Viral Infections in Healthy and Immunocompromised Hosts

This study is currently recruiting participants.
Verified October 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01306084
First received: February 26, 2011
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

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....

Condition
Virus Infections
Respiratory Viruses
Norovirus
Suspected Viral Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Viral Infections in Healthy and Immunocompromised Hosts

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 200
Study Start Date: February 2011
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. The protocol is open to people of all ages. Pregnant women are eligible.
    2. 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.
    3. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306084

Contacts
Contact: Siu-Ping Turk, R.N. (301) 451-7661 sturk@cc.nih.gov
Contact: Jeffrey I Cohen, M.D. jcohen@niaid.nih.gov

Locations
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    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Jeffrey I Cohen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01306084     History of Changes
Other Study ID Numbers: 110109, 11-I-0109
Study First Received: February 26, 2011
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Respiratory Infections
Norovirus
Adenovirus
Viral Infection
Respiratory Viruses

Additional relevant MeSH terms:
Virus Diseases

ClinicalTrials.gov processed this record on April 23, 2014