Systemic Fungal Infections in ICU Patients

Fungal Infection Clinical Trial

Official title:

Systemic Fungal Infections in Intensive Care Unit Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03292224
• Other study ID #: SFI in ICU Patients
• Status: Not yet recruiting
• Phase: N/A
• First received: August 29, 2017
• Last updated: September 20, 2017
• Start date: September 28, 2017
• Est. completion date: October 15, 2019

Study information

• Verified date: September 2017
• Source: Assiut University
• Contact: Mohamed zakaria, Dr
• Phone: 01001983060
• Email: m-z-abokrisha[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims to :

1. Diagnosis of Systemic fungal infections in ICU patients.

2. Detection the most common fungal species in ICU.

3. Detection of in vitro antifungal sensitivity pattern

Description:

Systemic fungal infections are a significant and growing public health problem ,Over the past few years, major advances in healthcare have led to an unwelcome increase in the number of life-threatening infections due to true pathogenic and opportunistic fungi ,These have a significant impact on morbidity, mortality, length of hospital stay, and healthcare costs in critically ill patients in intensive care unit ( ICU).

Health care workers encounter at risk patients in ICU in various settings : including diabetes mellitus, renal insufficiency, surgery (especially abdominal surgery), the use of broad-spectrum antibiotics, parenteral nutrition, hemodialysis, mechanical ventilation, the presence of central vascular catheters, and therapy with immunosuppressive agents,Prolonged treatment with corticosteroids before ICU admission, liver cirrhosis with prolonged ICU stay (.7 days), solid organ cancer, HIV infection and lung transplantation are also considered as risk factors ,It can also occur following trauma or invasion of wounds covered with contaminated dressings, e.g. in the ICU. One outbreak of gastric mucormycosis in ICU patients reported in Spain arose in association with the use of contaminated wooden tongue depressors in critically ill patients.

Candida and Aspergillus species are the most frequent causes of healthcare-associated fungal infections in these patients, Although Candida infections are the most frequent fungal infections in ICU patients, invasive aspergillosis is associated with higher morbidity and mortality rates even in the absence of traditional risk factors,Invasive candidiasis is a highly lethal infection associated with mortality rates between 40 and 60 %. The five most common Candida species are Candida albicans, Candida glabrata, Candida tropicalis, Candida parapsilosis, and Candida krusei.

Accurate diagnosis of invasive fungal infection is crucial so that appropriate antifungal agents can be started rapidly. However, early diagnosis is not always easy. Microscopic examination is rapid and can be helpful but a negative result does not exclude infection. Blood cultures are positive in only 50-70 % of cases of Candida BSI, Furthermore, it can take several days before Candida is identified at the species level and antifungal susceptibility data are available but remain the gold stander in diagnosis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 15, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Suppressed immunity such as: (patients with malignancy under chemotherapy, prolonged use of corticosteroids.………etc)

• Manifestations of chest infection e.g.cough, Haemoptysis, dyspnea and chest discomfort.

• Persistent fever resistant to antibiotic therapy.

• Urinary manifestations resistant to antibiotic therapy.

Exclusion Criteria:

• Patients who received antifungal therapy within 3 days prior to sample collection.

• Patients refused to participate in the study.

Related Conditions & MeSH terms

• Communicable Diseases
• Fungal Infection
• Infection
• Mycoses

Intervention

Diagnostic Test:
• - Microscopic examination and culture of collected specimens
Unstained wet mount with 10%-20% KOH. Wet mounts stained with: Lactophenol cotton blue. India ink Gram stain Culturing on Sabouraud´s dextrose agar .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Jensen J, Guinea J, Torres-Narbona M, Muñoz P, Peláez T, Bouza E. Post-surgical invasive aspergillosis: an uncommon and under-appreciated entity. J Infect. 2010 Feb;60(2):162-7. doi: 10.1016/j.jinf.2009.11.005. Epub 2009 Nov 20. — View Citation

Leleu G, Aegerter P, Guidet B; Collège des Utilisateurs de Base de Données en Réanimation. Systemic candidiasis in intensive care units: a multicenter, matched-cohort study. J Crit Care. 2002 Sep;17(3):168-75. — View Citation

O'Keefe SJ, Sender PM, Clark CG, James WP. Proceedings: The dynamics of protein metabolism following operative trauma. Clin Sci Mol Med. 1974 Sep;47(3):15P. — View Citation

Pappas PG, Kauffman CA, Andes DR, Clancy CJ, Marr KA, Ostrosky-Zeichner L, Reboli AC, Schuster MG, Vazquez JA, Walsh TJ, Zaoutis TE, Sobel JD. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2016 Feb 15;62(4):e1-50. doi: 10.1093/cid/civ933. Epub 2015 Dec 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive cultures of collected specimens from patients in ICU with suspected SFI.	samples (blood ,urine and sputum) will be taken under complete aseptic precautions in sterile containers and carried immediately for culturing on sabouraud dextrose agar .Positive cultures help in early diagnosis of systemic fungal infections	2weeks