Invasive Candidiasis in Saudi ICUs

Invasive Candidiasis Clinical Trial

— ICIP-SA  

Official title:

Invasive Candidiasis in Critically Ill Patients in Saudi Arabia: A Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490684
• Other study ID #: KAMC
• Status: Completed
• Start date: August 2012
• Est. completion date: May 2016

Study information

• Verified date: November 2017
• Source: King Abdulaziz Medical City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive
• Invasive Candidiasis

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz Medical City	Riyadh
Saudi Arabia	King Fahad Medical City	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
Hasan Al-Dorzi	King Fahad Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Mortality	For patients staying in the ICU for long periods, hospital mortality will be censored at 180 days after entry into the study.That is patient staying alive in the hospital more than 180 days will be considered alive.	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	ICU Mortality	If patients are still alive in the ICU at 180 days after entring the sudy, they will be considered ICU survivors.	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.
Secondary	Duration of Mechanical Ventilation	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.	date of extubtation minus date of intubation
Secondary	Length of Stay in the ICU	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.	date of discharge from ICU minus date of admission to ICU
Secondary	Length of Stay in the Hospital	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.	date of discharge from hospital minus date of admission to hospital