Detection of Mycoplasma Pneumoniae

Mycoplasma Pneumoniae Clinical Trial

Official title:

Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511262
• Other study ID #: CLIN-DHF-309-004.001
• Status: Completed
• Phase: N/A
• First received: July 28, 2015
• Last updated: February 5, 2016
• Start date: August 2015

Study information

• Verified date: February 2016
• Source: Meridian Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mycoplasma Infections
• Mycoplasma Pneumoniae
• Pleuropneumonia
• Pneumonia
• Pneumonia, Mycoplasma

Intervention

Device:
• illumigene® Mycoplasma Direct, illumipro-10
DNA amplification assay

Locations

Country	Name	City	State
United States	Cook Children's Healthcare System (CCHCS)	Ft. Worth	Texas
United States	The Children's Mercy Hospital	Kansas City	Missouri
United States	Sacred Heart Health System	Pensacola	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Meridian Bioscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No