Trial Outcomes & Findings for Invasive Candidiasis in Saudi ICUs (NCT NCT01490684)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

162 participants

Primary outcome timeframe

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.

Results posted on

2018-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	The Whole Cohort The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Overall Study STARTED	162
Overall Study COMPLETED	162
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Invasive Candidiasis in Saudi ICUs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Whole Cohort n=162 Participants The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Age, Continuous	58.4 years STANDARD_DEVIATION 18.9 • n=99 Participants
Sex: Female, Male Female	77 Participants n=99 Participants
Sex: Female, Male Male	85 Participants n=99 Participants
Region of Enrollment Saudi Arabia	162 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	The Whole Cohort n=162 Participants The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Hospital Mortality	95 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	The Whole Cohort n=162 Participants The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
ICU Mortality	83 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	The Whole Cohort n=162 Participants The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Length of Stay in the ICU	42.4 days Standard Deviation 54.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	The Whole Cohort n=162 Participants The whole cohort included one group of patients with invasive candidiasis as per the Inclusion and Exclusion Criteria.
Length of Stay in the Hospital	88.8 days Standard Deviation 87.2

Adverse Events

The Whole Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 95 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Hasan Al-Dorzi

King Abdulaziz Medical City

Phone: 966535888632

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place