Study to Evaluate the Clinical Outcome in High Risk Patients Who Received Empirical Antifungal Therapy
Condition: Antifungal Therapy
Study type: Observational

Summary: 
      Retrospective, observational study To study the effect of Empirical Antifungal therapy on
      clinical outcome in high risk patients with suspected Invasive Fungal Infection admitted in
      ICU/Critical care unit, To know the current epidemiology of IFI and management approach in
      patients at high risk of Invasive fungal infections, Identify the risk factors associated
      with Invasive fungal infections, To comment on the appropriateness of empirical therapy used
      based on proven/probable diagnosis
    

Detailed description: 
      Study Objectives

      Primary Objective:

      - To study the effect of Empirical Antifungal therapy on clinical outcome in high risk
      patients with suspected Invasive Fungal Infection admitted in ICU/Critical care unit

        -  Secondary Objectives:

             1. To know the current epidemiology of IFI and management approach in patients at high
                risk of Invasive fungal infections

             2. Identify the risk factors associated with Invasive fungal infections

             3. To comment on the appropriateness of empirical therapy used based on
                proven/probable diagnosis

                Inclusion criteria:

                All Non-neutropenic patients admitted in the intensive care/critical care unit who
                are prescribed any form of pre-emptive / empirical Antifungal therapy during the
                specified study duration period

                Exclusion criteria:

                Neutropenic patients Patients with proven invasive fungal infections where
                antifungal therapy was initiated after the confirmation of Invasive fungal
                infection/Candidemia Patients who received prophylactic antifungal agents

                Study Design

        -  Multi Center (Dual-center - Fortis Hospital and Apollo Hospital) Retrospective,
           Observational Study

        -  Study Patients: 100 in number

      Retrospective data will be collected for all patients admitted in intensive care
      unit/Critical care unit (under the study investigators) who received any form of Empirical /
      Preemptive (not prophylactic) Antifungal therapy (of any duration, irrespective of culture
      positivity) as a suspected case of Invasive Fungal Infection.

      Following details of patients will be captured

      Demographics, primary and secondary diagnosis, co-morbidities, grade of infection, severity
      of sepsis and disease.

      Daily hemodynamic parameters, routine blood tests including Total count and hematologic
      profile, renal profile, Liver function tests, electrolyte status, additional tests whatever
      was done as a course of the therapy.

      Fungal C/S reports and any other sample culture reports

      Duration of treatment, Changes in therapy, Adjuvant therapy - for relevant cases, Any
      Surgical procedures undertaken: e.g., surgical debridement, fasciotomy and dressing (as a
      part of the standard treatment according to available guidelines) - for relevant cases, Any
      additional invasive procedure (eg: Mechanical ventilation ), Reported adverse events

      Recording of Risk factors for invasive fungal infections as detailed but not limited to:

        1. Diabetes,

        2. Use of immunosuppressants (Eg. steroids)

        3. Chronic Hemodialysis , TPN, Mechanical ventilation ,

        4. Sepsis/Septic shock, Multiorgan dysfunction (more than one organ),

        5. Non response to > 4 days of broad spectrum antibiotics,

        6. Structural lung disease,

        7. Major abdominal surgery,

        8. Multifocal colonization

             -  Study Duration:

      A period of one year starting backwards from December 2010 till January 2010.( max. 100
      patients retrospectively tracking back from Dec 2010 whichever comes first ).

      Statistical analysis

      Appropriate statistical tools such as "Multiple logistic regressions" model will be used to
      analyze linkages between different parameters recorded in the study

      Primary Endpoint:

        1. Mortality both Short term (while on antifungal therapy) and Long term (within 12 weeks
           of completion of antifungal therapy)

        2. Mean Duration of ICU (Intensive Care Unit) / HDU (High Dependency Unit stay after
           initiation of Antifungal Therapy

      Secondary Endpoints:

      The common pathogens associated with Invasive Fungal Infections

      The common empirical antifungal agents used in suspected Invasive Fungal Infection

      The mean time for initiation of Antifungal therapy after suspicion of invasive fungal
      infection.

      The mean duration of antifungal therapy

      The risk factors in patients with proven/probable invasive fungal infections

      The appropriateness of antifungal agent based on microbiological and/or clinical outcome
    

Intervention name(s): it is a retrospective study, hence no active intervention
Intervention type(s): Other
Intervention description(s): since it is an observational restrospective study hence no active intervention is planned
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        100 patients , nonneutropenic in ICU who have risk factors for fungal infections and are
        started empiricaly on antifungals
      
Keywords: empirical; ICU; high risk patient