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Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections

NCT01212042 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 129

Last updated 2018-04-05

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Joseph A Kovacs, M.D. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-01
Completion
2016-04-05

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01212042 on ClinicalTrials.gov