Fungal Infection in Patients in Intensive Care Units

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04684342
Collaborator
(none)
150
1
13.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Routine Laboratory investigations
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Predictors of Fungal Infection in Non-neutropenic Patients in Intensive Care Units
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: cirrhotic ICU Patients

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.

Diagnostic Test: Routine Laboratory investigations
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

Outcome Measures

Primary Outcome Measures

  1. frequency of fungal infection in cirrhotic patients [4 months]

    frequency of fungal infection in cirrhotic patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult Patients with liver cirrhosis that will be clinically suspected to have in- fection.
Exclusion Criteria:
  • Age < 18 years

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Mohamed Zakaria, Professor, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mahmoud Abdou Mahmoud, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04684342
Other Study ID Numbers:
  • Fungal infection in ICU
First Posted:
Dec 24, 2020
Last Update Posted:
Dec 28, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2020