Detection of Mycoplasma Pneumoniae

Completed

Conditions studied: Mycoplasma Pneumoniae

In brief

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.

Key facts

Study ID

NCT02511262

Run by

Meridian Bioscience, Inc.

People needed

471

Starts

2015-08-01

Last updated by the study team

2016-02-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject has willingly given written informed consent.
• Specimens provided from subjects with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae.
• Dual throat swab collected per subject.

You may not qualify if…

• Subjects who are unwilling to sign the written informed consent.
• Multiple sets of specimens collected from the same subject.
• Subjects who are unwilling or unable to provide the required number of throat swabs.

Where it is running

• Sacred Heart Health System — Pensacola, Florida, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• Cook Children's Healthcare System (CCHCS) — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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