Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections

This study is currently recruiting participants.
Verified May 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01212042
First received: September 29, 2010
Last updated: March 14, 2014
Last verified: May 2013

September 29, 2010
March 14, 2014
September 2010
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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

Background:

- TessArray Resequencing Pathogen Microarray is a new technology that can identify multiple infectious agents in a single specimen. Researchers are interested in determining whether the technology can accurately identify the germs responsible for causing respiratory infections. Respiratory samples, such as sputum or cells and fluid from the lungs, will be collected and studied using this technique.

Objectives:

- To evaluate the effectiveness of using TessArray Resequencing Pathogen Microarray to examine and identify infectious agents in respiratory samples.

Eligibility:

- Individuals at least 2 years of age who are having respiratory samples collected as part of a doctor's evaluation.

Design:

  • Participants will be selected from individuals who are providing respiratory samples as part of treatment for an infection or for other medical reasons. A portion of the respiratory sample collected will be used for research purposes.
  • Participants will provide a blood sample during or up to 3 days before or after the collection of the respiratory sample.
  • Participants may be asked to provide a second blood sample 2 to 12 weeks after the first sample is taken.
  • Treatment will not be provided as part of this study.

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.

The TessArray -Resequencing Pathogen Microarray (RPM) technology (from TessArae , LLC) 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), the TessArray 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 TessArray microarray. 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 TessArray 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
  • Respiratory Infections
  • Fungal Pneumonia
  • Viral Pneumonia
  • Mycobacteria
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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: Jennifer M Cuellar-Rodriguez, M.D. (301) 451-3787 cuellarrodrigjm@mail.nih.gov
United States
 
NCT01212042
100200, 10-CC-0200
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
Principal Investigator: Jennifer M Cuellar-Rodriguez, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
May 2013

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