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OpenTrials
Completed

NCT Number: NCT02511262

Detection of Mycoplasma Pneumoniae

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.

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Key information

Conditions

Mycoplasma Pneumoniae

Sex eligibility

All sexes

Study type

Observational

Primary location

Sacred Heart Health System, Pensacola, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

illumigene® Mycoplasma Direct, illumipro-10

Device

DNA amplification assay

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Meridian Bioscience, Inc.

Industry

Registry information

Official study title

Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay

Important dates

Study start
2015
Primary completion
2016
First posted
Jul 30, 2015
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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