Study to Evaluate the Clinical Outcome in High Risk Patients Who Received Empirical Antifungal Therapy

Observational, Retrospective Study to Evaluate the Clinical Outcome in High Risk Patients Who Received Empirical Antifungal Therapy

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

Study Overview

• Status: Completed
• Conditions: Antifungal Therapy
• Intervention / Treatment: Other: it is a retrospective study, hence no active intervention

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

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• India
  • West Bengal
    • Kolkata, West Bengal, India, 700107
      • Raja dhar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• All Non-neutropenic patients (18-75yrs) 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non neutropenic, ICU, empiric ,antifungals	Other: it is a retrospective study, hence no active intervention; since it is an observational restrospective study hence no active intervention is planned

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality both Short term (while on antifungal therapy) and Long term (within 12 weeks of completion of antifungal therapy)	6 months
Mean Duration of ICU (Intensive Care Unit) / HDU (High Dependency Unit stay after initiation of Antifungal Therapy	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The common pathogens associated with Invasive Fungal Infections	6 months
The common empirical antifungal agents used in suspected Invasive Fungal Infection	6 months
The mean time for initiation of Antifungal therapy after suspicion of invasive fungal infection	6 months
The risk factors in patients with proven/probable invasive fungal infections	6 months
The appropriateness of antifungal agent based on microbiological and/or clinical outcome	6 months

Collaborators and Investigators

• Sponsor: Fortis Hospital, India
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: raja dhar, MD, Fortis Hospital, Kolkata

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: September 21, 2011
• First Submitted That Met QC Criteria: September 22, 2011
• First Posted (Estimate): September 23, 2011

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 11, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: ICU; empirical; high risk patient
• Other Study ID Numbers: Rdhar India