Detection of Mycoplasma Pneumoniae

Completed

• Conditions: Mycoplasma Pneumoniae
• Interventions: Device: illumigene® Mycoplasma Direct, illumipro-10

• Registration Number: NCT02511262
• Lead Sponsor: Meridian Bioscience, Inc.

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 Description

Not available

Study Timeline

• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-30
• Study Start: 2015-08
• Primary Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-05
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 471

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Specimen Collection	illumigene® Mycoplasma Direct, illumipro-10	Prospective patients with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae.

Primary Outcome Measures

Name	Time	Method
Qualitative detection of Mycoplasma Pneumoniae to aid in the diagnosis of M. pneumoniae infections.	Up to 14 days	Testing of each enrolled subject's samples will be performed within 14 days of collection.

Trial Locations

Locations (3)

The Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

Cook Children's Healthcare System (CCHCS); 🇺🇸 Ft. Worth, Texas, United States

Sacred Heart Health System; 🇺🇸 Pensacola, Florida, United States