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Invasive Candidiasis in ICU (ICIP-SA)

This study is currently recruiting participants.
Verified August 2012 by King Abdulaziz Medical City
Sponsor:
Information provided by (Responsible Party):
Hasan Al-Dorzi, King Abdulaziz Medical City
ClinicalTrials.gov Identifier:
NCT01490684
First received: December 2, 2011
Last updated: August 13, 2012
Last verified: August 2012
History of Changes
  Purpose

Epidemiology and clinical outcomes of invasive candidiasis in critically ill patients in Saudi Arabia is not well studied. This observational study objectives include to determine the epidemiology, risk factors and outcomes of invasive Candida infection in critically ill patients in Saudi Arabia.


Condition
Invasive Candidiasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Invasive Candidiasis in Critically Ill Patients in Saudi Arabia: A Prospective Cohort Study

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections
U.S. FDA Resources

Further study details as provided by King Abdulaziz Medical City:

Primary Outcome Measures:
  • ICU mortality [ Time Frame: Patients will be followed while in the ICU and the vital status at the time of discharge from the ICU will be noted. The expected stay in the ICU is 10 days on average. ] [ Designated as safety issue: No ]
    For patients staying in the ICU for long periods, ICU mortality will be censored at 180 days after entry into the study.That is patient staying alive in the ICU more than 180 days will be considered alive.


Secondary Outcome Measures:
  • hospital mortality [ Time Frame: patients will be followed until discharge from the hospital and vital status at discharge from the hospital will be noted (expected hospital stay is 5 weeks). Hopsital mortality will be censored at 180 days after entry into the study. ] [ Designated as safety issue: No ]
    If patients are still alive at 180 days after entring the sudy, they will be considered hospital survivors.

  • duration of mechanical ventilation [ Time Frame: date of extubtation minus date of intubation ] [ Designated as safety issue: No ]
    If multiple intubations in the same admission, then the durations of mechanical ventilation will be added.This will be assessed for up to 180 days of stay in the ICU.

  • length of stay in the ICU [ Time Frame: date of discharge from ICU minus date of admission to ICU ] [ Designated as safety issue: No ]
    Patients will be followed for up to 180 days.Patinets alive in the ICU beyond 180 days of stay will have an ICU length of stay of 180 days.

  • length of stay in the hospital [ Time Frame: date of discharge from hospital minus date of admission to hospital ] [ Designated as safety issue: No ]
    Patients will be followed for up to 180 days.Patinets alive in the hospital beyond 180 days of stay will have a hospital length of stay of 180 days.


Estimated Enrollment: 170
Study Start Date: August 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All adult patients (> 18 years) admitted to the ICUs of these centers will be evaluated for the occurrence of Candida infection and followed to discharge or death in ICU. The duration of the study will be 12 months. Also patients who had invasive candidiasis within 72 hours of ICU admission will be included.

Criteria

Inclusion Criteria:

  • adult patients (> 18 years)
  • develop invasive candidiasis as per prespecified definitions during ICU stay
  • In addition, patients who had invasive candidiasis within 72 hours of ICU admission will be included

Exclusion Criteria:

  • Diagnosis of invasive candidiasis (definite or probable) more than 72 hours before ICU admission.
  • Diagnosis of invasive candidiasis (definite or probable) within 72 hours of ICU admission, but the admission to ICU for an unrelated reason.
  • Readmission to the ICU during the same hospitalization with invasive candidiasis occurring during one of the previous admissions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490684

Contacts
Contact: Hasan M Al-Dorzi, MD 966535888632 aldorzih@yahoo.com

Locations
Saudi Arabia
King Abdulaziz Medical City Recruiting
Riyadh, Saudi Arabia
Contact: Hasan Al-Dorzi, MD     966535888632     aldorzih@yahoo.com    
Sub-Investigator: Yaseen Arabi, MD            
Sub-Investigator: Raymond Khan, MD            
Sub-Investigator: Sameera Al-Johani, MD            
Sub-Investigator: Tarek Al-Dabbagh, MD            
Sponsors and Collaborators
Hasan Al-Dorzi
Investigators
Principal Investigator: Hasan Al-Dorzi, MD King Abdulaziz Medical City
  More Information

No publications provided

Responsible Party: Hasan Al-Dorzi, Consultant, Intensive Care Department, King Abdulaziz Medical City
ClinicalTrials.gov Identifier: NCT01490684     History of Changes
Other Study ID Numbers: KAMC
Study First Received: December 2, 2011
Last Updated: August 13, 2012
Health Authority: King Abdullah International Medical Research Center, Riyadh, Saudi Arabia:

Keywords provided by King Abdulaziz Medical City:
candidiasis
critically ill
outcomes

Additional relevant MeSH terms:
Candidiasis
Critical Illness
Candidiasis, Invasive
 Mycoses
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013