Candida Spp. in the Lower Respiratory Tract: Harmless Residents or Pathogen?

NCT00786903 | Completed DMC

• 1 other identifier: 19-322 ex 07/08
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

In critically ill patients Candida spp. are frequently isolated from respiratory tract secretions such as endotracheal aspirates and bronchoalveolar lavages (BAL) and are most often considered as colonizers of the respiratory tract. In contrast, pneumonia due to infection with Candida spp. is rare and is diagnosed by histological demonstration of the yeast in lung tissue with associated inflammation. In spite of this, preemptive antifungal therapy based on isolation of Candida spp. from the respiratory tract is often initiated in critically ill patients. The disadvantages of this approach include increased selective pressure for the development of antimicrobial resistance, potential risks of adverse drug reactions and high treatment costs. On the other hand, immediate administration of appropriate antifungal therapy has been shown to be an important predictor of favorable outcome for patients with invasive fungal infections. Therefore, the development of reliable diagnostic measures for the detection of invasive pulmonary candidiasis is crucial. The overall objective of the proposed research project is to identify diagnostic strategies to differentiate between Candida colonization and Candida infection of the lower respiratory tract in critically ill patients. The proposed projects intends to test the hypothesis that 1.) invasive Candida strains from the lower respiratory tract differ from colonizing Candida strains with regard to production and expression of putative virulence factors and/or that 2.) patients suffering from pulmonary invasive candidiasis differ from patients colonized by Candida spp. with regard to inflammatory markers, other serum markers (fungal antigen) and composition of indigenous pulmonary bacterial flora.

Conditions

Pulmonary Candidiasis; Invasive Candidiasis

Outcome Measures

Primary Outcomes (1)

• pathogenic relevance of Candida in lower respiratory tract

  3 years

Eligibility Criteria

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

Study Population

adult patients with and without infiltration of the lungs and with and without intubation and mechanically ventilation

You may qualify if:

• depending on study group; i.e. no pathology of the lungs in group 1, and 4; underlying disease of the lungs in group 2 (i.e. sarcoidosis etc), infiltration of the lungs in group 3,4,5

You may not qualify if:

• depending on study group: i.e. HIV, recent antifungal therapy, age below 18

Sponsors & Collaborators

• Robert Krause, MD: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8043, Austria

Location

Related Publications (2)

• Krause R, Zollner-Schwetz I, Salzer HJ, Valentin T, Rabensteiner J, Pruller F, Raggam R, Meinitzer A, Prattes J, Rinner B, Strohmaier H, Quehenberger F, Strunk D, Heidrich K, Buzina W, Hoenigl M. Elevated levels of interleukin 17A and kynurenine in candidemic patients, compared with levels in noncandidemic patients in the intensive care unit and those in healthy controls. J Infect Dis. 2015 Feb 1;211(3):445-51. doi: 10.1093/infdis/jiu468. Epub 2014 Aug 22.

  PMID: 25149761 DERIVED

• Pruller F, Wagner J, Raggam RB, Hoenigl M, Kessler HH, Truschnig-Wilders M, Krause R. Automation of serum (1-->3)-beta-D-glucan testing allows reliable and rapid discrimination of patients with and without candidemia. Med Mycol. 2014 Jul;52(5):455-61. doi: 10.1093/mmy/myu023. Epub 2014 Jun 6.

  PMID: 24906361 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Respiratory secretions, blood, lung tissue

MeSH Terms

Conditions

Candidiasis, Invasive

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Study Officials

• Robert Krause, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Section of Infectious Diseases and Tropical Medicine, Department of Internal Medicine, Medical University of Graz

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: November 1, 2008
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

AU (1)