Mycoplasma PneumoniaeNCT02511262
Detection of Mycoplasma Pneumoniae
An observational study of Mycoplasma Pneumoniae, run by Meridian Bioscience, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mycoplasma Pneumoniae
- What is being tested?
- illumigene® Mycoplasma Direct, illumipro-10
- Type of treatment
- Medical device
- How many people
- 471 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cook Children's Healthcare System (CCHCS)
Fort Worth, Texas, 76104-2796
The Children's Mercy Hospital
Kansas City, Missouri, 64108
Sacred Heart Health System
Pensacola, Florida, 32513
About this study
Official title: Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay
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.
- Conditions
- Mycoplasma Pneumoniae
- Being tested
- illumigene® Mycoplasma Direct, illumipro-10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
illumigene® Mycoplasma Direct, illumipro-10Device
DNA amplification assay
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: illumigene® Mycoplasma Direct, illumipro-10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycoplasma PneumoniaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511262
- Sponsor's protocol ID
- CLIN-DHF-309-004.001
- Status last verified
- Feb 2016
- First submitted
- 28 Jul 2015
- Last updated
- 8 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay
- ClinicalTrials.gov ID
- NCT02511262
- Acronym / sponsor ID
- CLIN-DHF-309-004.001
- Conditions
- Mycoplasma Pneumoniae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Jan 2016 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specimen Collection | – | Device: illumigene® Mycoplasma Direct, illumipro-10Prospective patients with symptoms of upper respiratory infections which may be attributable to Mycoplasma pneumoniae, or from patients suspected of having Mycoplasma pneumoniae. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| illumigene® Mycoplasma Direct, illumipro-10DNA amplification assay | Device | Specimen Collection |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycoplasma Pneumoniae, run by Meridian Bioscience, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative detection of Mycoplasma Pneumoniae to aid in the diagnosis of M. pneumoniae infections. (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.