Loopamp Mycoplasma P detection kit Evaluation Study

Loopamp Mycoplasma P detection kit Evaluation Study - Myco-LAMP Evaluation Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000006437

Enrollment

150

Registered

2011-09-30

Start date

2011-10-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Community acquired pneumonia (CAP) meeting the criteria of atypical pneumonia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Regardless of inpatient or outpatient. 2) Suspected CAP patient who presents a new typical infiltrative shadow on CXR or CT image taken <48 hr before this study and who shows at least one other typical symptom described below Coughing, or its exacerbation Purulent sputum or its deteriorating. Abnormal finding based on auscultation and percussion Breathing difficulties and/ or Tachypnea Fever with > 37 degree (axilla measurement) CRP increasing (in according to an criteria of each study site) Hypoxemia 3) Case which meets the criteria of 1) & 2) and which is suspected as atypical pneumoniae based on the policies to distinguish between atypical and bacterial pneumonia (Japanese Respiratory Society guidelines of community acquired pneumonia 2007) 4) Eligible patient who provides the informed consent signed by himself or his proxy.

Exclusion criteria

Exclusion criteria: 1) Patient for whom a clinical follow-up and a clear final diagnosis are judged to be difficult. 2) Patient who is obviously suspected to be TB, lung suppuration, pneumonia complicating with lung cancer or HIV.

Design outcomes

Primary

Measure	Time frame
Evaluate a clinical performance of Myco-LAMP for a pneumonia diagnosis in comparison of conventional IVDs and nucleic acid detection methodology. 1) Comparison of Myco-LAMP and serological test Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity) and an overall agreement rate between Myco-LAMP and serological test. 2) Comparison of Myco-LAMP and EIA (Immuno-Card) Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity) and an overall agreement rate between Myco-LAMP and EIA. 3) Comparison of Myco-LAMP and PCR Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity) and an overall agreement rate between Myco-LAMP and PCR	—

Measure

Time frame

Evaluate a clinical performance of Myco-LAMP for a pneumonia diagnosis in comparison of conventional IVDs and nucleic acid detection methodology. 1) Comparison of Myco-LAMP and serological test Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity) and an overall agreement rate between Myco-LAMP and serological test. 2) Comparison of Myco-LAMP and EIA (Immuno-Card) Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity) and an overall agreement rate between Myco-LAMP and EIA. 3) Comparison of Myco-LAMP and PCR Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity) and an overall agreement rate between Myco-LAMP and PCR

—

Countries

Japan

Contacts

Public ContactTaiga Miyazaki

Nagasaki evaluation organization for clinical interventions office

shinkin@peath.co.jp095-842-5402

Outcome results