Clinical Trial: SIHAM Candidemia Network:An Observational Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Multicenter Observational Study of Candidemia Among ICU Patients in India

Brief Summary:

Title: A multicenter observational study of candidemia cases among ICU patients in India

Objective: Primary objective:

Determine epidemiological and also clinical parameters of candidemia cases among ICU patients in India.

Exploratory Objectives:

  1. Determine the prevalence of candidemia among ICU patients.
  2. Determine the prevalence of candidemia due to C. albicans and each species of non-albicans Candida species.
  3. Determine the demographics and risk factors for candidemia patients and comparison of relevant variables between the cases with C. albicans and non-albicans Candida species isolation.
  4. Describe physician practice in the management of candidemia cases - clinical and outcome.
  5. Determine the in-vitro antifungal susceptibilities of Candida isolates.

Study description and purpose:

Short description: Observational multicentre study in ICU patients. Study purpose: Epidemiological determinants of candidemia, management and outcome evaluation.

How the study would help? It would help to evaluate outcomes of current management strategies and to develop future better management strategies of candidemia cases.

Critical issues & risk: Site & center selection would be important No risk for patients included in the study as it is only observational study

Study design:

  • Objectives :

    1.1. Primary objective: Determine the epidemiological parameters of candidemia cases among ICU patients in India 1.2. Exploratory objectives

    1. Determine the prevalence of candidemia among ICU patients.
    2. Determine the prevalence of candidemia due to C. albicans and each species of non-albicans Candida species.
    3. Determine the demographics and risk factors for candidemia patients, and comparison of relevant variables between the cases with C. albicans and non-albicans Candida species isolation.
    4. Describe the management of candidemia cases and outcome.
    5. Determine the in-vitro antifungal susceptibility testing of Candida isolates.

  • Study description and purpose:

    2.1 Observational multicentre study of ICUs in India. Institute having ICUs and facility for diagnosis of candidemia will be chosen.

    2.2 Purpose: Determination of epidemiological parameter of candidemia, description of current management and outcome of patients with candidemia. This would help in formulation of a guideline for management of patients with candidemia especially when the patients are critically ill and admitted in ICUs.

    2.3 Critical issues & risk: There is no risk for patient as it only observational study and no intervention is intended. The site selection would be important to get useful data.