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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200275
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
ALBERT ANTHONY, Ministry of Health, Malaysia

Brief Summary:
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.

Condition or disease Intervention/treatment
Legionella Pneumophila Pneumonia Diagnostic Test: Immunocatch™ Legionella Urine Antigen Test

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.

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Study Type : Observational
Actual Enrollment : 505 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Impact of Legionella Urine Antigen Testing (LUAT) on the Local Epidemiology and Diagnosis of Legionella Pneumonia - A Hospital Based Study in Malaysia
Actual Study Start Date : September 12, 2017
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : May 15, 2019


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200275


Locations
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Malaysia
Hospital Taiping
Taiping, Perak, Malaysia, 34000
Sponsors and Collaborators
Ministry of Health, Malaysia
Investigators
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Principal Investigator: ALBERT IRUTHIARAJ L ANTHONY, MBBS HOSPITAL TAIPING
Publications of Results:

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Responsible Party: ALBERT ANTHONY, Pulmonologist/Principal Investigator, Ministry of Health, Malaysia
ClinicalTrials.gov Identifier: NCT03200275    
Other Study ID Numbers: NMRR-17-50-34002
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ALBERT ANTHONY, Ministry of Health, Malaysia:
Legionella urine antigen test
Additional relevant MeSH terms:
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Legionnaires' Disease
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Legionellosis
Gram-Negative Bacterial Infections
Bacterial Infections