SIHAM Candidemia Network:An Observational Study

NCT01281345 | Completed

• 1 other identifier: SIHAM_02
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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. 1.Determine the prevalence of candidemia among ICU patients.
2. 2.Determine the prevalence of candidemia due to C. albicans and each species of non-albicans Candida species.
3. 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. 4.Describe physician practice in the management of candidemia cases - clinical and outcome.
5. 5.Determine the in-vitro antifungal susceptibilities of Candida isolates.
6. 6.Admitted in ICU for \> 48 hours (to coincide definitions of nosocomial or ICU-acquired)
7. 7.All age group patients will be included (pediatric \& adult)
8. 8.Diagnosed as proven candidemia (isolation of Candida species from blood culture on ≥ 1 occasion during ICU stay)
9. 9.Blood culture positive for Candida spp. , if sample has been drawn within 48 hrs after discharge from the ICU.

Conditions

Candidemia

Keywords

icu; candida; epidemiology; blood stream infection; candidemia

Outcome Measures

Primary Outcomes (1)

• Death or discharge

  30 days

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Patient already diagnosed for candidemia before admission in ICUs or in ICU for ≤48h .

Sponsors & Collaborators

• Society of Indian Human & Animal Mycologist: lead

Study Sites (1)

Arunaloke Chakrabarti

Chandigarh, Uttarakhand, 160012, India

Location

Biospecimen

Retention: SAMPLES WITH DNA

Candida isolates

MeSH Terms

Conditions

Candidemia; Torulopsis

Condition Hierarchy (Ancestors)

Candidiasis, Invasive; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arunaloke Chakrabarti, MD

  PGIMER, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 21, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 19, 2014

Record last verified: 2011-01

Locations

IN (1)