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SIHAM Candidemia Network:An Observational Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01281345
First Posted: January 21, 2011
Last Update Posted: November 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Arunaloke Chakrabarti, Society of Indian Human & Animal Mycologist
  Purpose

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 Candida species from blood culture on ≥ 1 occasion during ICU stay)
  4. Blood culture positive for Candida spp. , if sample has been drawn within 48 hrs after discharge from the ICU.

Exclusion criteria:

1. Patient already diagnosed of candidemia before admission in ICU Variables|: types of ICU, demographic data of patients, underlying illness, risk factors, severity scores, diagnostic methods, treatment characteristics (Annexure II) and treatment outcomes (Annexure III)

Diagnosis of candidemia: Isolation of Candida species from blood culture (arterial/venous) by any method (conventional/ lysis-centrifugation/ automated system/ any other method). No intervention in diagnostic processes at any center. Centers not performing diagnosis of candidemia will be excluded from the study

Data recording: both manual and online. The form of Annexure II will be filled up within 5 days of diagnosis of candidemia; Annexure III will be filled up within 7 days of discharge from hospital or 30 days after starting the antifungal therapy or death of the patient (which over period is early).

Data analysis: appropriate statistical method will be employed for analysis of data.


Condition
Candidemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter Observational Study of Candidemia Among ICU Patients in India

Further study details as provided by Prof. Arunaloke Chakrabarti, Society of Indian Human & Animal Mycologist:

Primary Outcome Measures:
  • Death or discharge [ Time Frame: 30 days ]

Biospecimen Retention:   Samples With DNA
Candida isolates

Enrollment: 1400
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with candidemia diagnosed in ICUs > 48 h after admission during the study period will be included in each site
Criteria

Inclusion Criteria:

  • Admitted in ICUs for > 48 hour
  • All age group patients will be included (both adult & children)
  • Diagnosed as proven candidemia with isolation of Candida species ≥1 occasion from blood during ICU stay.
  • Blood culture positive for Candida spp. , if sample has been drawn within 48 hrs after discharge from the ICU.

Exclusion Criteria:

  • Patient already diagnosed for candidemia before admission in ICUs or in ICU for ≤48h .
  Contacts and Locations
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): NCT01281345


Locations
India
Arunaloke Chakrabarti
Chandigarh, UT, India, 160012
Sponsors and Collaborators
Society of Indian Human & Animal Mycologist
Investigators
Principal Investigator: Arunaloke Chakrabarti, MD PGIMER, Chandigarh
  More Information

Responsible Party: Prof. Arunaloke Chakrabarti, Professor, Society of Indian Human & Animal Mycologist
ClinicalTrials.gov Identifier: NCT01281345     History of Changes
Other Study ID Numbers: SIHAM_02
First Submitted: January 20, 2011
First Posted: January 21, 2011
Last Update Posted: November 19, 2014
Last Verified: January 2011

Keywords provided by Prof. Arunaloke Chakrabarti, Society of Indian Human & Animal Mycologist:
icu
candida
epidemiology
blood stream infection
candidemia

Additional relevant MeSH terms:
Candidemia
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Mycoses
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes