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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Fortis Hospital, India.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dr Raja Dhar, Fortis Hospital, India
ClinicalTrials.gov Identifier:
NCT01439646
First received: September 21, 2011
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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 Intervention
Antifungal Therapy
Other: it is a retrospective study, hence no active intervention

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Observational, Retrospective Study to Evaluate the Clinical Outcome in High Risk Patients Who Received Empirical Antifungal Therapy

Resource links provided by NLM:


Further study details as provided by Fortis Hospital, India:

Primary Outcome Measures:
  • Mortality both Short term (while on antifungal therapy) and Long term (within 12 weeks of completion of antifungal therapy) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean Duration of ICU (Intensive Care Unit) / HDU (High Dependency Unit stay after initiation of Antifungal Therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The common pathogens associated with Invasive Fungal Infections [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The common empirical antifungal agents used in suspected Invasive Fungal Infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The mean time for initiation of Antifungal therapy after suspicion of invasive fungal infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The risk factors in patients with proven/probable invasive fungal infections [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The appropriateness of antifungal agent based on microbiological and/or clinical outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439646

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

No publications provided

Responsible Party: Dr Raja Dhar, Consultant Pulmonologist, Fortis Hospital, India
ClinicalTrials.gov Identifier: NCT01439646     History of Changes
Other Study ID Numbers: Rdhar India
Study First Received: September 21, 2011
Last Updated: September 22, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Fortis Hospital, India:
empirical
ICU
high risk patient

Additional relevant MeSH terms:
Antifungal Agents
Clotrimazole
Miconazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014