NCT02511262|Completed
Detection of Mycoplasma Pneumoniae
Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay
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Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay
Sponsor study identifier
observational
471
1 country
3
Study Start
August 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
Not reported
Date not reportedThe objective of this Clinical Trial is to define the methods to be used to document that illumigene® Mycoplasma Direct meets its intended use claims, using the illumipro instrument, with throat swab samples collected from symptomatic patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 28, 2015
Actual (reported)July 30, 2015
Actual (reported)August 2015
Date type not reportedThis date has not been verified as actual or estimated.
January 2016
Actual (reported)Qualitative detection of Mycoplasma Pneumoniae to aid in the diagnosis of M. pneumoniae infections.
Testing of each enrolled subject's samples will be performed within 14 days of collection.
Up to 14 days
Prospective patients with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae.
DNA amplification assay
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Prospective patients with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae.
Sacred Heart Health System
Pensacola, Florida, 32513, United States
The Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Cook Children's Healthcare System (CCHCS)
Fort Worth, Texas, 76104-2796, United States
Dual throat swabs.
471 participants (actual enrollment reported by the registry).
First Submitted
July 28, 2015
First Posted
July 30, 2015
Study Start
August 2015
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2016
Actual (reported)Last Updated
February 8, 2016
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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