Viral Infections in Healthy and Immunocompromised Hosts
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/6/2019 |
| Start Date: | March 15, 2011 |
Background:
- 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.
Objectives:
- To collect samples and data from individuals who have been exposed to or have contracted
viral infections.
Eligibility:
- 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.
Design:
- 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.
- 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.
Objectives:
- To collect samples and data from individuals who have been exposed to or have contracted
viral infections.
Eligibility:
- 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.
Design:
- 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.
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, cell types infected by the virus, and
ability to grow in cell culture. In some cases we weill review tissue biosies or clinical
reports from outside laboratories to assist with the diagnosis of virus-associated diseases.
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, isolate
antibodies, 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.
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, cell types infected by the virus, and
ability to grow in cell culture. In some cases we weill review tissue biosies or clinical
reports from outside laboratories to assist with the diagnosis of virus-associated diseases.
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, isolate
antibodies, 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.
- INCLUSION CRITERIA:
1. The protocol is open to people of all ages.
2. Pregnant women are eligible.
3. Breast-feeding women are also eligible to participate
4. Must have (or be suspected of having) a viral infection, that is of interest to
LID investigators.0 Alternatively, must be a close contact of someone who has (or
is suspected of having) a viral infection that is of interest to LID
investigators.
5. Adults who are unable to provide initial consent may be enrolled providing
procedures per MEC policy MAS M87-4 have been followed.
EXCLUSION CRITERIA:
1. Patients who are unable to safely undergo study procedures and tests.
2. Patients unwilling to have samples collected and stored for future use.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
Click here to add this to my saved trials
