Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections
|First Received Date ICMJE||September 29, 2010|
|Last Updated Date||June 6, 2014|
|Start Date ICMJE||September 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01212042 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections|
|Official Title ICMJE||Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections|
- 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.
- To evaluate the effectiveness of using TessArray Resequencing Pathogen Microarray to examine and identify infectious agents in respiratory samples.
- Individuals at least 2 years of age who are having respiratory samples collected as part of a doctor's evaluation.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||250|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Subjects may be included in this study if they:
Patients unable or unwilling to give informed consent will be excluded from the study.
|Ages||2 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01212042|
|Other Study ID Numbers ICMJE||100200, 10-CC-0200|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||National Institutes of Health Clinical Center (CC)|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP