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

NCT01439646 | Completed

• 1 other identifier: Rdhar India
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Antifungal Therapy

Keywords

empirical; ICU; high risk patient

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

Non neutropenic, ICU, empiric ,antifungals

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

Interventions

it is a retrospective study, hence no active intervention OTHER

since it is an observational restrospective study hence no active intervention is planned

Non neutropenic, ICU, empiric ,antifungals

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fortis Hospital, India: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Raja dhar

Kolkata, West Bengal, 700107, India

Location

Study Officials

• raja dhar, MD

  Fortis Hospital, Kolkata

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Pulmonologist

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 23, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

IN (1)