Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections

Conditions
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HIV

Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Subjects may be included in this study if they: Are 2 years of age and older. Are being evaluated for a respiratory infection. Are having respiratory specimens collected as part of their clinical evaluation. Agree to have specimens stored for future research. EXCLUSION CRITERIA: Patients unable or unwilling to give informed consent will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity, compared to standard microbiological methods, of a customized TessArray microarray for the diagnosis of respiratory infections. |  | At time of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia, Pulmonary Pathogens, HIV, Immunocompromised Host, Respiratory Infection, Mycobacteria