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

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ClinicalTrials.gov Identifier: NCT01439646
Recruitment Status : Completed
First Posted : September 23, 2011
Last Update Posted : August 13, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dr Raja Dhar, Fortis Hospital, India

Brief 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

Condition or disease Intervention/treatment
Antifungal Therapy Other: it is a retrospective study, hence no active intervention

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 100 participants
Time Perspective: Retrospective
Official Title: Observational, Retrospective Study to Evaluate the Clinical Outcome in High Risk Patients Who Received Empirical Antifungal Therapy
Study Start Date : August 2011
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439646

Raja dhar
Kolkata, West Bengal, India, 700107
Sponsors and Collaborators
Fortis Hospital, India
Merck Sharp & Dohme Corp.
Principal Investigator: raja dhar, MD Fortis Hospital, Kolkata

Responsible Party: Dr Raja Dhar, Consultant Pulmonologist, Fortis Hospital, India
ClinicalTrials.gov Identifier: NCT01439646     History of Changes
Other Study ID Numbers: Rdhar India
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by Dr Raja Dhar, Fortis Hospital, India:
high risk patient

Additional relevant MeSH terms:
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors