CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 505 enrolled
Drug / intervention
Immunocatch™ Legionella Urine Antigen Testother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03200275
NCT03200275N/ACompleted
CompareCT.gov

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

Ministry of Health, Malaysia·observational·Posted Jun 27, 2017·Updated Jul 30, 2019

In Brief

An observational study evaluating Immunocatch™ Legionella Urine Antigen Test for Legionella Pneumophila Pneumonia. Completed, enrolled 505 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsLegionella Pneumophila Pneumonia
CountriesMalaysia
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 27, 2017
Enrollment StartSep 12, 2017
Primary CompletionMay 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.0 years ago

Interventions

Immunocatch™ Legionella Urine Antigen Testother

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.