NCT02511262

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
471

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

5 months

First QC Date

July 28, 2015

Last Update Submit

February 5, 2016

Conditions

Mycoplasma Pneumoniae

Outcome Measures

Primary Outcomes (1)

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

    Testing of each enrolled subject's samples will be performed within 14 days of collection.

    Up to 14 days

Study Arms (1)

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

Interventions

illumigene® Mycoplasma Direct, illumipro-10DEVICE

DNA amplification assay

Specimen Collection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sacred Heart Health System

Pensacola, Florida, 32513, United States

Location

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cook Children's Healthcare System (CCHCS)

Fort Worth, Texas, 76104-2796, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Dual throat swabs.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2015

First Posted

July 30, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2016

Last Updated

February 8, 2016

Record last verified: 2016-02

Locations

US(3)