ICIP-SA: Invasive Candidiasis in Saudi ICUs

• Sponsor: Hasan Al-Dorzi (Other)
• Overall Status: Completed
• CT.gov ID: NCT01490684
• Collaborator: King Fahad Medical City (Other)
• Enrollment: 162
• Locations: 2
• Duration (Months): 45
• Patients Per Site: 81
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Candidiasis

Study Design

• Study Type: Observational
• Actual Enrollment: 162 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Invasive Candidiasis in Critically Ill Patients in Saudi Arabia: A Prospective Cohort Study
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Outcome Measures

Primary Outcome Measures

1. Hospital Mortality [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.]

   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.

Secondary Outcome Measures

1. ICU Mortality [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.]

   If patients are still alive in the ICU at 180 days after entring the sudy, they will be considered ICU survivors.

2. Duration of Mechanical Ventilation [date of extubtation minus date of intubation]

   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.

3. Length of Stay in the ICU [date of discharge from ICU minus date of admission to 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.

4. Length of Stay in the Hospital [date of discharge from hospital minus date of admission to 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	King Abdulaziz Medical City	Riyadh		Saudi Arabia
2	King Fahad Medical City	Riyadh		Saudi Arabia

Sponsors and Collaborators

• Hasan Al-Dorzi
• King Fahad Medical City

Investigators

• Principal Investigator: Hasan Al-Dorzi, MD, King Abdulaziz Medical City

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hasan Al-Dorzi, Consultant, Intensive Care Department, King Abdulaziz Medical City
• ClinicalTrials.gov Identifier: NCT01490684
• Other Study ID Numbers: KAMC
• First Posted: Dec 13, 2011
• Last Update Posted: Aug 24, 2018
• Last Verified: Nov 1, 2017

• Keywords provided by Hasan Al-Dorzi, Consultant, Intensive Care Department, King Abdulaziz Medical City: candidiasis; critically ill; outcomes
• Additional relevant MeSH terms: Candidiasis; Candidiasis, Invasive

Study Results

Participant Flow

Arm/Group Title	The Whole Cohort
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

Baseline Characteristics

Arm/Group Title	The Whole Cohort
Arm/Group Description	The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Overall Participants	162
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.4 (18.9)
Sex: Female, Male (Count of Participants)
Female	77 47.5%
Male	85 52.5%
Region of Enrollment (participants) [Number]
Saudi Arabia	162 100%

Outcome Measures

1. Primary Outcome

Title	Hospital Mortality
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	The Whole Cohort
Arm/Group Description	The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Measure Participants	162
Count of Participants [Participants]	95 58.6%

2. Secondary Outcome

Title	ICU Mortality
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	The Whole Cohort
Arm/Group Description	The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Measure Participants	162
Count of Participants [Participants]	83 51.2%

3. Secondary Outcome

Title	Duration of Mechanical Ventilation
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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Length of Stay in the ICU
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	The Whole Cohort
Arm/Group Description	The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Measure Participants	162
Mean (Standard Deviation) [days]	42.4 (54.2)

5. Secondary Outcome

Title	Length of Stay in the Hospital
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	The Whole Cohort
Arm/Group Description	The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Measure Participants	162
Mean (Standard Deviation) [days]	88.8 (87.2)

Adverse Events

Arm/Group Title	The Whole Cohort
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 (%)	# Events
Total	95/162 (58.6%)
Serious Adverse Events
	The Whole Cohort
	Affected / at Risk (%)	# Events
Total	0/162 (0%)
Other (Not Including Serious) Adverse Events
	The Whole Cohort
	Affected / at Risk (%)	# Events
Total	0/162 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.