Detection of Mycoplasma Pneumoniae

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

471 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Mycoplasma Pneumoniae

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

illumigene® Mycoplasma Direct, illumipro-10

Intervention Type DEVICE

DNA amplification assay

Interventions

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illumigene® Mycoplasma Direct, illumipro-10

DNA amplification assay

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No