Detection of Mycoplasma Pneumoniae

Brief Title

Detection of Mycoplasma Pneumoniae

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.
    



Study Type

Observational


Primary Outcome

Qualitative detection of Mycoplasma Pneumoniae to aid in the diagnosis of M. pneumoniae infections.


Condition

Mycoplasma Pneumoniae

Intervention

illumigene® Mycoplasma Direct, illumipro-10

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

471

Start Date

August 2015


Primary Completion Date

January 2016

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02511262

Organization ID

CLIN-DHF-309-004.001


Responsible Party

Sponsor

Study Sponsor

Meridian Bioscience, Inc.


Study Sponsor

, , 


Verification Date

February 2016