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

September 29, 2010
April 30, 2015
September 2010
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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 ]
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Complete list of historical versions of study NCT01212042 on ClinicalTrials.gov Archive Site
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Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections
Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections

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.

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.

Observational
Time Perspective: Prospective
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HIV
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
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  • 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.

Both
2 Years and older
No
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
United States
 
NCT01212042
100200, 10-CC-0200
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
Principal Investigator: Joseph A Kovacs, M.D. National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP