Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Detection of Mycoplasma Pneumoniae

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02511262
Recruitment Status : Completed
First Posted : July 30, 2015
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Mycoplasma Pneumoniae Device: illumigene® Mycoplasma Direct, illumipro-10

Layout table for study information
Study Type : Observational
Actual Enrollment : 471 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay
Study Start Date : August 2015
Actual Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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




Primary Outcome Measures :
  1. Qualitative detection of Mycoplasma Pneumoniae to aid in the diagnosis of M. pneumoniae infections. [ Time Frame: Up to 14 days ]
    Testing of each enrolled subject's samples will be performed within 14 days of collection.


Biospecimen Retention:   Samples With DNA
Dual throat swabs.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511262


Locations
Layout table for location information
United States, Florida
Sacred Heart Health System
Pensacola, Florida, United States, 32513
United States, Missouri
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Texas
Cook Children's Healthcare System (CCHCS)
Ft. Worth, Texas, United States, 76104-2796
Sponsors and Collaborators
Meridian Bioscience, Inc.
Layout table for additonal information
Responsible Party: Meridian Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT02511262    
Other Study ID Numbers: CLIN-DHF-309-004.001
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Mycoplasma Infections
Pneumonia, Mycoplasma
Pneumonia
Pleuropneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pleurisy
Pleural Diseases
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial