Clinical trial NCT03292224: Systemic Fungal Infections in ICU Patients
Official title: Systemic Fungal Infections in Intensive Care Unit Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fungal Infection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include patients who will be admitted to intensive care unit in Assiut University Hospital regardless to age and sex.

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Positive cultures of collected specimens from patients in ICU with suspected SFI.
timeFrame: 2weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Jensen J, Guinea J, Torres-Narbona M, Munoz P, Pelaez 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.
citation: Leleu G, Aegerter P, Guidet B; College des Utilisateurs de Base de Donnees en Reanimation. Systemic candidiasis in intensive care units: a multicenter, matched-cohort study. J Crit Care. 2002 Sep;17(3):168-75. doi: 10.1053/jcrc.2002.35815.
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.
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. doi: 10.1042/cs047015pa. No abstract available.