Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01212042
First received: September 29, 2010
Last updated: April 30, 2015
Last verified: April 2015
  Purpose

Respiratory infections have a high associated morbidity and mortality, especially in immunocompromised patients. To initiate effective treatment of respiratory infections, it is essential that a rapid and thorough laboratory analysis of respiratory specimens be performed, given the wide range of pulmonary pathogens that can be detected in this population. Conventional microbiology is time-consuming and cumbersome, and the capability of local laboratories to assess specimens for rare or unusual pathogens is often limited. This study will evaluate if a newer technology can be effectively utilized in the identification of a broader range of infectious agents relative to conventional procedures.

Resequencing Pathogen Microarray (RPM) technology developed by TessArae , LLC which ceased operations in July 2014) uses a microarray chip to identify multiple pathogens in a clinical specimen. The technology has had limited clinical application, but early studies have shown its effectiveness in accurately identifying a large number of viral and bacterial organisms. In contrast to conventional microbiological procedures based on phenotypic traits (growth characteristic and enzymatic activity), this is microarray utilizes DNA sequence analysis to detect and identify the species, serotype/subtype, or strain of the infectious agent.

Aliquots of respiratory specimens (initially, specimens collected by bronchoalveolar lavage, BAL) from 200 patients at the NIH Clinical Center and the Washington Hospital Center will be analyzed using the customized microarray chip. The specimens will be collected as part of the patients routine clinical care. The results of the TessArray microarray analysis will not be available to the clinician and therefore will not have any effect on the clinical care of the patients.

The results of the microarray analysis from each site will be compared to that site s clinical laboratory results, and the data will be analyzed by site.


Condition
HIV

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The sensitivity, compared to standard microbiological methods, of a customized TessArray microarray for the diagnosis of respiratory infections. [ Time Frame: At time of enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: September 2010
Detailed Description:

Respiratory infections have a high associated morbidity and mortality, especially in immunocompromised patients. To initiate effective treatment of respiratory infections, it is essential that a rapid and thorough laboratory analysis of respiratory specimens be performed, given the wide range of pulmonary pathogens that can be detected in this population. Conventional microbiology is time-consuming and cumbersome, and the capability of local laboratories to assess specimens for rare or unusual pathogens is often limited. This study will evaluate if a newer technology can be effectively utilized in the identification of a broader range of infectious agents relative to conventional procedures.

Resequencing Pathogen Microarray (RPM) technology developed by TessArae , LLC which ceased operations in July 2014) uses a microarray chip to identify multiple pathogens in a clinical specimen. The technology has had limited clinical application, but early studies have shown its effectiveness in accurately identifying a large number of viral and bacterial organisms. In contrast to conventional microbiological procedures based on phenotypic traits (growth characteristic and enzymatic activity), this is microarray utilizes DNA sequence analysis to detect and identify the species, serotype/subtype, or strain of the infectious agent.

Aliquots of respiratory specimens (initially, specimens collected by bronchoalveolar lavage, BAL) from 200 patients at the NIH Clinical Center and the Washington Hospital Center will be analyzed using the customized microarray chip. The specimens will be collected as part of the patients routine clinical care. The results of the TessArray microarray analysis will not be available to the clinician and therefore will not have any effect on the clinical care of the patients.

The results of the microarray analysis from each site will be compared to that site s clinical laboratory results, and the data will be analyzed by site.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Subjects may be included in this study if they:

  1. Are 2 years of age and older.
  2. Are being evaluated for a respiratory infection.
  3. Are having respiratory specimens collected as part of their clinical evaluation.
  4. Agree to have specimens stored for future research.

EXCLUSION CRITERIA:

Patients unable or unwilling to give informed consent will be excluded from the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212042

Contacts
Contact: Maryellen McManus, R.N. (301) 451-4647 mcmanusm2@mail.nih.gov
Contact: Joseph A Kovacs, M.D. (301) 496-9907 jkovacs@mail.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: Joseph A Kovacs, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01212042     History of Changes
Other Study ID Numbers: 100200, 10-CC-0200
Study First Received: September 29, 2010
Last Updated: April 30, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Pneumonia
Pulmonary Pathogens
HIV
Immunocompromised Host
Respiratory Infection
Mycobacteria

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 01, 2015