Clinical Trial: Detection of Mycoplasma Pneumoniae

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay

Brief Summary: The 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.

Detailed Summary:
Sponsor: Meridian Bioscience, Inc.

Current Primary Outcome: Qualitative detection of Mycoplasma Pneumoniae to aid in the diagnosis of M. pneumoniae infections. [ Time Frame: Up to 14 days ]

Testing of each enrolled subject's samples will be performed within 14 days of collection.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Meridian Bioscience, Inc.

Dates:
Date Received: July 28, 2015
Date Started: August 2015
Date Completion:
Last Updated: February 5, 2016
Last Verified: February 2016