Impact of Legionella Urine Antigen Testing (LUAT) on the Local Epidemiology and Diagnosis of Legionella Pneumonia

July 27, 2019 updated by: ALBERT ANTHONY, Ministry of Health, Malaysia

The Impact of Legionella Urine Antigen Testing (LUAT) on the Local Epidemiology and Diagnosis of Legionella Pneumonia - A Hospital Based Study in Malaysia

There has never been a paper published or research done to determine the rate of Legionella species as a cause of community or nosocomial acquired pneumonia requiring hospitalization in Malaysia. Anecdotally, Legionnaires' disease is thought to be uncommon in Malaysia. This is one of the first prospective hospital-based studies to comprehensively evaluate the epidemiological and demographical factors of patients hospitalized with Legionella infection in Malaysia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Legionellosis is an environment-related, acute gram negative bacterial respiratory infection and is caused primarily by the species Legionella pneumophila, an atypical pulmonary pathogen, in the likes of mycoplasma and chlamydia species. Potentially all Legionella spp. may cause human disease, however, the majority (92%) of clinical cases are caused by L. pneumophila and the predominant serogroup is serogroup 1.

Globally, 1-5% of community acquired pneumonia patients is caused by Legionella spp. and is a challenge to public health authorities. The incidence of Legionella Pneumonia in the US has exceeded expectations and is increasing, with at least 13,000 cases occurring annually. In Singapore, Legionella spp. is responsible for 2-7% of cases of hospitalized community-acquired pneumonia.

Legionella pneumophila is being increasingly recognized as a common pathogen causing both community-acquired and nosocomial pneumonia that is responsible for significant morbidity and mortality. It is also one of the most common aetiology discovered when pneumonia is sufficiently severe to require admission to an intensive care unit. It's likely to cause a severe form of pneumonia with high likelihood of adverse medical outcomes which includes rapid deterioration, respiratory failure and the need for intensive care unit (ICU) admission.

It will be impossible to distinguish patients with Legionnaires' disease from patients with other types of pneumonia clinically. The key to diagnosis is to perform microbiologic testing when a patient is stratified into a high-risk category. Rapid diagnosis of these pneumonias is desired as delayed diagnosis and institution of appropriate antibiotics is associated with poor outcomes.

In routine clinical practice, legionellosis is rarely proven by culture whereas detection of urinary antigen is now common. In US and Europe, case detection rates were revolutionized with the usage of urine antigen test at 97% and 79% respectively. Urine antigen testing has a reported sensitivity that ranges between 76% and 86% for cases of Legionella pneumonia serogroup 1 and a specificity that approaches 100%.

In this region, urine antigen test is rarely done due to lack of clinical awareness, a perception that Legionella infection is uncommon and due to the lack of availability of this test regionally. The introduction of the immunochromatographic (ICT) membrane assay to detect antigenuria has revolutionized the usage of UAT to diagnose Legionella infections. The ICT assay is similar to a home pregnancy test and is commercially available. The test is simple to perform and does not require special laboratory equipment, and results can be obtained within 15 minutes. The investigators wish to utilize this innovation to test patients whom are hospitalized with pneumonia and determine the incidence of Legionella infection in the local setting.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
505

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Perak
      • Taiping, Perak, Malaysia, 34000
        • Hospital Taiping

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 503 patients who are consecutively hospitalised with pneumonia in Hospital Taiping from date of commencement of study.

Description

Inclusion Criteria:

  1. More than 18 years of age,
  2. Hospitalized consecutively for pneumonia irrespective of it being community or hospital acquired.

  3. Acute symptoms of less than 2 weeks and radiological features which are compatible to pneumonia.

    -

Exclusion Criteria:

  1. Under 18 years of age
  2. Suspected/confirmed case of active tuberculosis
  3. Patients who refused to give consent -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
HOSPITALISED PNEUMONIA PATIENTS

All patients of more than 18 years of age, hospitalized consecutively for pneumonia irrespective of it being community or hospital acquired. All the patients included in this study will need to have acute symptoms of less than 2 weeks and radiological features which are compatible to pneumonia.

They will undergo testing for Legionella pneumophila serogroup 1 urine antigen using a qualitative rapid assay following manufacturer's instructions at baseline. The diagnosis of Legionella pneumonia is made if the Immunocatch™ Legionella Urine Antigen Test is positive.
Diagnostic test: Immunocatch™ Legionella Urine Antigen Test
A total number of 503 urine specimens from study participants will be tested with LUAT - Immunocatch™. This test utilises the immunochromatographic (ICT) membrane assay to detect antigenuria which has revolutionized the usage of UAT to diagnose Legionella infections. The results can be obtained within minutes and the test does not require any sophisticated laboratory support. A comparison of the ICT with the Enzyme Immuno Assay (EIA) test showed comparable performance characteristics.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Legionella Pneumonia
Time Frame: 15 months
The diagnosis of Legionella pneumonia is made if the Legionella Urine Antigen Test is positive. The LUAT test kit utilized in this study will not be compared to the gold standard test for Legionellosis which would be the culture on specialised media/buffered-charcoal yeast extract (BCYE) plates, as this test is not available nationwide
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ministry of Health, Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ALBERT IRUTHIARAJ L ANTHONY, MBBS, Hospital Taiping

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NMRR-17-50-34002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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