Detection of Mycoplasma Pneumoniae

Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02511262

Enrollment

471

Registered

2015-07-30

Start date

2015-08-31

Completion date

Unknown

Last updated

2016-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycoplasma Pneumoniae

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.

Interventions

DEVICEillumigene® Mycoplasma Direct, illumipro-10

DNA amplification assay

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Qualitative detection of Mycoplasma Pneumoniae to aid in the diagnosis of M. pneumoniae infections.	Up to 14 days	Testing of each enrolled subject's samples will be performed within 14 days of collection.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026