<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03292224</url>
  </required_header>
  <id_info>
    <org_study_id>SFI in ICU Patients</org_study_id>
    <nct_id>NCT03292224</nct_id>
  </id_info>
  <brief_title>Systemic Fungal Infections in ICU Patients</brief_title>
  <official_title>Systemic Fungal Infections in Intensive Care Unit Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to :&#xD;
&#xD;
        1. Diagnosis of Systemic fungal infections in ICU patients.&#xD;
&#xD;
        2. Detection the most common fungal species in ICU.&#xD;
&#xD;
        3. Detection of in vitro antifungal sensitivity pattern&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Systemic fungal infections are a significant and growing public health problem ,Over the past&#xD;
      few years, major advances in healthcare have led to an unwelcome increase in the number of&#xD;
      life-threatening infections due to true pathogenic and opportunistic fungi ,These have a&#xD;
      significant impact on morbidity, mortality, length of hospital stay, and healthcare costs in&#xD;
      critically ill patients in intensive care unit ( ICU).&#xD;
&#xD;
      Health care workers encounter at risk patients in ICU in various settings : including&#xD;
      diabetes mellitus, renal insufficiency, surgery (especially abdominal surgery), the use of&#xD;
      broad-spectrum antibiotics, parenteral nutrition, hemodialysis, mechanical ventilation, the&#xD;
      presence of central vascular catheters, and therapy with immunosuppressive agents,Prolonged&#xD;
      treatment with corticosteroids before ICU admission, liver cirrhosis with prolonged ICU stay&#xD;
      (.7 days), solid organ cancer, HIV infection and lung transplantation are also considered as&#xD;
      risk factors ,It can also occur following trauma or invasion of wounds covered with&#xD;
      contaminated dressings, e.g. in the ICU. One outbreak of gastric mucormycosis in ICU patients&#xD;
      reported in Spain arose in association with the use of contaminated wooden tongue depressors&#xD;
      in critically ill patients.&#xD;
&#xD;
      Candida and Aspergillus species are the most frequent causes of healthcare-associated fungal&#xD;
      infections in these patients, Although Candida infections are the most frequent fungal&#xD;
      infections in ICU patients, invasive aspergillosis is associated with higher morbidity and&#xD;
      mortality rates even in the absence of traditional risk factors,Invasive candidiasis is a&#xD;
      highly lethal infection associated with mortality rates between 40 and 60 %. The five most&#xD;
      common Candida species are Candida albicans, Candida glabrata, Candida tropicalis, Candida&#xD;
      parapsilosis, and Candida krusei.&#xD;
&#xD;
      Accurate diagnosis of invasive fungal infection is crucial so that appropriate antifungal&#xD;
      agents can be started rapidly. However, early diagnosis is not always easy. Microscopic&#xD;
      examination is rapid and can be helpful but a negative result does not exclude infection.&#xD;
      Blood cultures are positive in only 50-70 % of cases of Candida BSI, Furthermore, it can take&#xD;
      several days before Candida is identified at the species level and antifungal susceptibility&#xD;
      data are available but remain the gold stander in diagnosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 28, 2017</start_date>
  <completion_date type="Anticipated">October 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>Positive cultures of collected specimens from patients in ICU with suspected SFI.</measure>
    <time_frame>2weeks</time_frame>
    <description>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</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Fungal Infection</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>- Microscopic examination and culture of collected specimens</intervention_name>
    <description>Unstained wet mount with 10%-20% KOH.&#xD;
Wet mounts stained with:&#xD;
Lactophenol cotton blue.&#xD;
India ink&#xD;
Gram stain Culturing on Sabouraud´s dextrose agar .</description>
    <other_name>• Complete blood picture and Chest radiography.</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will include patients who will be admitted to intensive care unit in Assiut&#xD;
        University Hospital regardless to age and sex.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suppressed immunity such as: (patients with malignancy under chemotherapy, prolonged&#xD;
             use of corticosteroids.………etc)&#xD;
&#xD;
          -  Manifestations of chest infection e.g.cough, Haemoptysis, dyspnea and chest&#xD;
             discomfort.&#xD;
&#xD;
          -  Persistent fever resistant to antibiotic therapy.&#xD;
&#xD;
          -  Urinary manifestations resistant to antibiotic therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who received antifungal therapy within 3 days prior to sample collection.&#xD;
&#xD;
          -  Patients refused to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohamed zakaria, Dr</last_name>
    <phone>01001983060</phone>
    <email>m-z-abokrisha@yahoo.com</email>
  </overall_contact>
  <reference>
    <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>
    <PMID>19932132</PMID>
  </reference>
  <reference>
    <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>
    <PMID>12297992</PMID>
  </reference>
  <reference>
    <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>
    <PMID>26679628</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>4419464</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Shaimaa Selim</investigator_full_name>
    <investigator_title>Resident Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Mycoses</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03292224
org study id: SFI in ICU Patients
nct id: NCT03292224
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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
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.
observational model: Case-Only
time perspective: Prospective
measure: Positive cultures of collected specimens from patients in ICU with suspected SFI.
time frame: 2weeks
description: 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
intervention type: Diagnostic Test
intervention name: - Microscopic examination and culture of collected specimens
description: Unstained wet mount with 10%-20% KOH.
Wet mounts stained with:
Lactophenol cotton blue.
India ink
Gram stain Culturing on Sabouraud´s dextrose agar .
other name: • Complete blood picture and Chest radiography.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mohamed zakaria, Dr
phone: 01001983060
email: m-z-abokrisha@yahoo.com
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.
PMID: 19932132
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.
PMID: 12297992
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.
PMID: 26679628
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.
PMID: 4419464
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Shaimaa Selim
investigator title: Resident Doctor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Mycoses