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NCT01212042 · ClinicalTrials.gov registry record

Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections

A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Terminated
Registry status
129
Enrollment target

NCT01212042 is a clinical trial that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 129 participants.

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The verdict

NCT01212042 was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

TERMINATED
Registry status
129 participants
Enrollment target

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.

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2010-09-01
Est. Completion 2016-04-05

What the Registry Record Tells You About NCT01212042

The ClinicalTrials.gov registry entry for NCT01212042 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01212042 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01212042 about?

NCT01212042 is a clinical study titled "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 pul...

What is the current status of trial NCT01212042?

This trial is currently terminated. The enrollment target is 129 participants. The study started on 2010-09-01. Estimated completion is 2016-04-05.

Who is sponsoring clinical trial NCT01212042?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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