Invasive Candidiasis in Saudi ICUs (ICIP-SA)

November 30, 2017 updated by: Hasan Al-Dorzi

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • King Fahad Medical City
      • Riyadh, Saudi Arabia
        • King Abdulaziz Medical City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients (> 18 years) admitted to the ICUs of these centers will be evaluated for the occurrence of Candida infection and followed to discharge or death in ICU. The duration of the study will be 12 months. Also patients who had invasive candidiasis within 72 hours of ICU admission will be included.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU 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.
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.
Duration of Mechanical Ventilation
Time Frame: 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.
date of extubtation minus date of intubation
Length of Stay in the ICU
Time Frame: 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.
date of discharge from ICU minus date of admission to ICU
Length of Stay in the Hospital
Time Frame: 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.
date of discharge from hospital minus date of admission to hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasan Al-Dorzi

Collaborators

King Fahad Medical City

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 10, 2011

First Posted (Estimate)

December 13, 2011

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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