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SIHAM Candidemia Network:An Observational Study

Society of Indian Human & Animal Mycologist · 2011
ClinicalTrials.gov · Datasets · License: Public Domain · 2011
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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: Site selection: A questionnaire will be circulated (annexure I) to all major tertiary care centers of India. The centers will be selected on the competence of candidemia diagnosis and availability ICU facilities. Expected number of centers \~ 20. Study period: October 1, 2010 - March 31, 2012 No of patients/sites: Consecutive all patients with candidemia detected during ICU stay over the study period will be included in the study in each site. Patient selection: Inclusion criteria: 1. Admitted in ICU for \> 48 hours (to coincide definitions of nosocomial or ICU-acquired) 2. All age group patients will be included (pediatric \& adult) 3. Diagnosed as proven candidemia (isolation of Can
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