Invasive Candidiasis in ICU

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01490684
• Date of registration: 02/12/2011
• Prospective Registration: Yes
• Primary sponsor: Hasan Al-Dorzi
• Public title: Invasive Candidiasis in ICU ICIP-SA
• Scientific title: Invasive Candidiasis in Critically Ill Patients in Saudi Arabia: A Prospective Cohort Study
• Date of first enrolment: August 2012
• Target sample size: 170
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01490684
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Saudi Arabia

Contacts

• Name: Hasan Al-Dorzi, MD
• Affiliation: King Abdulaziz Medical City

• Name: Hasan Al-Dorzi, MD

• Name: Hasan M Al-Dorzi, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Invasive Candidiasis

Primary Outcome(s)

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.]

Secondary Outcome(s)

length of stay in the ICU [Time Frame: date of discharge from ICU minus date of admission to ICU]

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.]

length of stay in the hospital [Time Frame: date of discharge from hospital minus date of admission to hospital]

duration of mechanical ventilation [Time Frame: date of extubtation minus date of intubation]

Secondary ID(s)

KAMC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors