtain sequential specimens containing virusesfrom both non-immunocompromised) and immunocompromised persons for one or more of the following:a) Study the evolution of the nucleotide sequence in viruses over ti... [ Time Frame: open ended ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
Viral infections are an important cause of morbidity and mortality in hospitalized patients as well as out-patients. New strains of viruses may appear and cause epidemics in healthy persons or immunocompromised persons. A better understanding of these new virus strains may help to control and prevent these infections. Some viral infections that would otherwise be asymptomatic or cause mild disease can be life threatening in immunocompromised persons. Immunocompromised persons often shed high titers of virus for prolonged periods of time. In the absence of a potent immune system, viruses may evolve more rapidly in their hosts. Therefore, analysis of sequential virus specimens from these patients can provide information on virus evolution, including how resistance to antiviral agents can develop. In addition, higher titers of virus may be associated with virus mutants that are more adapted to grow in cell culture. In this protocol we will obtain specimens containing viruses from otherwise healthy or immunocompromised patients over sequential periods of time to study their nucleic acid sequences, sensitivity to antiviral agents, and ability to grow in cell culture. We will also record the patient s signs and symptoms, note results of any pertinent laboratory work-up, and in some cases, obtain blood to measure immune responses or to look for viremia. This study should provide further understanding on how viruses evolve in their natural hosts, how they become resistant to antiviral agents, how antibody responses evolve to viruses, and might allow some currently uncultivatable viruses to be grown in cell culture.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306084
|Contact: Siu-Ping Turk, R.N.||(301) email@example.com|
|Contact: Jeffrey I Cohen, M.D.||firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Jeffrey I Cohen, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|