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

NCT03200275 | Completed DMC

• 1 other identifier: NMRR-17-50-34002
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 1

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.

Conditions

Legionella Pneumophila Pneumonia

Keywords

Legionella urine antigen test

Outcome Measures

Primary Outcomes (1)

• Legionella Pneumonia

  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

Study Arms (1)

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

Interventions

Immunocatch™ Legionella Urine Antigen Test DIAGNOSTIC_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.

HOSPITALISED PNEUMONIA PATIENTS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• More than 18 years of age,
• Hospitalized consecutively for pneumonia irrespective of it being community or hospital acquired.
• Acute symptoms of less than 2 weeks and radiological features which are compatible to pneumonia.

You may not qualify if:

• Under 18 years of age
• Suspected/confirmed case of active tuberculosis
• Patients who refused to give consent -

Sponsors & Collaborators

• Ministry of Health, Malaysia: lead

Study Sites (1)

Hospital Taiping

Taiping, Perak, 34000, Malaysia

Location

Related Publications (7)

• Touray S, Newstein MC, Lui JK, Harris M, Knox K. Legionella pneumophila cases in a community hospital: A 12-month retrospective review. SAGE Open Med. 2014 Oct 10;2:2050312114554673. doi: 10.1177/2050312114554673. eCollection 2014.

  PMID: 26770744 RESULT

• Diederen BM, Kluytmans JA, Vandenbroucke-Grauls CM, Peeters MF. Utility of real-time PCR for diagnosis of Legionnaires' disease in routine clinical practice. J Clin Microbiol. 2008 Feb;46(2):671-7. doi: 10.1128/JCM.01196-07. Epub 2007 Dec 19.

  PMID: 18094136 RESULT

• Farnham A, Alleyne L, Cimini D, Balter S. Legionnaires' disease incidence and risk factors, New York, New York, USA, 2002-2011. Emerg Infect Dis. 2014 Nov;20(11):1795-1802. doi: 10.3201/eid2011.131872.

  PMID: 25513657 RESULT

• Helbig JH, Uldum SA, Bernander S, Luck PC, Wewalka G, Abraham B, Gaia V, Harrison TG. Clinical utility of urinary antigen detection for diagnosis of community-acquired, travel-associated, and nosocomial legionnaires' disease. J Clin Microbiol. 2003 Feb;41(2):838-40. doi: 10.1128/JCM.41.2.838-840.2003.

  PMID: 12574296 RESULT

• Fiumefreddo R, Zaborsky R, Haeuptle J, Christ-Crain M, Trampuz A, Steffen I, Frei R, Muller B, Schuetz P. Clinical predictors for Legionella in patients presenting with community-acquired pneumonia to the emergency department. BMC Pulm Med. 2009 Jan 19;9:4. doi: 10.1186/1471-2466-9-4.

  PMID: 19152698 RESULT

• Levcovich A, Lazarovitch T, Moran-Gilad J, Peretz C, Yakunin E, Valinsky L, Weinberger M. Complex clinical and microbiological effects on Legionnaires' disease outcone; A retrospective cohort study. BMC Infect Dis. 2016 Feb 10;16:75. doi: 10.1186/s12879-016-1374-9.

  PMID: 26864322 RESULT

• Hollenbeck B, Dupont I, Mermel LA. How often is a work-up for Legionella pursued in patients with pneumonia? a retrospective study. BMC Infect Dis. 2011 Sep 7;11:237. doi: 10.1186/1471-2334-11-237.

  PMID: 21899763 RESULT

Study Officials

• ALBERT IRUTHIARAJ L ANTHONY, MBBS

  HOSPITAL TAIPING

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist/Principal Investigator

Study Record Dates

• First Submitted: June 24, 2017
• First Posted: June 27, 2017
• Study Start: September 12, 2017
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)