Fungal Infection in Patients in Intensive Care Units
Primary Purpose
Fungal Infection
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Routine Laboratory investigations
Sponsored by
About this trial
This is an interventional screening trial for Fungal Infection
Eligibility Criteria
Inclusion Criteria:
- Adult Patients with liver cirrhosis that will be clinically suspected to have in- fection.
Exclusion Criteria:
- Age < 18 years
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cirrhotic ICU Patients
Arm Description
about 150 patients with cirrhosis fulfill- ing the inclusion criteria that will be admitted to Tropical Medicine and Gas- troenterology Department, Al-Rajhi Liver Hospital, Assiut University Hospi- tals) will be evaluated for fungal infection.
Outcomes
Primary Outcome Measures
frequency of fungal infection in cirrhotic patients
frequency of fungal infection in cirrhotic patients
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04684342
Brief Title
Fungal Infection in Patients in Intensive Care Units
Official Title
Predictors of Fungal Infection in Non-neutropenic Patients in Intensive Care Units
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Predictors of fungal infection in non-neutropenic patients in intensive care units and the aim of the study is To evaluate the frequency of fungal infection in non-neutropenic patients in Intensive Care Units.
To evaluate the risk factors of fungal infection in these patients.
Detailed Description
The incidence of candidemia in the overall population ranges from 1.7 to 10 episodes per 100,000 inhabitants and Candida is one of the ten leading causes of bloodstream infections in developed countries. An estimated 33-55% of all episodes of candidemia occur in intensive care units (ICU) and are associated with mortality rates ranging from 5% to 71%. Candida fungemia may have an endogenous or an exogenous origin, and in recent years a growing proportion of episodes of candidemia have been caused by Candida species other than albicans. The most important independent conditions predisposing to candidemia in ICU patients include prior abdominal surgery, intravascular catheters, acute renal failure, parenteral nutrition, broad-spectrum antibiotics, a prolonged ICU stay, the use of corticosteroids and mucosal colonization with Candida. In recent years, several studies have shown that ICU patients with mucosal Candida colonization, particularly if multifocal, are at a higher risk for invasive candidiasis, and that colonization selects a population amenable to antifungal prophylaxis or empirical therapy. Candidemia in ICUs is associated with a con- siderable increase in hospital costs and length of hospital stay.
Invasive fungal infection (IFI) is a grave infection associated with serious effects in patients with chronic diseases including liver cirrhosis. The diagnosis of IFI re- quires histopathological evidence of tissue invasion, or isolation in blood cultures, or isolation from a normally sterile body fluid or site, with samples collected intra-op- eratively or by percutaneous needle aspiration. Awareness of IFI has been increased in clinical practice with the increased survival of patients in immunocompromised states. Such infections are associated with a high morbidity and significant mortality, requiring early diagnosis and appropriate treatment, but also optimal prophylaxis in patients at high risk.
Globally, several studies had assessed fungal infections in non-neutropenic patients, however, to our knowledge, searching for fungal infections in these patients are un- derestimated in our locality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Infection
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cirrhotic ICU Patients
Arm Type
Experimental
Arm Description
about 150 patients with cirrhosis fulfill- ing the inclusion criteria that will be admitted to Tropical Medicine and Gas- troenterology Department, Al-Rajhi Liver Hospital, Assiut University Hospi- tals) will be evaluated for fungal infection.
Intervention Type
Diagnostic Test
Intervention Name(s)
Routine Laboratory investigations
Intervention Description
Complete blood picture
Liver function test and prothrombine time & concentration.
Blood urea and creatinine
Blood glucose, serum Na and K
CRP and ESR
Clinical specimens will be collected from patients according to the suspected site of infection (e.g. blood, urine, ascitic fluid, sputum or endo- tracheal aspirates) VITEK 2Compact inflammatory markers
Primary Outcome Measure Information:
Title
frequency of fungal infection in cirrhotic patients
Description
frequency of fungal infection in cirrhotic patients
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult Patients with liver cirrhosis that will be clinically suspected to have in- fection.
Exclusion Criteria:
Age < 18 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud A. Abdelmoula
Phone
01113983636
Ext
+2
Email
abdou.mahmoud93@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Zakaria, Professor
Organizational Affiliation
Assiut University
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
16399153
Citation
Leon DA, McCambridge J. Liver cirrhosis mortality rates in Britain from 1950 to 2002: an analysis of routine data. Lancet. 2006 Jan 7;367(9504):52-6. doi: 10.1016/S0140-6736(06)67924-5. Erratum In: Lancet. 2006 Feb 25;367(9511):650.
Results Reference
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PubMed Identifier
23463403
Citation
Runyon BA; AASLD. Introduction to the revised American Association for the Study of Liver Diseases Practice Guideline management of adult patients with ascites due to cirrhosis 2012. Hepatology. 2013 Apr;57(4):1651-3. doi: 10.1002/hep.26359. No abstract available.
Results Reference
background
PubMed Identifier
26916528
Citation
Bucsics T, Schwabl P, Mandorfer M, Peck-Radosavljevic M. Prognosis of cirrhotic patients with fungiascites and spontaneous fungal peritonitis (SFP). J Hepatol. 2016 Jun;64(6):1452-4. doi: 10.1016/j.jhep.2016.01.039. Epub 2016 Feb 23. No abstract available.
Results Reference
background
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Fungal Infection in Patients in Intensive Care Units
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