Detection of Mycoplasma Pneumoniae

Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay

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.

Study Overview

• Status: Completed
• Conditions: Mycoplasma Pneumoniae
• Intervention / Treatment: Device: illumigene® Mycoplasma Direct, illumipro-10

• Study Type: Observational
• Enrollment (Actual): 471

Contacts and Locations

Study Locations

• United States
  • Florida
    • Pensacola, Florida, United States, 32513
      • Sacred Heart Health System
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • The Children's Mercy Hospital
  • Texas
    • Ft. Worth, Texas, United States, 76104-2796
      • Cook Children's Healthcare System (CCHCS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Prospective patients with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Specimen Collection; Prospective patients with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae.	Device: illumigene® Mycoplasma Direct, illumipro-10; DNA amplification assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Meridian Bioscience, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Estimate): February 8, 2016
• Last Update Submitted That Met QC Criteria: February 5, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pleural Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia, Bacterial; Pleurisy; Mycoplasmatales Infections; Pneumonia; Pleuropneumonia; Mycoplasma Infections; Pneumonia, Mycoplasma
• Other Study ID Numbers: CLIN-DHF-309-004.001