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Invasive Candidiasis in Saudi ICUs (ICIP-SA)

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ClinicalTrials.gov Identifier: NCT01490684
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
King Fahad Medical City
Information provided by (Responsible Party):
Hasan Al-Dorzi, King Abdulaziz Medical City

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Invasive Candidiasis
Enrollment 162
Recruitment Details  
Pre-assignment Details  
Arm/Group Title The Whole Cohort
Hide Arm/Group Description The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Period Title: Overall Study
Started 162
Completed 162
Not Completed 0
Arm/Group Title The Whole Cohort
Hide Arm/Group Description The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Overall Number of Baseline Participants 162
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants
58.4  (18.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
Female
77
  47.5%
Male
85
  52.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Saudi Arabia Number Analyzed 162 participants
162
1.Primary Outcome
Title Hospital Mortality
Hide Description 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.
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title The Whole Cohort
Hide Arm/Group Description:
The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Overall Number of Participants Analyzed 162
Measure Type: Count of Participants
Unit of Measure: Participants
95
  58.6%
2.Secondary Outcome
Title ICU Mortality
Hide Description If patients are still alive in the ICU at 180 days after entring the sudy, they will be considered ICU survivors.
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title The Whole Cohort
Hide Arm/Group Description:
The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Overall Number of Participants Analyzed 162
Measure Type: Count of Participants
Unit of Measure: Participants
83
  51.2%
3.Secondary Outcome
Title Duration of Mechanical Ventilation
Hide Description 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.
Time Frame date of extubtation minus date of intubation
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Length of Stay in the ICU
Hide Description 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.
Time Frame date of discharge from ICU minus date of admission to ICU
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title The Whole Cohort
Hide Arm/Group Description:
The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: days
42.4  (54.2)
5.Secondary Outcome
Title Length of Stay in the Hospital
Hide Description 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.
Time Frame date of discharge from hospital minus date of admission to hospital
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title The Whole Cohort
Hide Arm/Group Description:
The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: days
88.8  (87.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title The Whole Cohort
Hide Arm/Group Description The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
All-Cause Mortality
The Whole Cohort
Affected / at Risk (%)
Total   95/162 (58.64%) 
Show Serious Adverse Events Hide Serious Adverse Events
The Whole Cohort
Affected / at Risk (%)
Total   0/162 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
The Whole Cohort
Affected / at Risk (%)
Total   0/162 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Hasan Al-Dorzi
Organization: King Abdulaziz Medical City
Phone: 966535888632
Responsible Party: Hasan Al-Dorzi, King Abdulaziz Medical City
ClinicalTrials.gov Identifier: NCT01490684     History of Changes
Other Study ID Numbers: KAMC
First Submitted: December 2, 2011
First Posted: December 13, 2011
Results First Submitted: November 30, 2017
Results First Posted: August 24, 2018
Last Update Posted: August 24, 2018